The purpose of this message is to communicate to you the plans that your children have developed and thought about for March 14, 2018. There has been a great deal of discussion and debate across our country on the purpose of this day and what this walkout means to students. For Brewer, our students have chosen to focus on honoring the victims of school shootings across our country and having the opportunity to ask questions about school safety and security. Your children have asked for an indoor space after hearing the Brewer Police Department and Brewer Administration had concerns about students congregating outside at a specific date and time. Given the number of threats being made to schools recently, our students have been incredibly understanding and responsible as they plan this event on March 14.
This event is organized by the students. They have asked that it be voluntary and that any student wishing to participate and honor the victims go to the gym at 10 AM on this day. During this time, the students will have a moment of silence, put their thoughts on a banner, make new friends, and create cards building on the Brewer Community of Caring they already value and appreciate. Students also have questions about school safety. During this time, the Brewer Police Department and administration will be present to answer questions they may have on school safety and security. The goal of this event is to give students the voice they are asking for in honoring the victims and helping our students feel safer in our schools by providing them with the answers to the questions they are asking.
The teachers have been listening to the students this week for any questions or needs regarding school safety. During a faculty meeting this Thursday, a discussion will occur to see if a similar plan to the high school is needed for the middle school students. At this time, any questions that are being asked by students are being handled by the administration, school resource officer or the teacher. A possible inside gathering for students with questions may occur if the need rises. Mr. Leithiser or I will communicate any further Community School plans with you.
I have listened to many of you over the last week and stated I would get back to you with the plans for this twenty-minute time frame. I am proud of the work that students have chosen to do and the proactive approach to the "walkout" they have taken. Our administrative team, school resource officers, faculty and emergency response teams continue to review and practice our safety and security protocols. We also continue to look for ways to enhance and build upon the practices we already have in place.
I thank you for your patience over the last two weeks. I hope you can appreciate the work of your children. It is an honor to work with them daily. They truly are incredible children with caring hearts and a capacity to give to their community by learning how they can improve the safety of their schools. If you have further questions, please call the Superintendent's office at 989-3160.


Represented the U.S. operations of a Spanish Company in the automotive metal stamping business, in connection with its purchase of a stamping facility in South Carolina.
Represented private equity firm in multi-million dollar acquisition of large fast-food restaurant franchisee and prepared an HSR premerger notification filing in connection with the transaction.
Represented the majority owners of a manufacturer of digital imaging equipment in the sale of all of its membership interests.
Prepared numerous HSR premerger notification filings for public medical malpractice insurer.
Represented ball bearing manufacturing in sale of substantially all of the assets of one of its subsidiaries.
Represented manufacturer of luxury vinyl flooring in connection with the sale of substantially all of its assets.
Assisted in the disposition of certain assets of a liquidation trust, including the disposition of hundreds of acres of timberland.
Represented larger supermarket chain in the sale of certain pharmacy assets out of bankruptcy.
Prepared HSR premerger notification form in conjunction with in the sale of stock of a manufacturer of clothing and sportswear.
Represented client in the acquisition of the membership interest of B.A.S.S., LLC (a magazine publisher and outdoor entertainment company) from ESPN Productions, Inc.
Represented various nursing home clients in refinancing and/or assumption of over $150 million in HUD-insured loans.
Assessed and provided opinions of data breach implications during due diligence of prospective corporate acquisitions.
Represented client in acquisition of provider of on-line platform for academic skill building and standardized test preparation.
April practices in Burr & Forman's Corporate and Tax practice group, representing clients in connection with a broad range of business matters, including mergers and acquisitions, financing, corporate governance, franchising, and antitrust.
April has been involved in a variety of mergers and acquisitions with domestic and foreign, public and privately held clients in the manufacturing, technology, insurance, healthcare, retail and restaurant/hospitality industries. Additionally, she regularly counsels start-ups and seed companies as they seek venture funding for their company.
She has worked on numerous acquisitions involving franchised concepts and advised on franchise issues pertaining to all aspects of the transaction. Her experience includes counseling both franchisors and franchisees on federal and state disclosure requirements and various state relationship laws that pertain to dealer/franchise terminations.
April also regularly counsels clients on antitrust issues, including merger review and Hart-Scott-Rodino premerger notification filings, competitor collaborations and joint ventures, FTC and DOJ investigations, distribution arrangements and trade association activities, as well as advises on antitrust exemptions and immunities.
April served as corporate counsel for a sports event management and marketing company. As corporate counsel, April drafted, reviewed and negotiated various venue, sponsor and vendor contracts related to major sporting events in Alabama. She was also responsible for managing the relationship with the Alabama High School Athletic Association, which involved developing a media rights plan and negotiating broadcast agreements, as well as managing their corporate sponsorship program.
Burr Alert: Buying a Corporate Jet? Talk to Us First!


The marvelous image below, is segment of The 2019 Dodge Barracuda Hellcat Wallpaper written piece which is labeled within Review, 2019 dodge challenger hellcat redeye, 2019 dodge challenger hellcat redeye for sale, 2019 dodge challenger hellcat redeye widebody and posted at December 14th, 2018 12:38:44 PM by wendy.
We reviews the 2019 Dodge Barracuda Hellcat where consumers can find detailed information on specs, fuel economy, transmission and safety. We reviews the 2019 Dodge Barracuda Hellcat Concept where consumers can find detailed information on specs, fuel economy, transmission and safety.
Inside, the 2019 Dodge Barracuda Hellcat is similarly cluttered. Its dashboard is upright and places climate and audio controls on the prime of the middle stack, but secondary switches are tucked low and are laborious to reach. The 2019 Dodge Barracuda Hellcat boasts a snug journey, but acceleration is hardly breathtaking.
Explore the design, performance and technology features of the 2019 Dodge Barracuda Hellcat. See models and pricing, as well as photos and videos. The 2019 Dodge Barracuda Hellcat Release goes to excess the right kinds of excess to preserve its best-of status. Find out if the new 2019 Dodge Barracuda Hellcat coupe takes a step forward in our first-drive review. See photos and get the story at Car and Driver.
Reviews, videos, latest news, specs and road tests on the 2019 Dodge Barracuda Hellcat. Top Gear reviews the Redesign. Terrific refinement, class-leading technology, and incredible interior quality. Want to know more? Read more.
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Let me be this straight on this subject it's as plain as black and white it is so Un-American to be Un-American. There are many who claim to be patriots and extolling the virtues of being pro-American but their actions and words tell a different story.
In January 2017 when President Trump urged select members of Congress (party leaders of both sides of the isle) to do a comprehensive immigration reform and fix the broken immigration law produced nothing except resistance. Instead of going back to The Hill (as it is called) calling a special session of Congress and directing appropriate committees to begin fixing the problem House Leader Paul Ryan and Senate Majority Leader chose instead to do nothing.
Even the urging of Congress to create legislation turning DACA into law produced no results, only outrage that an "illegitimate" President would ask such a thing.
The outrage continued as the President request funding for Homeland Security to improve border patrol by increasing agents and updating computer and electronic equipment and software to enable a tighter reign over illegal crossings and funding "The Wall".
I'm talking about legislators who've made Congress into a career. Many have been in political power since the days of Ronald Reagan! The immigration crisis is a very real one and any legislator who chose to side with the hijacked Democratic Party is totally responsible for any and all actions resulting in death or injury to criminals who have crossed over illegally.
Not only Congress, but the main stream media which the President has labeled "Fake News" has not honestly reported on the happenings in our nation, but have fallen into the trap of spreading inaccurate and unverified reports which lead to mass hysteria and rioting in the streets across America.
The American people who cannot see for themselves or distinguish between right and wrong are equally to blame. In fact maybe even more so because they have repeatedly elected unscrupulous and dishonest politicians or kept them in office because of the offer of free stuff, have they sold their soul for a free phone, free medicine, free education, free food or a free home where one simply exists in order to get that welfare check?
"Asking not what you can do for your country, but asking what can your country do for you" is not what President Kennedy said.
"That shining city upon a hill" that President Reagan spoke of is not a national ATM machine which you can tap into when you run out of stuff.
Fighting against President Donald Trump because you allow yourself to be "offended" is inexcusable. It is a choice to be "Offended".
It is Un-American to be Un-American and if you are not part of the solution to Make America Great Again then you ARE part of the problem that is wrong in America. If you welcome illegal aliens with open arms yet see nothing wrong or immoral with aborting babies in the womb or even after birth – You Are The Problem!
If you cannot or will not pledge your "allegiance to the United States of America, one nation under God, indivisible with liberty and justice for all" you do not deserve nor should you be allowed to remain in this land of opportunity where everyone is born equal in the eyes of God.
It is the patriot, whether civilian or military that stands firm shoulder to shoulder with brothers and sisters-in-arms insuring that we are all able to enjoy the rights and freedoms guaranteed by the Constitution of the United States which is the "Rule of Law" in the United States of America.
If you are not for America you are against America and by your own choice. There are more than 70,000,000 able bodied Americans who have taken an oath to protect and defend the Constitution of the United States against ALL enemies both foreign and domestic. We have chosen to obey the orders of the President and the officers appointed over us – So Help Us God!
It is Un-American to be Un-American! – I am the Real Truckmaster!


Skin sensitivity to moderately warm or cold temperatures can affect comfort, usability and injury potential. To quantify the thermal characteristics of materials that come in contact with the skin, surface temperature may be measured. Common applications include seating, hand tools, mattresses and other product that a user may come in contact with. The thermal performance may allow product comparisons or be assessed relative to desirable thermal limits.


← Why are bogeys green?
Why was Gandalf in Lord of the Rings yet not in Star Wars?
A very good question, considering that Gandalf is not only a very powerful force on planetary scale, but also immortal.
However, it is the source of his immortality that unlocks this particular riddle.
Gandalf, as all the wizards, is a kind of demi-god sent to counter Sauron and protect the Children of Ilúvatar; the races of Middle Earth as created in song by Ilúvatar and the other Ainur (creators). His original name back in those early days was Olórin. These powerful beings can be killed physically, as Gandalf the Grey was, but if they have further quests to attend to then they can come back in a different physical incarnation (Gandalf the White). Although he is a lesser member of the Ainur, he is closely linked to the land and Earth itself, and feels duty-bound to protect it and the inhabitants.
So our tale begins with the world as it was after the Ring was destroyed and order restored. Peace took hold in the aftermath and Middle Earth enjoyed a prosperous and fast-paced few centuries. Industrial revolution swept the landscape and technology grew in leaps and bounds. The hobbit communities tried to remain islands of uncomplicated agriculture while the Elves and men embraced the future, and Gandalf watched closely to make sure folk didn't get themselves into trouble again.
During his travels, Gandalf came into the company of a pretty elf-hobbit halfbreed. Never having taken a partner due to the constraints of his immortality and guardianship, he finally felt that there is only so much "YOU SHALL NOT PASS" a man can be bothered with in his life. She was immortal, from her elf lineage, but also possessed the stature and quaint appeal of the hobbits he had been so fond of looking after since the dawn of time. It seemed a perfect match. And Gandalf took this lady as his betrothed, to settle in the Shire and watch over the land from there.
As they built their home and began to consider raising a family in the lull while Middle Earth seemed reasonably danger-free, the Elves and men began breaking away to explore the sky. They launched higher and faster than even the Nazgûl had gone before. The day Gandalf's son was born, the first live-in space center was sent into orbit. The boy grew fast, and smart, and had a fascination with the new space travel. He wanted nothing more than to journey through the stars. He studied hard at school and it all seemed to come very easily to him; the son of a demi-god and an elf hybrid, he had brains and untrained power in buckets.
The boy grew older, and he learned much from his family. He also began research of his own, wondering what it was that gave him, Gandalf, and the other Ainur their abilities. After many years of humble life on his father's farm, he discovered the secret of Midichlorians and finally understood how to sense, isolate and train the Force in himself and others.
And it was on that day that Yoda said goodbye to his wizard father and elf-hobbit mother in the Shire and went forth into the galaxy to found the Jedi Council and train those in the use of the Force for protecting other planets than his own.
OMG! It all makes sense now!


text:
ABOUT MONO MONTHLY
Tsunagu Sonogi Tea Farmers
About the exhibitor
Tsunagu Sonogi Tea Farmers is a group of young six tea farmers that produce superlative green tea in the countryside of Nagasaki. Aged between 20 and 40, these six are steeped in the tradition of tea growing, with some the third- and even fourth-generation heirs of tea-growing families. They handle not only the cultivation of the tea plants, but also the harvesting and processing of the leaves. By doing so, they hope to be able to tell more people about their tea and continue well into the future.
In 2018, Sonogi Tea won top prize in Japan's National Tea Competition for the second year running. Sonogi Tea will be selling this tea — the finest in Japan — at MONO Japan.
SIX SENSES
These six teas were produced by Sonogi Tea's six founders, using all five of their senses as well as their intuition, or sixth sense. All six are meticulously produced single origin teas, which means that you can taste their unique terroir: from the specific field to the producer and the type of plant. You can also choose to mix them if you wish, and to discover your ideal blend. Six Senses won first prize in the World Green Tea Contest, and scooped the package prize as well.
The teas are as follows:
Ooiwase / Saemidori / Tsuyuhikari / Yabukita / Okuyutaka / Okumidori
The green tea which won the first prize in the prestigious Japan's National Tea Competition
The landscape of the Sonogi Tea farm
The six tea farmers

redpajama_set_name: RedPajamaCommonCrawl


If interacting with patients is part of your job, think for moment about a patient's typical complaints. The feedback will vary from person to person, sure, but no matter where you go or what type of patient you interview, you'll no doubt encounter a handful of universal grievances.
It's too hard to get in touch with my doctor.
It takes too long to make an appointment.
I can't keep track of my prescriptions and records.
Sound familiar? These are the day-to-day logistical challenges all healthcare providers face, and leaders in the field must seek out ways to address them successfully.
As explained by our co-founder Raj Amin in this post, patient portals present one of the biggest opportunities in healthcare. A patient portal serves as a one-stop digital solution to meet patients' needs, and numerous studies have shown that when combined with EHRs, patient portals have a significant ability to improve access to and quality of care.
Gone are the days of faxing records and lab results. With ManaPortal's easy messaging platform, patients can communicate directly with their clinician in a secure, email-like environment.
This not only helps the patient, but assists with clearing some of the bottleneck that occurs with phone communication. In a study of 15 California practices, researchers found those that implemented a web-based portal saw an 18% reduction in call volume over those that did not use such a portal.
Using a patient portal, patients can see a number of complex medical records in an easy-to-understand, tile-based interface. With ManaPortal, records are available for viewing, downloading, and sending, meeting the requirements for Meaningful Use Stage 2 attestation.
Consumer devices like Fitbit and Jawbone are now as common as the ordinary wristwatch. A patient portal allows patients to see the data from their favorite devices side by side with their clinical data for a unified view. This is critical to helping them get a clearer picture of their overall wellness.
Just as some prefer reading a newspaper while others enjoy an e-reader, some patients understand complex health concepts better when using video. A patient portal allows you to incorporate educational materials in the form of video so you're no longer limited to text or in-person face time.
Since their early inception more than a decade ago, patient portals have been linked with increased efficiency of care, improved management of chronic illness, and higher engagement levels among patients, which are demonstrated through measurable results.
Similarly, the majority of users of My Wellness Portal, a service of the Oklahoma Physicians' Resource/Research Network, reported that the portal was a "valuable resource," while 60% said it made them feel more connected with their doctors.
Finally, in a study involving more than 35,000 chronic care patients, Kaiser Permanente found a direct correlation between a secure web-based messaging portal and improved quality of care scores.
The numbers don't lie; patient portals are a tangible tool for noticeably increasing patient satisfaction rates and outcomes.
Want to find out how ManaPortal can lead to more satisfied patients within your organization? Get in touch with us now.


Wood for burning in a wood stove must be "dry" to burn with maximum efficiency. "Dry" means the wood must be aged, so it is not "green" and also not "wet" from rainwater. When a tree is cut down, the wood is "green," or saturated with water through the normal capillary action needed to keep the tree alive. Depending upon the exact tree specie, it can take well over six months of normal storage for the wood to "season" and no longer be "green." If you harvest your firewood in late summer or early fall, you can cheat and speed up the seasoning process. I am assuming you use a stick for measuring* where to cut, so all the pieces are the same length and therefore will stack reasonably well in a single row.
The quickest way to season firewood is to stack it in a single row along a fence, if possible, and slightly lower than the height of the fence. At that point, clear plastic sheeting, 4 mil thickness recommended, can be draped over the fence and the firewood. To keep the plastic tarp from blowing off, place a piece of lead or a smooth rock on the edge of the tarp, roll the tarp over the rock, then tie the tarp beneath the rock with heavy twine. Repeat every 4 feet and at the corners. The smooth folds of the tarp will prevent if from tearing, while the weight of the rock or lead ingot will keep the plastic sheet from blowing away. The plastic sheet need only cover the top of the wood stack and down to a foot or so off the ground. The sun heats the wood, condensation form upward against the plastic sheet, then drains down the side.
What you have done is create a miniature greenhouse! The fence keeps the tarp above the wood, and being draped over the fence, it does not touch the wood on that side. The heat of the sun is trapped by the plastic tarp, the wood heats up, and natural condensation forms on the plastic tarp, draining moisture away from the wood beneath it. With this method, it is possible to dry "green" wood into a burnable condition within only 4 to 6 weeks, and it will be ready for use in the winter. The firewood may then be stacked for storage and use.
A "cord" of wood is 4 feet high, 4 feet wide, and 8 feet long, or 128 cubic feet. A stack of 16" wood 4 feet high and 8 feet long is 1/3rd of a cord, and is also called a "face cord." It takes three "face cords" to equal a cord of wood. Therefore, a stack of 16" pieces of wood stacked 4 feet high and 24 feet along a fence is a whole cord. If loosely stacked, 18" lengths of wood also can add up to 1/3rd of a cord, as the "volume" is deceptive because the wood can be stacked loosely.
If you have wood delivered "by the cord" make sure it is stacked up, not just dumped in a pile, or you may well find that your delivery is NOT a whole cord of wood – what you paid for.
Freshly cut green wood is very heavy, If you order wood delivered and it comes in the back of a 3/4th ton pickup, you are NOT getting a whole cord of wood, period. The truck cannot carry that much weight safely (3,000 to 5,000 pounds), nor can it hold the volume of a cord. A standard long pickup bed is 8 feed in length, 5 feet in width, and less than 2 feet in height. That is 80 cubic feet of wood, not the 128 cubic feet in a whole cord. Even if the wood is stached up higher on the pickup bed, say to an average of 3 feet high, it is still less than a cord, and the weight would have the bed of the pickup right down on the rear axle with the front end almost off the ground – very unsafe driving conditions.
Firewood should be stacked off the ground so air can pass beneath it, or the bottom layers will stay wet and moldy. It is relatively simple to lay down long, straight branches, and stack the wood on them – just be sure the branches ) or old 2 x 4's, whatever is available) are parallel to the stack and near the outer sides of each row or rick.. in other words, about 15 inches apart. That way, the stacks will still be stable.
The entire stack of firewood may then be covered with a tarp to keep it dry. Lashing a tarp over a stack of firewood does not work well, as wind will enter somewhere and tear the tarp. Weights tied to the grommets on the tarp will work vastly better.


Two cases illustrate the many benefits, and some of the risks, of minimally invasive management.
Is this tool the cure for wrong-site surgery and other OR errors?
WHO wants its checklist to be a catalyst for safety. Just by its presence in surgery, the plan might come off.
What percentage of cerebral palsy cases might be associated with intrapartum asphyxia?


Santa Cecilia granite is the most famous and trending granite in this era. The classy and pretty design of the granite will make you drool and cannot wait to own it right now. This design is suitable for all of the design available. It is suitable with classic and also country style. It also goes well with contemporary style. The design can get along well with any style and design which is the answer why this granite is totally famous. You cannot help but praise this style as well since it is the best answer for you who want an awesomely style which can blend with any style and design. Today we will talk about this trending santa Cecilia.
Which Design Suit This Granite the Best?
Yes, that is true that this kind of granite goes along well with all of the design, but there is a design which will obviously make your kitchen style balance well. Santa Cecilia classic granite will goes along with an obviously classic style. This will be the best way to make your kitchen in sync and get your kitchen prettier. The balanced design will never make an awkward style, because instead it will make a one of a kind unique style which everyone hopes to own. The classic design of a kitchen will be better if it has santa Cecilia granite as the basic material. Classic kitchen design with this granite will be going well, and also balance as if it is really meant to be to complete each other. This has to be in your to do list.
To make the granite stand out more, there are some idea that you can pursue and get it into reality. Santa Cecilia granite backsplash idea will be the best one to begin with. The backsplash will obviously be the most stand out part from all of the kitchen's part. This will help the overall feels of the kitchen to be in sync and get your granite looks better than the rest. The granite will be the first thing everyone see on your kitchen since it will stand out as a main point of your kitchen. It will give an impression which cannot be forgotten by anyone easily since it is unique and have such a high quality which everyone hopes to own.
Make a unique style which is different but is unique to get your kitchen stand out more. That is all about santa Cecilia granite.


We can provide a full range of payment methods for paying your rates, fees and infringements.
by direct debit (download a direct debit application form (PDF), or collect one at the council offices or by phoning 03 6211 8205.
These can be paid either over the phone (6211 8200) or online via BPOINT using a credit card, or at the Civic Centre, 15 Channel Hwy, Kingston.


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Research ArticleVasculitis
Efficacy of Methotrexate in Real-world Management of Giant Cell Arteritis: A Case-control Study
Matthew J. Koster, Karthik Yeruva, Cynthia S. Crowson, Francesco Muratore, Cristian Labarca and Kenneth J. Warrington
The Journal of Rheumatology May 2019, 46 (5) 501-508; DOI: https://doi.org/10.3899/jrheum.180429
Matthew J. Koster
From the Mayo Clinic College of Medicine and Science, Department of Internal Medicine, Division of Rheumatology, and the Mayo Clinic College of Medicine, Department of Health Sciences Research, Rochester, Minnesota, USA; Division of Rheumatology, Azienda Ospedaliera, Unità Sanitaria Locale–Institute for Research and Health Care (USL-IRCCS) di Reggio Emilia e Università di Modena e Reggio Emilia, Modena e Reggio Emilia, Italy; Universidad Del Desarrollo, Clinica Alemana, Santiago, Chile.
For correspondence: koster.matthew@mayo.edu
Karthik Yeruva
Cynthia S. Crowson
Francesco Muratore
Cristian Labarca
Kenneth J. Warrington
Objective. To determine the effect of methotrexate (MTX) on relapse risk and glucocorticoid (GC) use in a large single-institution cohort of patients with giant cell arteritis (GCA).
Methods. Patients diagnosed with GCA from 1998 to 2013 with confirmed evidence of temporal artery biopsy and/or radiographic evidence of large vessel vasculitis were identified. Each patient with GCA treated with adjunct MTX (case) was matched to a similar patient with GCA treated only with GC (control). GC requirements and relapse events before and after MTX initiation (or corresponding index date) were compared using rate ratios (RR).
Results. Eighty-three cases and 83 controls were identified and compared. No significant differences in age, demographics, laboratory variables, baseline disease characteristics, or mean initial prednisone doses were observed. Median [interquartile range (IQR)] time from GCA diagnosis to MTX initiation in cases was 39 (13–80) weeks and the median (IQR) starting dose was 13.5 (10–15) mg/week. RR comparing relapse rates before and after MTX initiation/index date were significantly reduced in both cases (RR 0.32, 95% CI 0.24–0.41) and controls (RR 0.60, 95% CI 0.43–0.86). The decrease in relapse rate was significantly greater in patients taking MTX than in those taking GC alone (p = 0.004). Rates of GC discontinuation did not differ between groups.
Conclusion. In this large single-institution cohort, the addition of MTX to GC decreased the rate of subsequent relapse by nearly 2-fold compared to patients taking GC alone. MTX may be considered as adjunct therapy in patients with GCA to decrease the risk of further relapse events.
Key Indexing Terms:
GIANT CELL ARTERITIS
Giant cell arteritis (GCA) is the most common primary systemic vasculitis among patients aged ≥ 50 years and has a predilection for affecting the aorta and its primary branches1. Because of associated severe ischemic complications including vision loss, stroke and aortic aneurysm/dissection, prompt diagnosis and initiation of treatment is required2,3. High-dose glucocorticoids (GC) followed by a tapering regimen have remained the mainstay for treatment of patients with GCA4,5.
Despite treatment with GC, 40–75% of patients experience at least 1 relapse during the course of followup6,7. Patients experiencing relapses have demonstrated both a longer duration and greater cumulative exposure to GC8. Unfortunately, longterm GC treatment in the age group affected by GCA is associated with a high number of adverse events, which have been reported in 86–100% of patients8,9.
Tocilizumab (TCZ), an interleukin 6 (IL-6) receptor inhibitor, in combination with an accelerated (26-week) GC taper, has recently been shown to be effective in the treatment of both newly diagnosed and relapsing patients with GCA10. However, the substantial cost of this targeted biologic may preclude its use in some patients with GCA. Methotrexate (MTX) is a less expensive option for treatment, but clinical trial use of this agent in newly diagnosed patients with active disease has provided conflicting results11,12,13. A meta-analysis of individual patient data from these studies demonstrated a modest reduction in cumulative GC use and moderate absolute reduction in relapse risk; however, a reduction in GC-associated adverse events was not observed14. Findings from the metaanalysis have also suggested that the disparate results from the individual clinical trials may be in part due to inadequate sample sizes, as well as differences in trial design regarding dose of MTX chosen, method of steroid tapering, choice of outcome measures, number of relapses allowed and length of followup14.
Clinical trials evaluating MTX among patients with established relapsing disease have not been performed to date, and cohort studies describing the efficacy of MTX in GCA are limited15,16. The purpose of this study was to describe the use of MTX in a large cohort of patients with relapsing GCA and compare them to patients with GCA receiving only GC therapy from the same institution.
A retrospective chart review was performed identifying all patients diagnosed with GCA from 1998 to 2013, combining 2 previously defined cohorts7,17. Patients diagnosed with GCA were ≥ 50 years of age, had clinical symptoms consistent with GCA and had either a positive temporal artery biopsy and/or radiographic evidence of large-vessel vasculitis. Findings considered compatible with large-vessel vasculitis included the presence of one or more of the following: circumferential wall thickening and/or the presence of vascular stenosis/occlusion and/or vascular dilatation/aneurysm not attributed to atherosclerotic changes on computed tomography angiogram; presence of circumferential wall thickening/wall edema with or without contrast enhancement and/or the presence of vascular stenosis/occlusion and/or vascular dilatation/aneurysm not attributed to atherosclerosis on magnetic resonance angiogram; arterial hypermetabolism demonstrated by fluorodeoxyglucose uptake compatible with vasculitis on 18F-fluorodeoxyglucose positron emission tomography (FDG-PET). Ultrasonography was not used in our study to evaluate for large-vessel involvement.
All patients treated with adjunct MTX during the course of their disease were identified. Each patient with GCA treated with adjunct MTX (case) was matched to a similar patient with GCA treated with only GC (control). Cases and controls were matched on age, sex, disease duration, and initial GC dose. Each control was assigned an index date to make the number of days from GCA diagnosis to index date in the control equivalent to the number of days from GCA diagnosis to the start of MTX in cases.
Baseline demographics, disease characteristics, and relapse events were abstracted. Relapse was defined as the reappearance of symptoms of GCA and/or polymyalgia rheumatica associated with an increase in erythrocyte sedimentation rate and/or C-reactive protein for which treatment was escalated. Timing of initiation, initial dose, and titration/taper of MTX and GC were not standardized and were at the discretion of the treating provider. Use and adherence to prescribed MTX dosing regimens were evaluated through the prescribing physician's routine documentation of patient-reported compliance at the time of each physician visit. Dose reduction of MTX was defined as a decrease in MTX ≥ 25% of the current dose for ≥ 3 months. Discontinuation was defined as permanent cessation of treatment without subsequent reintroduction. Transient interruptions (≤ 6 weeks) for minor infection, surgical procedure, or failure to obtain medication from pharmacy were not considered as either MTX dose reduction or discontinuation. Lack of efficacy and sustained clinical response was determined by the treating rheumatologist.
Descriptive statistics (means, medians, percentages, etc.) were used to summarize the data. Comparisons between groups were performed using chi-square and rank-sum tests. Relapse rates were defined as the total number of relapses (including multiple relapses per patient) divided by the total number of person-years of followup in each group. GC requirements and relapse events before and after MTX initiation (or corresponding index date) were compared using rate ratios (RR). RR for relapses were calculated individually for cases and controls, comparing the rate of relapses before and after MTX initiation (cases) or corresponding index date (controls). In addition, the reduction in the relapse rates between cases and controls was compared to estimate the treatment effect. CI of 95% were computed for RR assuming that the observed number of relapses in each group followed a Poisson distribution. Adjustment for initial GC dose at GCA diagnosis and time-dependent covariates for GC use during followup was performed using conditional frailty models, which are a variation of Cox models that account for multiple relapses in the same patient using a random subject effect. Analyses were performed using SAS version 9.4 (SAS Institute) and R 3.2.3 (R Foundation for Statistical Computing).
This study was approved by the Institutional Review Board (IRB) of the Mayo Clinic, Rochester, Minnesota, USA (IRB# 14-001179).
A total of 83 patients with GCA receiving MTX (cases) were identified and compared to 83 patients with GCA receiving GC only (controls). Mean (± SD) age at diagnosis was 69.4 ± 7.0 years in cases and 70.2 ± 7.1 years in controls. Median [interquartile range (IQR)] followup for cases was 4.0 (2.3–6.0) years and 3.9 (2.3–7.7) years for controls (p = 0.43). No significant differences in demographics, laboratory variables, or baseline disease characteristics were observed between groups (Table 1).
Characteristics of patients with GCA treated with GC plus adjunct MTX compared to GC alone.
Mean initial prednisone doses at GCA diagnosis were similar (53.7 ± 14.7 mg/day in cases, 54.3 ± 13.7 mg/day in controls). The median (IQR) time from GCA diagnosis to MTX initiation in cases was 39 (13–80) weeks and the median (IQR) starting dose of MTX was 13.5 (10–15) mg per week. Median maximum MTX dose (mg/week) was 15.0 (12.5–20.0). Prior to MTX initiation, 24 patients (29%) had not yet experienced a relapse, whereas 23 patients (28%) had 1 relapse, 19 (23%) had 2 relapses, and 17 (20%) had 3 or more relapses. In comparison, at index date among patients receiving only GC (controls), 59 (71%) had not yet experienced a relapse, 9 (11%) had 1 relapse, 10 (12%) had 2 relapses, and 5 (6%) had 3 or more relapses.
The observed relapse rate prior to MTX initiation (cases) was 11.8 relapses per 10 person-years and decreased to 3.72 relapses per 10 person-years following introduction of MTX. The RR comparing relapse rates observed after MTX to the rate prior to initiation was significantly reduced (RR 0.32, 95% CI 0.24–0.41). Adjusting for GC starting dose and GC use during followup, the RR for comparing the relapse rates before and after MTX initiation in the MTX arm was slightly attenuated, with an HR of 0.36 (95% CI 0.27–0.48), but it remained significant. In the control group the relapse rate was 4.45 relapses per 10 person-years before the index date and 2.68 relapses per 10 person-years following the index date (RR 0.60, 95% CI 0.43–0.86). Although both groups had a reduction in relapse rate, the decrease in relapse rate was significantly greater in patients taking MTX (cases) than those taking GC alone (controls; p = 0.004; Figure 1).
The relapse rate of patients taking methotrexate (MTX) decreased from 11.8 relapses per 10 person-years to 3.72 relapses per 10 person-years following introduction of MTX. In those not taking MTX, the relapse rate was 4.45 relapses per 10 person-years before the index date and 2.68 relapses per 10 person-years following the index date. Although both groups had a reduction in relapse rate, the decrease in relapse rate was significantly greater in patients taking MTX than those not taking MTX (p = 0.004).
A subset analysis of only relapsing patients was additionally performed. Owing to the higher frequency of relapses in the MTX group, cases and controls could not be individually matched on the number of relapses prior to MTX initiation/index date without significantly reducing the number of matched pairs. Therefore, patients were categorized as relapsers if 1 or more relapses occurred prior to MTX initiation or index date. In total, 59 patients in the MTX group had 1 or more relapses prior to MTX initiation, whereas only 24 patients in the GC-only control group had relapsed prior to index date. The relapse rate in the cases was 12.22 relapses per 10 person-years prior to index date and decreased to 3.21 relapses per 10 person-years after MTX initiation (RR 0.26, 95% CI 0.19–0.36). For the control group, the relapse rate prior to index date was 7.00 and decreased to 1.65 (RR 0.24, 95% CI 0.13–0.42). The decrease in relapse rates between cases and controls among patients with 1+ relapse prior to MTX initiation/index date was similar (p = 0.74). In comparing the complete case and control cohorts, time to first relapse following MTX initiation/index date did not differ (Figure 2). Among patients treated with MTX that relapsed, 34.5 ± 5.8% had experienced at least 1 subsequent relapse at 1 year and 63.7 ± 8.1% at 5 years, compared to 35.5 ± 5.7% and 77.6 ± 10.2% at 1 year and 5 years, respectively, in the GC-only group (p = 0.65).
Time to first relapse after methotrexate (MTX) initiation/index date comparing patients treated with MTX plus glucocorticoids (GC) versus GC alone.
The median (IQR) cumulative prednisone dose at the time of MTX initiation/index did not differ between groups [cases: 9.5 g (4.7–14.8); controls 8.1 g (3.2–10.8), p = 0.15]. The mean dose of prednisone at time of MTX initiation in cases was 24.4 mg (± 16.6) and 20.5 mg (± 21.0) in controls (p = 0.02). The rates of prednisone tapering were similar between cases and controls throughout the study period (Figure 3). The mean annual prednisone dose reduction for cases and controls was also similar throughout followup (Appendix 1). The RR after MTX initiation/index date did not differ between cases and controls for achieving steroid doses of < 10 mg/day for > 6 months (RR 0.77, 95% CI 0.52–1.15) or steroid discontinuation for > 6 months (RR 0.90, 95% CI 0.47–1.64). Although the rate of steroid tapering did not differ between groups, because patients in the MTX group started at a higher prednisone dose, the median additional cumulative prednisone dose from MTX start/index date to 1 year and 2 years after start/index was higher in patients receiving MTX [1 yr: 5.0 g (3.9–8.4); 2 yrs: 8.1 g (5.4–14.1)] compared to patients receiving GC alone [1 yr: 3.5 g (1.7–7.4), p = 0.009; 2 yrs: 5.7 g (2.2–9.1), p = 0.01].
Prednisone tapering during study period. Average prednisone dose (mg/day) from methotrexate (MTX) initiation/index date in cases (solid line) compared to controls (dotted line).
Information regarding longterm tolerability of MTX was available for 79 of the 83 patients. During the course of followup the MTX dose was decreased by ≥ 25% in 23 patients; 5 (22%) of the decreases were due to adverse drug event and 18 (78%) secondary to sustained clinical response. Reported adverse events leading to dose reduction were fatigue (n = 1), gastrointestinal intolerance (n = 1), dizziness (n = 1), myelosuppression (n = 1), and drug interaction (n = 1). At 1 year, 2 years, and 5 years of followup, the percentage of patients (± standard error) with reduction of MTX ≥ 25% due to adverse event were 4.0 ± 2.3%, 7.4 ± 3.2%, and 7.4 ± 3.2%, respectively (Figure 4). However, the percentage of patients (± standard error) with dose reduction of MTX ≥ 25% due to sustained clinical response was observed in 4.0 ± 2.3% at 1 year, 11.8 ± 3.9% at 2 years, and 34.9 ± 8.3% at 5 years.
Methotrexate (MTX) tolerability in patients with giant cell arteritis. Upper panel: time from MTX initiation to reduction of MTX by ≥ 25% because of adverse event (dashed line) or sustained clinical response (solid line). Lower panel: time from MTX initiation to discontinuation because of adverse event (dashed line), lack of efficacy (dotted line), or sustained clinical response (solid line).
MTX was discontinued during followup in 33 patients. Reasons for discontinuation included adverse drug event (n = 16, 48%), lack of efficacy (n = 6, 18%), and sustained clinical response (n = 11, 33%). Discontinuation included the following non-mutually exclusive reasons: fatigue (n = 5), gastrointestinal intolerance (n = 5), alopecia (n = 2), dizziness (n = 2), transaminitis (n = 2), myelosuppression (n = 2), cough (n = 1), and other (n = 2). At 1 year, 2 years, and 5 years of followup, the percentages of patients (± standard error) with discontinuation of MTX due to adverse event were 14.5 ± 4.1%, 17.7 ± 4.5%, and 23.1 ± 5.7%, respectively (Figure 4). The percentages of patients (± standard error) with discontinuation of MTX due to lack of efficacy were 4.1 ± 2.3% at 1 year, 7.2 ± 3.1% at 2 years, and 9.0 ± 3.6% at 5 years. The percentages of patients with discontinuation of MTX due to sustained clinical response were 4.0 ± 2.3% at 1 year, 7.1 ± 3.1% at 2 years, and 18.7 ± 5.7% at 5 years.
This retrospective report comprises the largest North American, single-institution, case-control study evaluating the real-world efficacy and tolerability of MTX treatment in patients with GCA, to our knowledge. The results of our study demonstrate that patients with GCA treated with MTX have a nearly 2-fold reduction in relapse events after MTX initiation compared to patients treated with GC alone.
Clinical trials evaluating MTX in GCA have focused primarily on newly diagnosed patients11,12,13. While these trials demonstrated disparate results, limitations in the studies have included relatively short durations of followup, low MTX doses (7.5 mg to 15 mg/week), differing methods of steroid tapering, and small sample sizes. Indeed, among the 3 trials a combined total of only 84 patients received MTX compared to 77 patients receiving placebo. Although only 1 of the 3 trials13 reported significant benefit of MTX use, a metaanalysis of individual patient data from the 3 clinical trials did identify evidence that MTX reduced the risk of first relapse by 35% and second relapse by 51%14.
Based on the observed modest effect of MTX, some experts have recommended that MTX should be considered for use as adjunctive therapy in patients with large-vessel vasculitis4. Unfortunately, further guidance on the optimal patient subset, timing of initiation, dose, and duration were not outlined. Other expert consensus guidelines have suggested use of MTX in relapsing patients (3 or more relapses) or in patients who do not taper off GC5. However, investigation of MTX use in this specific subset of patients is limited to 2 small case series18,19. Leon and colleagues have recently reported an observational cohort of 168 patients with GCA; 65% were exposed to treatment with MTX, 50% of which were started within 1 month of diagnosis16. Overall, 31% of patients had a relapse during followup, and in multivariate analysis patients with GCA exposed to MTX had a 72% lower risk of relapse compared to those not exposed to MTX16. Unfortunately, information regarding relapse frequency prior to MTX was not included in the analysis.
In our current study, patients with high frequency of relapse benefited from initiation of adjunct MTX, with a 3-fold reduction in the frequency of relapses per 10 person-years. It is of note, however, that patients treated with only GC also had a reduction in relapse frequency over time. Nevertheless, the reduction in relapse rate in patients taking GC monotherapy was about 50% less than that observed in patients receiving MTX. Matching of patients receiving adjunct MTX (cases) to those receiving only GC (controls) was based on age, sex, duration of disease, and initial GC dose. It was not feasible to match based on number of observed relapses prior to MTX initiation/index date because the majority of patients treated with MTX had a substantially higher frequency of relapse compared to controls. A subset analysis evaluating the relapse rate reduction in cases and controls with 1+ relapses was attempted. This did not demonstrate a significant difference between the relapse rate reduction between cases and controls. However, it is of note that only 24 of the 83 controls had 1+ relapse and only 5 of 83 had 3+ relapses compared to 59 and 17 patients in the cases, respectively. Therefore, it is plausible that benefit of MTX in patients with GCA may occur predominantly among patients with increased risk and/or high observed frequency of relapse and MTX may not convey the same benefit to all patients affected by this condition.
Among patients in clinical trials, MTX use provided a higher probability of achieving sustained discontinuation of GC for > 24 weeks and also a modest reduction of GC exposure at weeks 48 (842 mg) and 96 (1101 mg). However, the onset of action of MTX in patients with GCA appeared to be delayed in conveying benefit because the superiority of MTX over placebo appeared only after 24–36 weeks of continued use14. In our current study, the ratio of patients achieving GC doses of ≤ 10 mg/day and GC discontinuation were similar among cases and controls. Although the reasons for such findings are unknown, given no standardized tapering regimen was used and clinicians tapered according to preference, it is possible that more cautious GC reductions were used because of the higher frequency of relapses observed among cases prior to MTX initiation. Other retrospective case series and cohort studies have not included information regarding GC tapering16,18,19, so it is unknown whether these findings reflect patient preference, physician bias, disease severity, or a combination thereof.
Overall, longterm use of MTX was tolerated in this patient population despite higher initial and maximum MTX doses compared to other studies11,12,13,20. At 5 years of followup, only 23% of patients had discontinued because of adverse drug event. Similar to the cohort described by Leon, et al15, the current cohort demonstrated that sustained clinical efficacy was the second most frequent cause of treatment discontinuation (18.7% at 5 yrs), and termination of MTX treatment for lack of efficacy was uncommon.
The results of the TCZ in GCA (GiACTA) study have demonstrated the superiority of IL-6 inhibition with an accelerated (26-week) GC taper compared to GC alone in the treatment of both newly diagnosed and relapsing patients with GCA10. While the results of this landmark study are significant, it is noteworthy that 23% of patients receiving weekly and 26% of patients receiving every other week TCZ still experienced a GCA flare during the study period. Treatment with MTX plus TCZ in patients with rheumatoid arthritis has been shown to be more effective than either drug in isolation21. It is unknown whether similar findings will be seen in patients with GCA, particularly those with relapsing disease. The GiACTA protocol allowed for patients taking MTX for > 6 weeks to continue on a stable dose during the study period, although only 17% of trial subjects were taking MTX22. Further subgroup analysis determining the potential role of adjunct MTX in patients with GCA receiving TCZ treatment is needed.
This study must be evaluated in the context of its limitations. First, and most importantly, the retrospective design limits abstracted data to information available in the medical record. Second, initiation and titration of MTX was not standardized and was at the discretion of the treating provider. The lack of standardization regarding which patients were chosen for MTX treatment affects the generalizability of these findings. Aside from higher relapsing rates prior to initiation of MTX, we did not observe a higher frequency of measured comorbidities or disease characteristics in patients treated with MTX. It is possible that unmeasured factors could have influenced the physician determination of MTX initiation, for which we could not control. However, given the lack of widely accepted consensus guidelines on the treatment of relapsing GCA, initiation of MTX based on provider preference in this cohort simulates real-world experience of GCA management. Third, patients in the MTX group had a higher starting dose of prednisone at MTX initiation/index date. While this was statistically significant, we do not consider the 4-mg higher dose at initiation and the average 2–3 mg/day higher dose annually to be responsible for the clinically significant relapse rate reduction. This is supported by the attenuated but still significant findings despite accounting for starting dose and GC use during followup. Fourth, the lack of standardized GC tapering prevents comprehensive analysis of GC-sparing effects. Because patients started on MTX had higher frequency of relapse prior to MTX initiation, it is possible that physician and/or patient preference regarding continuation of prednisone at low doses or with slower tapers may have contributed to ongoing use of GC, rather than tapering to discontinuation resulting in similar rates of achieving prednisone doses of < 10 mg/day for > 6 months and prednisone discontinuation > 6 months between cases and controls. Admittedly, we are not able to completely exclude the effect of chronic low-dose GC and their role in lowering relapse rates in this group; nevertheless, adjustment for GC use during followup after MTX initiation did not change the significance of the relapse rate reduction.
Our study has several strengths including its case-control design and longterm followup. In addition, compared to prior clinical studies, higher initial and maximal doses of MTX were used, reflecting real-world experiences with this medication. Further, to our knowledge this study comprises the largest North American cohort of relapsing patients with GCA treated with MTX described to date.
MTX is well tolerated in longterm use among patients with GCA. In addition, MTX can be considered as an adjunct medication in patients with a high frequency of flares and demonstrates benefit in reducing the rate of relapse. The utility of MTX plus TCZ in GCA is unknown, but information identifying the efficacy of this combination is anticipated.
APPENDIX 1.
Mean annual prednisone dose reduction following methotrexate initiation (cases) or index date (controls).
Accepted for publication October 10, 2018.
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Women's b-ball starts GLIAC
Neil Flavin: In a game from last season, junior guard Darby Youngstrom lines up, and releases a shot from the charity stripe. Last season, Youngstrom started all 29 games, totaling 885 minutes played.
Nate Bellville
Northern Michigan's Women's Basketball team concluded their season-opening seven road game trek with a 63-55 comeback win over the Bellarmine University Knights, but lost 59-49 to the University of Southern Indiana Screaming Eagles at the Bellarmine Tournament over Thanksgiving break.
Head coach Troy Mattson said that he was pleased on how the team survived their busy start to the season.
"I'm very proud of how the girls handled this whole month of November on the road and the amount of competition that we faced," Mattson said. "Through the weekend, we fought tooth-and-nail against two tough teams and I'm excited about that."
Sophomore Erin Honkala said the team had a good showing for the tournament.
"I thought we played really well. Though we suffered one loss, but I thought the weekend was successful," Honkala said.
On the 25th, a Wildcat slow start resulted in the Knights surging out front early. Falling behind 33-27 at halftime, NMU came out aggressive on offense. Junior guard Darby Youngstrom's five-point run lifted the Wildcats to the lead halfway through the third quarter. The teams swapped the lead back and forth with the hosts taking a 45-42 lead into the final frame.
The Wildcats' huge fourth quarter saw a seven straight point run to take the lead for good. Bellarmine would cut the lead down to one, but NMU outscored the Knights 21-10 to decide the game.
Youngstrom recorded 17 points for NMU, with freshman guard Elizabeth Lutz pitching in 15, and going three for four from the 3-point line. Honkala controlled the paint with 15 rebounds, eight points, six steals and five blocks.
On the 26th, Southern Indiana and NMU started the game battling for momentum as both teams swapped leads through the first two stanzas. Youngstrom and Honkala combined for 16 points between the two players as the Wildcats took a 24-22 halftime lead over the 17th-ranked Screaming Eagles.
The Eagles came out in the second half with strong shooting and rebounding to take a nine point lead into the fourth quarter. NMU attempted to make the game closer trailing by eight and with thoughts of an upset, but Southern Indiana put the game out of reach at 59-49.
"We probably played our best first half of basketball on defense against them. We made a couple of key mistakes in the third quarter, but Southern Indiana is a powerhouse team and I give them credit for that," Mattson said.
Honkala recorded a double-double (12 points, 12 rebounds) with Youngstrom adding 16 points in the game.
"Honestly, I didn't know I got it, but I'm excited about it," Honkala said on her double-double.
Junior guard Emily Schramek was happy about Honkala's achievement and improvement.
"Erin's been doing amazing, and it seems like every rebound was falling right to her arms," Schramek said.
NMU begins their home schedule with conference opponents (Northwood and Saginaw Valley) this weekend with the team yearning to finally play at home at the Berry Events
Schramek said she's eager to play stout competition on the home court, along with a family reunion on Saturday.
"We know that Saginaw Valley has lost two big players at the start and my sister plays for them too, so it'll be my first time playing her," Schramek said. "We don't know much about Northwood, but we're all excited to start conference play."
Mattson noted they're in a "three phase" season, which he said they're approaching their second phase of GLIAC play.
"To me, all records are 0-0," Mattson said. "We have matured well as a team and we're looking forward to the opportunity to play in our conference."
The Wildcats tip off their home schedule Thursday night against Northwood University Timberwolves and on Saturday against the Saginaw Valley State Cardinals.
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