Ankylose This!

B.C. drug plan to cover TNF drugs for AS

noreply@blogger.com (mcwetboy) — Sat, 08 Mar 2008 04:48:54 -0600

The Vancouver Sun reports that British Columbia's provincial prescription drug plan will cover adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade) for patients with ankylosing spondylitis who meet the criteria of the plan's Special Authority program.

Update, March 8: Reaction from the Arthritis Society, which says that they and others have been lobbying the government for this decision for years.

Quack cures for arthritis

noreply@blogger.com (mcwetboy) — Sun, 02 Mar 2008 18:51:51 -0600

About.com: How to spot a quack cure for arthritis.

Saskatchewan approves Enbrel, Humira for AS

noreply@blogger.com (mcwetboy) — Thu, 21 Feb 2008 19:12:45 -0600

Amazing what a change of government does. Saskatchewan's provincial drug plan now covers Enbrel and Humira for ankylosing spondylitis under Exception Drug Status coverage.

Update: CBC News coverage. Remicade wasn't approved because it costs more.

Previously: More about Saskatchewan's TNF coverage; Saskatchewan to AS patients: No biologics for you!

ACE demands biologics coverage for Aboriginal Canadians

noreply@blogger.com (mcwetboy) — Fri, 15 Feb 2008 21:09:10 -0600

Fresh from going after Saskatchewan for its refusal to cover biologics for AS, Arthritis Consumer Experts is now turning its attention to the drug coverage provided to Aboriginal Canadians by the Non-Insured Health Benefits program of Health Canada's First Nations and Inuit Health Branch. Noted without comment -- I'm presently working on contract at Health Canada.

More about Saskatchewan's TNF coverage

noreply@blogger.com (mcwetboy) — Sat, 26 Jan 2008 08:29:55 -0600

A follow-up article from the Regina Leader-Post on Saskatchewan's coverage of biologics -- they're covered for rheumatoid arthritis, two out of three are for psoriatic arthritis, but none for ankylosing spondylitis -- suggests, as an aside, that the newly elected Saskatchewan Party government may reverse the earlier decision not to approve coverage for AS. Indeed: why should our disease be treated, pun intended, differently?

Previously: Saskatchewan to AS patients: No biologics for you!

Living with arthritis

noreply@blogger.com (mcwetboy) — Sat, 12 Jan 2008 06:00:16 -0600

Ida Weibel's personal essay for Newsweek's Web site, Living with Arthritis, is a must-read: even though she' spent 10 years living with rheumatoid arthritis and not ankylosing spondylitis, anyone with a chronic debilitating illness will recognize her experience. This passage, for example, is just as relevant to us:

When RA patients complain about their illness, few understand or acknowledge their suffering. Every adult has experienced a painful elbow, knee, finger, or some other joint that interferes with physical activities. But people can be dismissive of our chronic problems because RA isn't life-threatening and may seem less serious than some other diseases. Those with rheumatoid arthritis, especially those with severe symptoms, are often silent and solitary sufferers.

Via About.com Arthritis.

Europe approves broader use of Remicade for AS

noreply@blogger.com (mcwetboy) — Sat, 12 Jan 2008 05:52:27 -0600

Label enhancements for infliximab (Remicade) have been approved by the European Commission for ankylosing spondylitis, Crohn's, and psoriatic arthritis, according to a press release: "The ankylosing spondylitis (AS) label indication has been broadened to include adults with severe active AS who have responded inadequately to conventional therapy. The label also includes a significant improvement in physical function and quality of life."

Nor New Zealand

noreply@blogger.com (mcwetboy) — Thu, 03 Jan 2008 14:40:29 -0600

Pharmac, New Zealand's state pharmaceutical plan, covers TNF inhibitors for rheumatoid arthritis, but not for ankylosing spondylitis or psoriatic arthritis. On its face, this looks less like pushback against the high cost of TNF blockers and more like taking a long time to approve it for diseases other than rheumatoid arthritis (which is usually the first disease these things get approved for).

Alberta won't cover biologics either

noreply@blogger.com (mcwetboy) — Sat, 22 Dec 2007 20:45:24 -0600

It's not just Saskatchewan: Alberta's public drug insurance plan refuses to cover biologics for the treatment of ankylosing spondylitis, the Calgary Herald reports. The issue forming up is the need to keep skyrocketing drug expenses under control versus the need to provide effective treatments for crippling, chronic illnesses. (It occurs to me that if a $15,000-a-year treatment is the difference between someone working and not working, it's money well spent.) In a letter to the editor, Ken Mulholland argues, "I realize that these drugs are very expensive, but how is it that provinces like Ontario and Quebec have approved their use while Alberta, with all of its wealth, can flatly deny sufferers within its borders?"

Saskatchewan to AS patients: No biologics for you!

noreply@blogger.com (mcwetboy) — Sat, 26 Jan 2008 08:30:47 -0600

Meanwhile, a Canadian arthritis lobby group is fulminating against the Saskatchewan government, which last month decided against listing three TNF blockers -- presumably the big three, Enbrel, Humira and Remicade -- for the treatment of ankylosing spondylitis. This isn't about prescription drug coverage, says the group; it's about access, pure and simple: "As a result, people living in Saskatchewan with this inflammatory disease have absolutely no access to biologic medications to manage their disease." That seems a bit much. No access at all?

Update, 11/15: CBC News has more, including the Saskatchewan Formulary Committee's rationale: their position is that "the clinical benefit does not justify the incremental cost of these drugs." As a result of last week's provincial election, there will shortly be a change of government in Saskatchewan, so this decision may well be reversed.

Update, 11/18: More coverage from the province's main newspapers.

Humira and uveitis

noreply@blogger.com (mcwetboy) — Tue, 13 Nov 2007 15:00:24 -0600

Researchers from the RHAPSODY study, which is examining the efficacy of adalimumab (Humira) on ankylosing spondylitis, report that the incidence of uveitis is markedly reduced among patients receiving the anti-TNF treatment.

NICE to AS patients: No Remicade for you!

noreply@blogger.com (mcwetboy) — Mon, 12 Nov 2007 09:43:03 -0600

Britain's National Institute for Health and Clinical Excellence (NICE) has made a decision that restricts access to anti-TNF therapy by patients with severe ankylosing spondylitis, and the National Ankylosing Spondylitis Society (NASS) isn't happy about it. Only two out of three biologics will be accepted for use against ankylosing spondylitis: etanercept (Enbrel) and adalimumab (Humira), but not infliximab (Remicade). And Enbrel and Humira cannot be used sequentially -- which is to say that if you try Enbrel and it doesn't work, you can't then try Humira. And if neither works, you're SOL for Remicade. Cost is being cited: Remicade is more expensive to administer (since it can't be self-injected). See coverage from Channel 4, the Daily Mail, and This Is London.

As anyone with chronic inflammatory arthritis will tell you, it's impossible to tell what treatment will work in advance: I'm on naproxen, but I know AS patients who can't tolerate it; I know people who use indomethacin, but couldn't handle it myself. To have only one shot at anti-TNF therapy may make sense from a cost perspective, but it's lousy from the perspective of the person actually suffering from the disease.

Golimumab and ankylosing spondylitis

noreply@blogger.com (mcwetboy) — Sun, 11 Nov 2007 19:55:00 -0600

Golimumab: another TNF-alpha antagonist for us to keep track of (I wonder what the trade name will be). According to a press release, "More than half of patients receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) 50 mg and 100 mg experienced significant and sustained improvements in the signs and symptoms of active ankylosing spondylitis, according to Phase 3 study results presented at the American College of Rheumatology (ACR) annual meeting."

At some point there will be as many biologics at our disposal as there currently are NSAIDs. Not that they'll be as cheap.

Researchers implicate two genes in development of AS

noreply@blogger.com (mcwetboy) — Sun, 21 Oct 2007 20:58:01 -0500

In what is being called a major genetic breakthrough, researchers have identified a relationship between two genes and the development of ankylosing spondylitis. Their research was published in Nature: Genetics today. From the media release: "The researchers have identified two genes, ARTS1 and IL23R, which increase the risk of developing the disease. Together with the genetic variant HLA-B27, this takes the number of genes definitely known to be involved in the disease to three. A person carrying all three variants would be expected to have a one in four chance of developing the disease."

But wait, there's more. The IL23R gene has already been implicated in Crohn's disease, which we already knew was closely related to AS. From the media release again, quoting Queensland University professor Matthew Brown: "'We already know that IL23R is involved in inflammation, but no one had ever thought it was involved in ankylosing spondylitis,' says Professor Brown. 'A treatment for Crohn's disease that inhibits the activity of this gene is already undergoing human trials. This looks very promising as a potential treatment for ankylosing spondylitis.'" So already there are therapeutic implications: interesting.

TNF antagonists and skin cancer

noreply@blogger.com (mcwetboy) — Wed, 29 Aug 2007 20:28:44 -0500

According to a study published in Arthritis and Rheumatism (abstract), TNF therapy is associated with an increased risk of skin cancer. The study examined 13,001 rheumatoid arthritis patients in clinical trials and compared their cancer rates with the general public. Via About.com Arthritis.

Review: Arthritis Without Pain

noreply@blogger.com (mcwetboy) — Sun, 26 Aug 2007 10:29:57 -0500

Arthritis Without Pain: The Miracle of TNF Blockers
by Scott J. Zashin, M.D. with M. Laurette Hesser
Rev. ed. Sarah Allison Publishing Company, 2004. Softcover, xiv + 261 pp. ISBN 0-9754060-0-0

Of the new TNF-alpha antagonists -- principally etanercept (Enbrel), infliximab (Remicade) and adalimumab (Humira) -- that have generated so much attention in recent years and that have promised a revolution in the treatment of arthritic conditions, three things can be said. One, they're extremely expensive, costing thousands if not tens of thousands of dollars a year to administer. Two, they've been the subject of an intense marketing and media campaign on their behalf by the pharmaceutical companies, by doctors, and by advocates, who want as many people taking these new treatments and as many prescription drug plans covering them as possible. And three, from all accounts, they really do work.

The cost makes me blench, and the marketing makes me nervous. But there's a rationale behind both, and that is that these treatments are unlike anything else that we've taken before. They are far more complex to manufacture than traditional drugs, and they cannot be taken orally -- the digestive system would destroy the proteins before they hit the bloodstream -- and so must be administered by infusion or injection. They are, in other words, qualitatively different from any other arthritis treatment out there, and considerable explanation is therefore required.

There is therefore ample justification for a book such as Arthritis Without Pain: The Miracle of TNF Blockers, written by rheumatologist Scott J. Zashin with M. Laurette Hesser. While it suffers from the breathless "miracle-cure" rhetoric that I've seen before and that sets off my internal alarms, it does a respectable job of explaining what these treatments are, how they work, and how they fit in with other arthritis treatments out there. The detail is considerable, from how these treatments are administered, to how long they may take to take effect. And, to be sure, their potential side effects and drawbacks are mentioned as well.

Arthritis Without Pain was first published in 2000; this is the revised 2004 edition. But events have already overtaken things somewhat: Enbrel and Humira have since been approved for ankylosing spondylitis, for example. And it's primarily a book for people with rheumatoid arthritis; those of us with other rheumatic conditions for which these treatments are (now) indicated may be a little disappointed with that focus.

Another shortcoming too obvious to me as a copyeditor, but that most of you couldn't care less about: the book could frankly have been better written and better proofread. (Page 6: "More than 23 million Americans have [osteoarthritis]. Over one-third are women." Why that's more significant than the nearly two-thirds that are, presumably, men I have no idea.)

And is it truly necessary to use the ® symbol in every instance of a trade name? Style guides would not indicate so. But the fact that Zashin and Hessler cannot talk about Enbrel and Remicade, but only Enbrel® and Remicade®, may have something to do with the fact that Zashin has worked as a paid consultant for the companies involved. I would be more comfortable with reports about TNF antagonists that came from sources not so closely affiliated with the companies who made them.

Hydrotherapy pool closure affects AS patients

noreply@blogger.com (mcwetboy) — Fri, 03 Aug 2007 11:35:14 -0500

The closure of the hydrotherapy pools at Southampton General Hospital due to staffing shortages has drawn a stiff complaint from the director of the National Ankylosing Spondylitis Society: Jane Skerrett argues that hydrotherapy pools make "a major contribution to people living with this disease." The Southampton pools have been closed for two months.

Newcastle AS study

noreply@blogger.com (mcwetboy) — Fri, 03 Aug 2007 11:36:09 -0500

A Newcastle University researcher is carrying out a study on young people with ankylosing spondylitis; "[p]atients with ankylosing spondylitis (AS) who attend the Freeman and North Tyneside Hospitals in Newcastle, Queen Elizabeth Hospital in Gateshead, and Wansbeck Hospital in Ashington will be asked to participate." The story is vague about the parameters of the study, but it appears that education is at least one focus.

People with AS in the news

noreply@blogger.com (mcwetboy) — Thu, 02 Aug 2007 10:25:06 -0500

Boston Globe: Ellyn Robinson, a 42-year-old associate professor of exercise physiology who runs marathons and triathlons, is also a competitive weightlifter: she competes this month at the World Masters championship in Hungary. She was diagnosed with ankylosing spondylitis in 2000.

Willoughby News-Herald: 22-year-old Hilary Petersen of Mentor, Ohio ran a five-mile race only a year after being diagnosed with AS (see also).

Newham Recorder: Danny Branham, 49, is the latest persion with AS whose prognosis improved dramatically after being injected with TNF blockers to be featured by the British media.

Montgomery County Sentinel: Despite diagnoses of ankylosing spondylitis and sarcoidosis, Deserie Johnson, 36, still managed to put out a CD of beat poetry.

It's in the family

noreply@blogger.com (mcwetboy) — Mon, 30 Jul 2007 20:26:55 -0500

We've known for a while that ankylosing spondylitis and its related illnesses tend to run in families. In my case, my grandfather -- who turns 91 next month -- had AS as well, and an uncle had Crohn's disease. A recent study turned to Iceland -- and its small, homogenous population and extensive genealogical database -- to quantify the risk of contracting AS or inflammatory bowel disease if a close relative has it as well.

First-, second-, and third-degree relatives of patients with AS had risk ratios of 94, 25, and 3.5, respectively, indicating an increased risk of developing AS, while first-, second-, and third-degree relatives of patients with IBD had risk ratios for IBD of 4.4, 2.2, and 1.4, respectively. In addition to confirming the genetic risk for AS and IBD independently, the study found elevated cross-risk ratios between IBD and AS in both first- and second-degree relatives. The cross-risk ratios for IBD in first- and second-degree relatives of patients with AS were 3.0 and 2.1, respectively, and, notably, were the very same for AS in first- and second-degree relatives of patients with IBD. Overwhelmingly, findings applied to blood relatives.

Wellcome Trust images

noreply@blogger.com (mcwetboy) — Mon, 09 Jul 2007 09:02:10 -0500

The Wellcome Trust's library of historical and contemporary medical images was recently made freely available under a Creative Commons licence; a search for "ankylosing spondylitis" reveals 32 results, mostly X-rays and internal imagery. Via Boing Boing.

Bryan Gunn

noreply@blogger.com (mcwetboy) — Sat, 23 Jun 2007 10:13:35 -0500

A profile of Bryan Gunn, who, despite being diagnosed with ankylosing spondylitis at age 28, continued to play football/soccer for the Norwich City Football Club until he was 35.

Results of two-year clinical trial reported

noreply@blogger.com (mcwetboy) — Fri, 15 Jun 2007 09:01:38 -0500

During a two-year clinical trial, the results of which were announced today, ankylosing spondylitis patients taking Remicade (infliximab) "experienced significant improvement in spinal mobility ... [and] showed sustained reductions in spinal inflammation through two years as detected by magnetic resonance imaging." The ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial involved 279 patients, 78 of whom received a placebo. I'm assuming this is a company-sponsored study.

Referred pain

noreply@blogger.com (mcwetboy) — Thu, 14 Jun 2007 07:38:34 -0500

This post about referred arthritis pain takes me back: after I came down with the symptoms of AS, but before I was diagnosed with it, I complained about pain in the neck and shoulders. But the bone scan revealed severe sacroilitis -- inflammation of the sacroiliac (pelvic) joint. My doctor asked why I didn't report on that -- I was too preoccupied with the neck, shoulder and upper back pain, which was keeping me from sleeping. The sacroilitis, to be sure, was keeping me from walking properly, but it seemed a secondary thing. Also, after several months of sleep deprivation I wasn't thinking too clearly.

Pharmaceutical triage in the UK

noreply@blogger.com (mcwetboy) — Wed, 13 Jun 2007 17:33:35 -0500

We've heard before about the difficulties British ankylosing spondylitis patients have had trying to get coverage for the latest (and presumably greatest) treatments, the expensive TNF-alpha blockers. This BBC News article affords some insight into the process by which an individual patient can have such treatments approved -- or denied:

The first business is two requests from patients with a painful rheumatic disease, ankylosing spondylitis.

They want drugs which cost £11,000 a year, but haven't yet been given the seal of approval by the health watchdog, the National Institute for Health and Clinical Excellence (NICE).

Other local patients might be eligible -- so the question is: are these exceptional cases?

"For a PCT our size, I guess we're looking at anywhere between 250 and 500 cases who may potentially benefit from this drug," said the public health director.

Another panel member said: "The doctor who's presented this says the severity of this patient's symptoms is unusual -- but that's not the same as exceptional.

"I guess for me it's the uncertainty about how this drug will affect this patient. Funding it would be a speculative move -- given the evidence we've got here."

Both requests are turned down.

It's worth noting that biologics are usually indicated when more conventional treatments are ineffective. The whole lot of us aren't going on Remicade, and many of us, I suspect in my limited and unqualified way, won't ever need to.

Previously: Postcode lottery for TNF-alpha in the UK; AS and prescription drugs in Scotland.