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."
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.
Labels: book review, books, drugs, enbrel, humira, remicade, tnf
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.
The Salisbury Journal has another one of those articles about an ankylosing spondylitis patient who, having taken Remicade (infliximab), has made a dramatic turnaround: "After I had the treatment, I was out of the hospital like an athlete, I was told it could take several weeks to work but it was amazing and worked straight away," the article quotes the unfortunately named Mark Weakly. "It's like a miracle cure."
As you may know, I've seen a lot of stories like these in the British press.
British Columbia's provincial drug plan doesn't cover Remicade (infliximab) for ankylosing spondylitis, though it's been approved for rheumatoid arthritis and Crohn's disease, reports The Peace Arch News, leaving AS sufferers (or, presumably, their private plans) to pick up the full $24,000 tab if they want the newer treatment.
One interesting bit from the article encapsulates the problem with B.C.'s prescription drug coverage: "B.C. pays more for generic drugs than other provinces; and, B.C. is usually last to approve new medications. One drug, Enbrel, for the treatment of psoriatic arthritis, has been under study and review here for more than three years. Meanwhile, it’s approved for use in every other province except Prince Edward Island." Of course, Enbrel (etanercept) is of interest to AS sufferers too.
Ankylose This! is a group blog about life with ankylosing spondylitis. Its authors post about their own experiences, medical news, and useful resources.
Disclaimer: None of us are doctors, and nothing in this blog should be construed as medical advice. We are simply patients trying to make sense of our disease.
