Wednesday, November 5, 2008

Treating BD and other rheumatic diseases with rituximab (Rituxan)


Has your doctor suggested trying rituximab (Rituxan) for your Behcet's symptoms? Right now, it's only FDA-approved for treating non-Hodgkins lymphoma and rheumatoid arthritis (given in combination with methotrexate)
, but some doctors have been prescribing it off-label for Behcet's anyway.

So far, only one article has been published on the use of rituximab for Behcet's (to treat retinal vasculitis -- see below), but several case studies and research studies suggest that rituximab would probably be helpful for many autoimmune diseases in general. 685 rituximab clinical trials are currently registered at clinicaltrials.gov, but only eight of these studies deal with vasculitic diseases...and there's only one BD study listed.

I'm not medically trained, and can't offer advice on whether or not to try rituximab. That's between you and your doctor. Like many of the newer drugs on the market, though, it has the potential for some very serious side effects. Make sure you understand all of these side effects before agreeing to take it. For some of us, a better quality of life may be worth the risk.

Your insurance may or may not cover rituximab, and it's an expensive drug. I've read online that it can cost upwards of $14,000 for two treatments, although I don't have that information first-hand.

Some of the following articles are available online for free, and some only offer the abstract (or nothing at all except the reference) -- you'd have to buy the full article, or go to a medical library to get a copy, or ask your doctor to get it.


Treatment of retinal vasculitis in Behcet’s disease with rituximab
(with free preview of the first page of the article)
Mod Rheumatol (2008) 18:306–308
DOI 10.1007/s10165-008-0057-9
S. Sadreddini, H. Noshad
Tabriz University of Medical Sciences, Golgasht St., 51664 Tabriz, Iran
Excerpt from the abstract:
Up to now, there are some problems in treatment of the retinal vasculitis due to Behcet’s disease. We reported one patient, with visual loss due to retinal vasculitis that was resistant to prednisolone and azathioprine. Our patient was treated successfully with rituximab and his remission was sustained for 24 months of follow-up.
It is very difficult to assess the efficacy [effectiveness] of rituximab on Behcet’s disease due to the variation in treatment regimens and heterogeneity of [differences between] the few studied patients. This is among the first reports about the treatment of retinal vasculitis in Behcet’s disease with rituximab. Treatment with this drug led, in our patient, to a complete remission of ocular inflammatory manifestations and there was no relapse after the steroid tapering period. Although such reports are promising, further studies are required to evaluate the efficacy of rituximab in ocular Behcet’s disease, especially in retinal vasculitis.

Rituximab in autoimmune diseases: off-label use in clinical practice
Medscape Medical News
Janis Kelley, January 2005

Off-label use of rituximab in hospitals [in Australia]. March 2007.
Available in full online, 30 pages.


Safety of Biologic Therapy in Rheumatoid Arthritis and Other Autoimmune Diseases: Focus on Rituximab
Seminars in Arthritis and Rheumatism, In Press, Corrected Proof, Available online 12 March 2008, Roy M. Fleischmann. doi:10.1016/j.semarthrit.2008.01.001
Excerpt from the abstract:
Rituximab is approved for treating RA [rheumatoid arthritis] in patients with an inadequate response to TNF inhibitors and is under study in other indications for RA and other autoimmune disorders. The current safety profile of rituximab in RA is known from Phase II and III studies conducted pre-approval, treating approximately 750 patients, as well as from long-term extension studies with repeated therapy. Clinical trials have established that the most common adverse events [side effects] are infusion-associated reactions, seen in 29 to 40% of patients, most of which are mild to moderate and occur following the first rituximab infusion, with incidence and severity decreasing with subsequent infusions. Rates of infections and serious infections to date are within the range expected for RA patients treated with other biologic agents, but the longer term effects of B-cell depletion and the effects of repeated treatment on the risk of infections are uncertain. Information is limited for rituximab safety in other autoimmune disorders but current data do not suggest that there is a significant difference in adverse events from that previously reported.

Article appears in full online, for free
Skin Therapy Lett. 2007 Jul-Aug;12(6):6-9. Review. V. Prajapati; P. R. Mydlarski, MD, FRCPC Division of Dermatology, Department of Medicine, University of Calgary, Calgary, AB, Canada

Tolerance and short term efficacy of rituximab in 43 patients with systemic autoimmune diseases.
Full article available online for free

Ann Rheum Dis 64:913–920
Gottenberg JE et al (2005)
Excerpt from the abstract:
Conclusions: Despite absence of marketing authorisation, rituximab is used to treat various refractory autoimmune diseases [autoimmune diseases that don't respond to other drugs]. in daily rheumatological practice. This study showed good tolerance and short-term clinical efficacy [effectiveness], with marked corticosteroid reduction in patients with SLE, pSS, vasculitis, and polymyositis.

Rituximab Off Label Use for Difficult-To-Treat Auto-Immune Diseases: Reappraisal of Benefits and Risks
Clinic Rev Allerg Immunol (2008) 34:103–110
Sailler, L.
DOI 10.1007/s12016-007-8020-7
Diseases covered in the article include: Wegener's granulomatosis, HCV-associated symptomatic cryoglobulinemia in patients unresponsive to anti-viral therapy, pemphigus, lupus, refractory immune thrombocytopenic purpura (ITP), dermatomyositis-polymyositis, ANCA-positive vasculitis, and primary sicca syndrome patients.

Should Rituximab be Considered as the First-Choice Treatment for Severe Autoimmune Rheumatic Diseases?
Clin Rev Allergy Immunol. 2008 Feb;34(1):124-8.PMID: 18270866
Galarz C,
Valencia D, et. al.
Excerpt from the abstract:
Forty-three patients had systemic lupus erythematosus (SLE), 21 had rheumatoid arthritis (RA), 8 had Sjögren's syndrome (SS), and 2 had Takayasu's arteritis (TA). RTX [rituximab] was well-tolerated in 66 (89%) patients. In 8 patients (SLE = 3, SS = 3, RA = 2), serious side effects lead to discontinuation. The mean follow-up period was 12 +/- 7.8 (2-35) months. The efficacy of RTX was registered in 58/66 (87%) patients, of whom 36 (83%) had SLE, 18/21 (85%) had RA, 3/8 (37%) had SS, and 1 had TA. The mean time of efficacy was 6.3 +/- 5.1 weeks. A significant steroid-sparing effect was noticed in half of the patients. These results add further evidence for the use of RTX in AIRD [autoimmune rheumatic disease]. Based on its risk-benefit ratio, RTX might be used as the first-choice treatment for patients with severe AIRD.

Rituximab in rheumatic diseases
Joint Bone Spine. 2007 Jan;74(1):4-6
Saraux A, Devauchelle V, Jousse S, Youinou P.
There is no abstract available online. Speak with your doctor about getting a copy of this article.

Here is some information on the use and side effects of rituximab. Even though drugs like rituximab can be very helpful, they also have the potential to cause some very serious health issues -- make sure you know all of them before agreeing to take this (or any other) medication:
http://www.rxlist.com/rituxan-drug.htm
Mayo Clinic also has a good list of side effects
MedlinePlus information on rituximab

Information written by a non-Behcet's patient, on how to prepare for your first treatment with Rituxan

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