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14 Arthritis R HEUMATOLOGY N EWS • May 2005 TNF Blockers Linked to Severe Skin Reactions

Overall, 25% of patients taking the biologics had a Among the patients taking anti-TNF ther- Eczema was diagnosed 20 times in 19 apy, 70 (24%) had received more than one patients, and 3 patients stopped therapy as dermatologic event compared with 13% of controls. agent, 8 (3%) had a history of taking a result. One patient was hospitalized. more than two. The others were treated with topical cor- BY ALICIA AULT In the trial, 289 consecutive patients Overall, 167 patients were given inflix- ticosteroids. Contributing Writer with RA who were started on TNF- imab, 108 received , 78 re- There were frequent cases of drug-re- –blocking therapy—, etaner- ceived , and 31 were treated lated eruptions in the first 5 months, in kin reactions to tumor necrosis fac- cept, adalimumab, or the experimental with lenercept. In total, there were 128 particular, said the authors. tor-–blocking drugs for rheumatoid agent lenercept—were compared with 289 dermatologic events in the TNF group; 56 Most common was a combination of Sarthritis might be more common and patients from a cohort of 500 who have events occurred with adalimumab, 49 exanthema, urticarial eruptions, lichenoid more varied than previous studies have in- skin lesions, and purpura. Of 15 patients di- dicated, results of a new prospective study agnosed with an eruption, 7 stopped ther- show. apy, and 8 continued. One patient was hos- The study authors, led by Marcel Flen- ARCEL pitalized. . M R

drie, M.D., of Radboud University Ni- D In smaller numbers, patients also expe- jmegen (the Netherlands) Medical Centre, rienced ulcers, benign and malignant skin said theirs is the first large prospective tumors, vasculitis, actinic keratosis, ede- study of dermatologic conditions in ma, chronic venous insufficiency/varices, (RA) patients taking xerosis cutis, and stasis dermatitis. HOTOS COURTESY LENDRIE

TNF-–blocking medications. P F The occurrence of psoriasiform erup- Overall, 25% of the 289 patients taking An eczematous reaction on the left arm A similar eruption occurred on the right tions in three patients was “particularly in- the biologics had a dermatologic event, of an RA patient on infliximab is shown. leg of the same patient. teresting,” given that etanercept is approved compared with 13% of the same number for psoriasis, and infliximab may soon get of control patients. been followed at the medical center since with infliximab, 16 with etanercept, and that approval, the researchers said. The odds ratio for a patient taking the 1985 but who had never taken a TNF- 13 with lenercept. The time between the start of therapy biologics to require a dermatologic refer- –blocking agent. Skin infections accounted for the and onset of skin conditions varied, but ral was 2.26 (Arthritis Res. Ther. Any patient who visited a dermatologist largest proportion of these therapy-re- some events looked more likely to be 2005;7:R666-76). The study was published during the follow-up period was identified, lated events, with 33 fungal, bacterial, and drug related, including the eruptions, cu- online at BioMed Central’s Web site on and any new manifestation or exacerbation viral infections recorded. TNF-–block- taneous vasculitis, a case of systemic April 4 (www.arthritis-research.com/con- of a skin disease or any drug-related erup- ing therapies are known to increase sus- erythematosus, dermatomyositis, and a tent/7/3/r666). tions were recorded. The researchers also ceptibility to infections, and the study lymphomatoid papulosis-like eruption, the There seemed to be no characteristic at recorded diagnoses, topical and systemic findings suggest that the immunosup- authors continued. baseline that predicted which patients therapeutic actions, outcome of the event, pressive agents might also make patients Overall, 19 of the 72 patients who ex- might be susceptible to a dermatologic and any information on rechallenge. more vulnerable to skin infections, said perienced skin problems stopped taking event, the authors said. Median follow-up time was 2.3 years. the authors. the TNF-–blocking therapy. I Belimumab, Are Next in the Biologic Pipeline for RA

BY PATRICE WENDLING TNF- inhibitor and up to 10 mg/day of Long-term Efficacy of Rituximab in RA Stanley B. Cohen, M.D., the principal in- Chicago Bureau . (REFLEX) trial showed that a greater pro- vestigator for the Radiant Research site of About 73% of patients were receiving portion of rituximab-treated patients the trial. C HICAGO — A host of promising new background . More than achieved an ACR 20 at week 24 than those The findings so far support the hypoth- therapies for rheumatoid arthritis are in one-third of patients (38%) had been failed taking , said Dr. Genovese, also a esis that “we have a potential therapy that development, including the mon- by at least one TNF- inhibitor. consultant for Genentech Inc., which we can use in patients with disease that is oclonal belimumab, Mark C. Patients were randomized to receive sponsored the study. refractory to our most potent therapies to Genovese, M.D., reported at a sympo- placebo or belimumab in doses of 1 The study included patients with active date, which are TNF inhibitors,” Dr. Co- sium sponsored by the American College mg/kg, 4 mg/kg, or 10 mg/kg, given in- RA who had an inadequate response or hen said in an interview. of Rheumatology. travenously for 24 weeks. were intolerant to prior treatment with Detailed results from REFLEX are ex- Belimumab inhibits the activity of B- All patients were dosed on days 0, 14, one or more anti-TNF therapies. pected to be presented at the annual con- lymphocyte stimulator (BLyS), a and 28, then every 28 days for the re- The data did not show anything unex- gress of the European League Against that is elevated in the blood and joint flu- mainder of the 24 weeks. pected regarding safety or efficacy, said Rheumatism in June. I id of people who have rheumatoid arthri- The study’s primary efficacy end point tis (RA). was the achievement of an American Col- DATA W ATCH BLyS is believed to contribute to the lege of Rheumatology (ACR) 20 response production of autoantibodies, especially at 24 weeks. Racial Differences Among Adults Diagnosed With Arthritis rheumatoid factor, which appears to cor- Among those in the 1-mg/kg group, relate with disease severity. 36% achieved an ACR 20 response, as did An interim analysis of a phase II trial of 17% in the placebo group. This between- Black Hispanic White belimumab (LymphoStat-B) showed a clin- group difference was statistically signifi- ical effect at various doses in 283 patients cant. 44.2% with active moderate to severe RA, said Trends toward a drug benefit were seen 39.7% 39.5% 38.8% Dr. Genovese, an investigator for Human in the 4-mg/kg group (28% ACR 20) and 34.1% 34.0% Genome Sciences, which sponsored the in the 10-mg/kg group (29% ACR 20). 32.5% study. Adverse events were similar across treat- 28.0%

Belimumab also produced statistically ment groups, and clinically significant in- 22.6% ESIGN significant reductions in all active treat- fusion reactions were rare, according to a ,D IES ment groups of circulating B cells (CD statement by Human Genome Sciences. R 20+ and other subsets) and rheumatoid Another promising therapy, rituximab, NGIE factor, compared with placebo. is a that targets /A “It’s an encouraging therapy,” Dr. Gen- CD20 on B cells, said Dr. Genovese, chief

ovese told this newspaper. “But that en- of clinical services in the division of im- ESEARCH Activity limitations Work limitations Joint pain in preceding 30 days thusiasm has to be tempered by the fact munology and rheumatology at Stanford ,R we have to see more studies.” University, Palo Alto, Calif. OLEY

Note: Definition of arthritis includes rheumatoid arthritis, gout, lupus, or fibromyalgia. F Patients were allowed concurrent stan- A preliminary analysis of phase III data Source: 2002 data, Centers for Disease Control and Prevention EVIN dard-of-care therapy, including at least one from the Randomized Evaluation of K