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RHEUMATOLOGIC DISORDERS Arthur
A. Schuna, Section Advisor
Registry data indicate rituximab safe and effective for SLE
Key point: A prospective analysis of the French
Autoimmunity and Rituximab (AIR) registry showed that rituximab
(Rituxan—Genentech; Biogen Idec) was satisfactorily tolerated and
had clinical efficacy in systemic lupus erythematosus (SLE) patients.
Efficacy results from the AIR registry are similar to data analyses from
open-label trials, but contrary to analyses from randomized,
placebo-controlled trials.
Finer points: Benjamin Terrier, MD, and colleagues
conducted a prospective analysis of data from patients with SLE enrolled
in the French AIR registry. The analysis included 136 patients with SLE
from 44 centers who received rituximab from September 2005 to June 2009.
Disease severity was assessed using mean baseline Safety of Estrogens in
Lupus Erythematosus National Assessment (SELENA)–SLE Disease
Activity Index (SLEDAI); other endpoints included at least 50%
improvement or resolution of cutaneous and articular disease
manifestations as determined by the clinician in charge. In all, 113
patients reached the 3-month visit minimum to be included in the
efficacy analysis. Mean duration of follow-up was 18.6 months, and only
0.7% of patients were lost to follow-up. Overall response after
rituximab treatment was observed in 71% (80/113) of patients using the
SLEDAI assessment (as indicated by a decrease in SLEDAI by at least 3)
and in 77% (87/113) of patients according to the evaluation by the
clinician in charge. Overall response was not significantly different
between patients receiving rituximab monotherapy or combina-tion therapy
with immunosuppressive agents. The mean prednisone dosage decreased from
30.3 ± 23.6 mg at baseline to 12.3 ± 10 mg/d after 6 ± 3
months (P < 0.001). A relapse was observed in 31 of 76
responders after 6 months of rituximab use; 25 of these 31 patients
received rituximab retreatment and a response was observed in 20 of 22
evaluable patients. Severe infusion reactions (anaphylaxis and
hypotension), serum sickness-like reactions, and severe infections were
reported in 2, 5, and 12 patients, respectively. Death from severe
infection was observed in 5 patients. Terrier et al. concluded that
rituximab demonstrated good clinical efficacy, a corticosteroid sparing
effect, and a satisfactory tolerance profile.
What you need to know: Rituximab for the treatment
of SLE is controversial. Data from open-label trials have shown efficacy
with rituximab treatment; however, two randomized, controlled trials
failed to meet their primary endpoints. The methods of evaluating
efficacy used by Terrier et al. (clinician assessment of improvement and
SLEDAI), while practical, may be subjective and therefore inaccurate.
Editorialists commented that the differences in results between AIR and
the randomized, controlled trials could be attributed to the rigor,
complexity, and breadth of the different endpoints that were measured to
assess clinical efficacy in each type of trial.
What your patients need to know: Tell patients with
SLE that rituximab has been shown to be effective in open-label and
observational trials, but not in controlled clinical trials. Additional
controlled trials may help identify which SLE patients benefit from
rituximab treatment. Encourage patients who are not responding to
conventional SLE therapies to discuss their treatment options with their
prescribing physician.
Sources:
Posted by Alex Egervary (aegervary@aphanet.org)
July 6, 2010, 9:15 am
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