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Safety of combination therapy with rituximab and etanercept for patients with rheumatoid arthritis.

Safety of combination therapy with rituximab and etanercept for patients with rheumatoid arthritis SIR, Treatment of RA with rituximab (RTX) is established for patients with an inadequate response to anti-TNF-therapy [1–3]. Previous RTX trials show an ACR-70 response in $15% of all patients after 24 weeks [2, 3]. Therefore, a significant fraction of RA patients cannot be treated sufficiently. Other trials showed that combinations of etanercept (ETN) and anakinra [4] or ETN and abatacept [5] were associated with severe infections and are not recommended. Current guidelines propose that patients with an inadequate response to one or more anti-TNF-drugs should switch to RTX therapy [6]. Recently published data suggest a switch to RTX after inefficacy of the first anti-TNF-drug [7]. Current practice for switching to RTX is to discontinue ETN for 2 weeks, adalimumab (ADA) for 4 weeks and infliximab for 4–8 weeks before RTX therapy. However, it is not clear whether this is necessary to prevent infections or whether discontinuation leads to disease exacerbation. We describe a retrospective analysis of 18 consecutively selected patients with long-standing active RA according to the ACR 1987 classification criteria who received RTX therapy. The pro and contra for combination therapy was discussed with the patient and an informed patient consent was obtained for this study. Patients were previously treated with up to six DMARDs and three anti-TNF-drugs, but still had significant disease activity. Patients were mostly treated with MTX, LEF or MTX þ LEF in combination with ETN or ADA. Anti-TNF-drugs were discontinued and 2 weeks later RTX therapy was initiated with two infusions of 1 g within 2 weeks. Pre-medication with 100 mg pred-nisone was used to prevent anaphylactoid reactions. Concomitant DMARDs were not changed. During the follow-up period intra-articular steroid injections and oral pulses with up to 40 mg prednisone were offered to patients with active synovitis. Follow-up visits were scheduled 4 and 8 months after the first RTX infusion or earlier if necessary. Two months after the first RTX infusion six patients did not achieve a satisfying clinical response and had persistently high CRP and ESR parameters. Results from the REFLEX study showed that the clinical benefit of RTX appears $4 weeks after the first infusion with a DAS-28 improvement of À1.6 after 4 weeks and À1.8 after 12 weeks [3]. Therefore, these six patients restarted anti-TNF-therapy with ETN, which corresponds to an RTX þ ETN combination because of the long-lasting …