Background Results have been previously presented from a long-term trial of ENBREL as additional therapy in 79 patients with persistent RA despite treatment with MTX. Patients have now received therapy for a median of 32 months (max. 37).
Objectives Continue to observe the safety and clinical benefit of ENBREL plus MTX.
Methods Disease activity was evaluated using ACR criteria. Adverse events were compared with data from a previous controlled study.
Results Of the 79 patients who entered the long-term trial, 9 have withdrawn: 3 for lack of efficacy, 2 for adverse events, 1 prior to a total knee replacement, 2 who planned to conceive, and 1 who started taking commercial ENBREL. Seventy of the 79 patients who entered the long-term study remain on therapy. No differences have been seen in the type and rate of adverse events observed over time, compared to the earlier controlled study. In the initial 6-month blinded study of ENBREL plus MTX, 2/59 patients were hospitalised for infections; in the extension study, 2/79 patients had a similar event. One patient developed NHL of the parotid gland in the initial study. In the extension study, two patients developed malignancies (squamous cell carcinoma of the larynx and breast carcinoma). Both of these patients in the extension study recovered and have resumed treatment with ENBREL. At baseline, all 79 patients were taking MTX and the mean dose was 18 mg. As allowed by the protocol, 54 (68%) patients have reduced their MTX dose by a mean of 63%, and 22/79 (28%) patients have discontinued taking MTX. In the 45 patients taking corticosteroids, the mean dose of prednisone was 6.3 mg. As allowed by the protocol, 30 (67%) patients have reduced their steroid dose by a mean of 78%, and 19 (42%) patients have discontinued steroids. Improvement of disease activity has been sustained even though MTX and steroids were reduced or discontinued. At the most recent visit, 69% of patients had achieved the ACR 20, 51% the ACR 50, and 27% the ACR 70. Also at the most recent visit, 19 patients had no tender joints, 10 had no swollen joints, and a zero HAQ score was achieved by 12 patients.
Conclusion ENBREL plus MTX remains safe and well tolerated. Improvement of disease activity is sustained even with reduced or discontinued doses of MTX and/or steroids.
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Weinblatt ME, et al. NEJM 1999;340:253–9
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