Background Results have been previously presented from a long-term safety trial of ENBREL as monotherapy in adult patients with RA who had failed at least one DMARD. In this ongoing study, 628 patients have been followed for up to 4.3 years (median = 2.4 years) for a total of 1336 patient-years.
Objectives Continue to observe the long-term safety and clinical benefit of ENBREL.
Methods Patients were evaluated for disease activity using ACR criteria. Adverse event rates were compared with data from controlled studies.
Results 479 adult patients have received ENBREL as monotherapy for over 1 year, 420 for over 2 years, 164 for over 3 years, and 12 for over 4 years. Response has been sustained for the duration of therapy. At baseline, the median tender joint count was 31 and the median swollen joint count was 25. At 3.5 years, the median tender and swollen joint counts were 3 each, and 69% of patients had achieved the ACR 20, 50% the ACR 50, and 25% the ACR 70. Also at 3.5 years, 24% of patients had zero tender joints, 26% had zero swollen joints, and 15% had disability scores of zero. In addition, 59% of patients who were receiving corticosteroids at study start have decreased their steroid doses by a mean of 71%, 29% of patients have completely discontinued steroids, and only 5% have increased their steroid dose. Compared to events seen in controlled trials or in the normal adult population, no significant differences in rate or type of adverse events were seen in patients treated with ENBREL over time. Serious adverse events occurred at a rate of 0.13 per patient-year in the long-term database compared to 0.13 in ENBREL-treated patients and 0.20 in placebo patients in the controlled studies. Likewise, serious infections (associated with hospitalisation or IV antibiotics) occurred at a rate of 0.05 per patient-year in the long-term database compared to 0.04 in ENBREL patients and 0.05 in placebo patients in the controlled studies. The number of malignancies reported in ENBREL patients was similar to the expected number calculated from the National Cancer Institute SEER database (9 reported vs. 12.7 expected). No opportunistic infections have been observed.
Conclusion ENBREL as monotherapy continues to be safe and effective in patients with DMARD-refractory RA for over 4 years.
Moreland LW, et al. Arthritis Rheum. 2000;43:S270
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