Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study
van de Putte, L. B. A.; Rau, R.; Breedveld, F. C.et al.
2003 • In Annals of the Rheumatic Diseases, 62 (12), p. 1168-1177
[en] OBJECTIVES: To evaluate efficacy, dose response, safety, and tolerability of
adalimumab (D2E7) in disease modifying antirheumatic drug (DMARD) refractory
patients with longstanding, active rheumatoid arthritis (RA). METHODS: During a
12 week, double blind, placebo controlled study, 284 patients were randomly
allocated to receive weekly subcutaneous injections of adalimumab 20 mg (n = 72),
40 mg (n = 70), or 80 mg (n = 72) or placebo (n = 70) without concomitant DMARDs.
RESULTS: Adalimumab significantly improved the signs and symptoms of RA for all
efficacy measures. ACR20 responses with adalimumab were significant at each
assessment versus placebo (p</=0.01). Additionally, ACR responses with adalimumab
were achieved more rapidly than with placebo, with 82/115 (71%) of the ultimate
ACR20 response rate to adalimumab treatment achieved at week 2. At week 12, for
adalimumab 20, 40, and 80 mg, ACR20 response rates were 50.7%, 57.1%, and 54.2%,
respectively, versus 10.0% for placebo (p</=0.001 for all comparisons); ACR50
rates were 23.9%, 27.1%, and 19.4%, respectively, versus 1.4% for placebo
(p</=0.001 for all comparisons); and ACR70 rates were 11.3%, 10.0%, and 8.3%,
respectively, versus 0.0% for placebo (p</=0.05 for all comparisons). All
adalimumab doses significantly improved all ACR core criteria at all assessments.
The 40 mg and 80 mg doses provided similar benefit. Adalimumab at all doses was
generally well tolerated, with only mild or moderate adverse events. Completion
rates were 87% for adalimumab and 67% for placebo. CONCLUSIONS: Adalimumab given
as monotreatment to patients with longstanding, severe RA refractory to
traditional DMARDs produced a rapid, sustained response and was safe and well
tolerated, with no dose limiting side effects.
Disciplines :
Rheumatology
Author, co-author :
van de Putte, L. B. A.
Rau, R.
Breedveld, F. C.
Kalden, J. R.
Malaise, Michel ; Université de Liège - ULiège > Département des sciences cliniques > Rhumatologie
Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study
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