RT Journal Article
T1 Efficacy and safety of the human anti-IL-1beta monoclonal antibody canakinumab in rheumatoid arthritis: results of a 12-week, phase II, dose-finding study
A1 Alten, Rieke
A1 Gómez-Reino Carnota, Juan Jesús
A1 Durez, Patrick
A1 Sebba, Anthony
A1 Krammer, Gerhard
A1 Preiss, Ralph
A1 Arulmani, Udayasankar
A1 Widmer, Albert
A1 Gitton, Xavier
A1 Kellner, Herbert
K1 Rheumatoid Arthritis
K1 Anakinra
K1 Active Rheumatoid Arthritis
K1 Triamcinolone Acetonide
K1 Gouty Arthritis
AB BackgroundCanakinumab is a fully human anti-interleukin IL-1beta monoclonal antibody, being investigated for the treatment of rheumatoid arthritis (RA). This multicenter, phase II, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study investigated the efficacy and safety of canakinumab in patients with active RA despite ongoing therapy at stable doses of methotrexate.MethodsPatients were randomized to receive one of four regimens, in addition to methotrexate, for 12 weeks: canakinumab 150 mg subcutaneously (SC) every 4 weeks (q4wk), canakinumab 300 mg SC (2 injections of 150 mg SC) every 2 weeks, a 600 mg intravenous loading dose of canakinumab followed by 300 mg SC every 2 weeks', or placebo SC every 2 weeks.ResultsAmong 274 patients with evaluable efficacy data, the percentage of responders according to American College of Rheumatology 50 criteria (the primary endpoint, based on a 28-joint count) was significantly higher with canakinumab 150 mg SC q4wk than with placebo (26.5% vs. 11.4%, respectively; p = 0.028). Compared to placebo, this dosage of canakinumab was also associated with significantly more favorable responses at week 12 with respect to secondary endpoints including the Disease Activity Score 28, scores on the Health Assessment Questionnaire and Functional Assessment of Chronic Illness Therapy-Fatigue, swollen 28-joint count, and patient's and physician's global assessments of disease activity. No safety concerns were raised with canakinumab therapy, particularly with regard to infections. Few injection-site reactions occurred.ConclusionThe addition of canakinumab 150 mg SC q4wk improves therapeutic responses among patients who have active RA despite stable treatment with methotrexate.Trial Registration(ClinicalTrials.gov identifier: NCT00784628)
PB BMC
SN 1471-2474
YR 2011
FD 2011
LK http://hdl.handle.net/10347/23040
UL http://hdl.handle.net/10347/23040
LA eng
NO Alten, R., Gomez-Reino, J., Durez, P. et al. Efficacy and safety of the human anti-IL-1beta monoclonal antibody canakinumab in rheumatoid arthritis: results of a 12-week, phase II, dose-finding study. BMC Musculoskelet Disord 12, 153 (2011). https://doi.org/10.1186/1471-2474-12-153
NO This study was supported by Novartis Pharma AG, Basel, Switzerland. Medicalwriting assistance provided by BioScience Communications, Inc., wassupported by Novartis Pharma AG, Basel, Switzerland
DS Minerva
RD 29 abr 2026