RT Journal Article
SR Electronic
T1 Disease Activity, Physical Function, and Radiographic Progression After Longterm Therapy with Adalimumab Plus Methotrexate: 5-Year Results of PREMIER
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2237
OP 2246
DO 10.3899/jrheum.100208
VO 37
IS 11
A1 DÉSIRÉE van der HEIJDE
A1 FERDINAND C. BREEDVELD
A1 ARTHUR KAVANAUGH
A1 EDWARD C. KEYSTONE
A1 ROBERT LANDEWÉ
A1 KAUSHIK PATRA
A1 AILEEN L. PANGAN
YR 2010
UL http://www.jrheum.org/content/37/11/2237.abstract
AB Objective. To evaluate the efficacy and safety of initial combination treatment with adalimumab (ADA) and methotrexate (MTX) versus monotherapy with ADA or MTX during an open-label extension of PREMIER. Methods. Patients with early rheumatoid arthritis (RA) received blinded ADA plus MTX, ADA alone, or MTX alone for 2 years in PREMIER. At Year 2, patients could enroll in an open-label extension and receive ADA monotherapy; MTX could be added at the investigator’s discretion. Longterm efficacy results are presented as observed data. Results. In the open-label period, 497 of the original 799 randomized patients had ≥ 1 dose of ADA (by original randomization: ADA plus MTX, n = 183; ADA, n = 159; MTX, n = 155). In the completers cohort [patients with available Year-5 ACR responses and modified total Sharp scores (mTSS)], the Year-5 mean change from baseline in mTSS for the ADA+MTX arm (n = 124) was 2.9, compared with 8.7 and 9.7 in the ADA (n = 115) and MTX (n = 115) arms. Comprehensive disease remission, defined as the combination of DAS28 remission, normal function (Health Assessment Questionnaire ≤ 0.5), and radiographic nonprogression (ΔmTSS ≤ 0.5), was achieved by more patients in the initial ADA+MTX arm (35%) than in the ADA (13%) or MTX (14%) arms. Conclusion. Initial combination treatment with ADA plus MTX, followed by open-label ADA, led to better longterm clinical, functional, and radiographic outcomes than either initial ADA or MTX monotherapy during 5 years of treatment.