TY - JOUR
T1 - Disease Activity, Physical Function, and Radiographic Progression After Longterm Therapy with Adalimumab Plus Methotrexate: 5-Year Results of PREMIER
AU - van der Heijde, Desiree
AU - Breedveld, Ferdinand C.
AU - Kavanaugh, Arthur F
AU - Keystone, Edward C.
AU - Landewe, Robert
AU - Patra, Kaushik
AU - Pangan, Aileen L.
PY - 2010/11
Y1 - 2010/11
N2 - 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
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
KW - ADALIMUMAB
KW - RADIOGRAPHIC PROGRESSION
KW - PHYSICAL FUNCTION
KW - RHEUMATOID ARTHRITIS
KW - LONGTERM TREATMENT
U2 - 10.3899/jrheum.100208
DO - 10.3899/jrheum.100208
M3 - Article
C2 - 20889601
SN - 0315-162X
VL - 37
SP - 2237
EP - 2246
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 11
ER -