Disease Activity, Physical Function, and Radiographic Progression After Longterm Therapy with Adalimumab Plus Methotrexate: 5-Year Results of PREMIER

Desiree van der Heijde, Ferdinand C. Breedveld, Arthur F Kavanaugh, Edward C. Keystone, Robert Landewe, Kaushik Patra, Aileen L. Pangan*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

64 Citations (Web of Science)

Abstract

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
Original languageEnglish
Pages (from-to)2237-2246
JournalJournal of Rheumatology
Volume37
Issue number11
DOIs
Publication statusPublished - Nov 2010

Keywords

  • ADALIMUMAB
  • RADIOGRAPHIC PROGRESSION
  • PHYSICAL FUNCTION
  • RHEUMATOID ARTHRITIS
  • LONGTERM TREATMENT

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