Adalimumab, a human anti-TNF monoclonal antibody, outcome study for the prevention of joint damage in Japanese patients with early rheumatoid arthritis: the HOPEFUL 1 study.

Abstract

OBJECTIVES:

To evaluate the efficacy and safety of adalimumab+methotrexate (MTX) in Japanese patients with early rheumatoid arthritis (RA) who had not previously received MTX or biologics.

METHODS:

This randomised, double-blind, placebo-controlled, multicentre study evaluated adalimumab 40 mg every other week+MTX 6-8 mg every week versus MTX 6-8 mg every week alone for 26 weeks in patients with RA (≤2-year duration). The primary endpoint was inhibition of radiographic progression (change (Δ) from baseline in modified total Sharp score (mTSS)) at week 26.

RESULTS:

A total of 171 patients received adalimumab+MTX (mean dose, 6.2±0.8 mg/week) and 163 patients received MTX alone (mean dose, 6.6±0.6 mg/week, p<0.001). The mean RA duration was 0.3 years and 315 (94.3%) had high disease activity (DAS28>5.1). Adalimumab+MTX significantly inhibited radiographic progression at week 26 versus MTX alone (ΔmTSS, 1.5±6.1 vs 2.4±3.2, respectively; p<0.001). Significantly more patients in the adalimumab+MTX group (62.0%) did not show radiographic progression (ΔmTSS≤0.5) versus the MTX alone group (35.4%; p<0.001). Patients treated with adalimumab+MTX were significantly more likely to achieve American College of Rheumatology responses and achieve clinical remission, using various definitions, at 26 weeks versus MTX alone. Combination therapy was well tolerated, and no new safety signals were observed.

CONCLUSIONS:

Adalimumab in combination with low-dose MTX was well tolerated and efficacious in suppressing radiographic progression and improving clinical outcomes in Japanese patients with early RA and high disease activity.

• Authors: Tsutomu Takeuchi, Hisashi Yamanaka, Naoki Ishiguro, Nobuyuki Miyasaka, Masaya Mukai, Tsukasa Matsubara, Shoji Uchida, Hideto Akama, Hartmut Kupper, Vipin Arora, Yoshiya Tanaka
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 73 Issue 3 Pg. 536-43 (Mar 2014) ISSN: 1468-2060 [Electronic] England
• PMID: 23316080 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents
• Tumor Necrosis Factor-alpha
• Adalimumab
• Methotrexate

Topics

• Adalimumab
• Adult
• Aged
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects, therapeutic use)
• Antirheumatic Agents (administration & dosage, adverse effects, therapeutic use)
• Arthritis, Rheumatoid (diagnostic imaging, drug therapy)
• Disease Progression
• Double-Blind Method
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• Humans
• Male
• Methotrexate (administration & dosage, adverse effects, therapeutic use)
• Middle Aged
• Radiography
• Remission Induction
• Secondary Prevention (methods)
• Severity of Illness Index
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)
• Young Adult