5-year remission rate after the discontinuation of adalimumab in patients with rheumatoid arthritis: Long-term follow-up results of the HONOR study

Abstract

Objectives: To determine the rate and factors associated with remission (disease activity score (DAS) 28-erythrocyte sedimentation rate (ESR) of <2.6) during a 5-year follow-up after the discontinuation of adalimumab (ADA) in patients with rheumatoid arthritis (RA).

Methods: 75 patients who had been treated with ADA + methotrexate (MTX) and maintained DAS28-ESR <2.6 for at least 6 months were enrolled. Among them, 52 patients discontinued ADA, and 46 patients completed a 5-year follow-up.

Results: During the 5 years, 11 patients had DAS28-ESR <2.6. In 15 patients with DAS28-ESR <3.2, no significant changes were found in the health assessment questionnaire disability index (HAQ-DI) and modified total Sharp score (mTSS). When comparing patients with DAS28-ESR ≤1.61 versus 1.61 <DAS28-ESR <2.6, 50% and 15% of the two groups demonstrated sustained remission, respectively. Remission was more common in patients with shorter disease duration (≤2 years) than those with longer duration (>2 years). Among 31 patients who experienced flare, ADA was restarted in 24 patients, and 17 patients of these achieved DAS28-ESR <3.2 within 1-year.

Conclusion: During the 5-year ADA-free period, remission rate was persistent in 21% of the patients. ADA-free remission was possible especially in patients with deeper remission (DAS28-ESR ≤1.61) and shorter disease duration (≤2 years).

Keywords:

• Discontinuation
• HONOR study
• remission
• rheumatoid arthritis
• TNF inhibitor

Ethical approval

Ethics review board of the University of Occupational and Environmental Health, Japan.

Acknowledgements

The authors thank all the medical staff at all participating institutions for providing the data.

Author contributions

SH, KS and YT contributed to the conception and design of the study. All authors enrolled and managed the patients in clinic. SH, SK, SF and KH participated in radiographic evaluation. SH and AY performed the statistical analysis. All authors read and approved the final manuscript.

Conflict of interest

YT has received speaking fees and/or honoraria from Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, Abbvie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Teijin and has received research grants from Asahi-kasei, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Ono. SH has received consultancy fee, advisory fee, or speakers bureau from Abbvie, Asahi-Kasei Pharma, Asahi-Kasei Medical, Astellas, Ayumi, Bristol-Myers Squibb, Celgene, Chugai, Eisai, Eli Lilly, Janssen, Kissei, Novartis, Pfizer, Sanofi, Takeda, Tanabe-Mitsubishi, and UCB. KS has received speaking fees from Eli Lilly. SN has received speaking fees from Bristol-Myers, Sanofi, Abbvie, Eisai, Chugai, Pfizer, Takeda, Asahi-kasei and also research grants from Mitsubishi-Tanabe, Novartis and MSD. KN has received speaking fees from Astellas, UCB, Mitsubishi-Tanabe, Eisai and has received research grants from Mitsubishi-Tanabe, Eisai, and Eli Lilly. SK has received speaking fees from Bristol-Myers, Pfizer, Takeda, and Eli Lilly. The other authors declare no conflict of interest.