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Long-term, Real-world Safety of Adalimumab in Rheumatoid Arthritis: Analysis of a Prospective US-Based Registry

Author

Harrold LR1, Griffith J1, Zueger P1, Litman HJ1, Gershenson B1, Islam SS1, Barr CJ1, Guo D1, Fay J1, Greenberg JD1. J Rheumatol. 2019 Aug 1. pii: jrheum.190260. doi: 10.3899/jrheum.190260. [Epub ahead of print]

Author Information

1 From the University of Massachusetts Medical School, Worcester, MA, USA; Corrona, LLC, Waltham, MA, USA; AbbVie, North Chicago, IL, USA; New York University School of Medicine, New York, NY, USA. This study is sponsored by Corrona, LLC. Corrona, LLC has been supported through contracted subscriptions in the last 2 years by AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Crescendo, Eli Lilly and Company, Genentech, Gilead, GSK, Horizon Pharma USA, Janssen, Momenta Pharmaceuticals, Novartis, Pfizer Inc, Roche, Merck, UCB and Valeant. Financial support for the study was provided by AbbVie. The study design and conduct were a collaboration between Corrona and AbbVie. AbbVie participated in the interpretation of data, review and approval of the manuscript. LR Harrold is an employee and shareholder of Corrona, LLC. She has been a consultant to AbbVie, BMS, and Roche and has a research grant from Pfizer. CJ Barr is an employee and shareholder of Corrona, LLC. HJ Litman is an employee of Corrona, LLC. B Gershenson is an employee of University of Massachusetts Medical School. J Griffith, SS Islam, D Guo, J Fay, and P Zueger are employees of AbbVie Inc. and own AbbVie stock. J Greenberg is an employee and shareholder of Corrona, LLC. He has been a consultant to Genentech, Janssen, Novartis, Pfizer and Eli Lilly.

Abstract

OBJECTIVE: 

To assess long-term safety in a US cohort of rheumatoid arthritis (RA) patients treated with adalimumab in real-world clinical care settings.

METHODS: 

This observational study analyzed the long-term incidence of safety outcomes among RA patients initiating adalimumab using data from the Corrona RA registry. Patients were adults (≥18 years) who initiated adalimumab treatment between January 2008 and June 2017, and who had at least 1 follow-up visit.

RESULTS: 

In total, 2798 adalimumab initiators were available for analysis, with a mean age of 54.5 years, 77% female, and mean duration of disease of 8.3 years. Nearly half (48%) were biologic naïve, and 9% were using prednisone ≥10 mg at adalimumab initiation. The incidence rates per 100 person-years for serious infections, congestive heart failure requiring hospitalization, malignancy (excluding nonmelanoma skin cancer), and all-cause mortality were 1.86, 0.15, 0.64, and 0.33, respectively. The incidence of serious infections was higher in the first year of therapy (3.44 [95% confidence interval: 2.45-4.84]) than subsequent years, while other measured AEs did not vary substantially by duration of exposure. The median time to adalimumab discontinuation was 11 months, while the median time to first serious infection among those experiencing a serious infection event was 12 months.

CONCLUSION: 

Analysis of long-term data from this prospective real-world registry demonstrated a safety profile consistent with previous studies in patients with RA. This analysis did not identify any new safety signals associated with adalimumab treatment and provides valuable guidance for physicians prescribing adalimumab for extended periods of time.