Department of Medicine, Division of Rheumatology
Amino Acids, Peptides, and Proteins | Immune System Diseases | Investigative Techniques | Musculoskeletal Diseases | Pharmaceutical Preparations | Public Health | Skin and Connective Tissue Diseases | Therapeutics
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 naive, 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.
adverse effects, rheumatoid arthritis, registries
Rights and Permissions
© 2019 The Journal of Rheumatology. Authors' accepted peer-reviewed manuscript posted after 12 months as allowed by the publisher's author rights policy at http://www.jrheum.org/guideforauthors#selfarchiving.
DOI of Published Version
J Rheumatol. 2019 Aug 1. pii: jrheum.190260. doi: 10.3899/jrheum.190260. [Epub ahead of print] Link to article on publisher's site
The Journal of rheumatology
Harrold LR, Griffith J, Zueger P, Litman HJ, Gershenson B, Islam SS, Barr CJ, Guo D, Fay J, Greenberg JD. (2019). Long-term, Real-world Safety of Adalimumab in Rheumatoid Arthritis: Analysis of a Prospective US-Based Registry. Open Access Articles. https://doi.org/10.3899/jrheum.190260. Retrieved from https://escholarship.umassmed.edu/oapubs/3956
Available for download on Saturday, August 01, 2020
Amino Acids, Peptides, and Proteins Commons, Immune System Diseases Commons, Investigative Techniques Commons, Musculoskeletal Diseases Commons, Pharmaceutical Preparations Commons, Public Health Commons, Skin and Connective Tissue Diseases Commons, Therapeutics Commons