Abstract
Objective. To assess longterm safety in a US cohort of patients with rheumatoid arthritis (RA) treated with adalimumab (ADA) in real-world clinical care settings.
Methods. This observational study analyzed the longterm incidence of safety outcomes among patients with RA initiating ADA, using data from the Corrona RA registry. Patients were adults (≥ 18 yrs) who initiated ADA treatment between January 2008 and June 2017, and who had at least 1 followup visit.
Results. In total, 2798 ADA initiators were available for analysis, with a mean age of 54.5 years, 77% female, and mean disease duration of 8.3 years. Nearly half (48%) were biologic-naive, and 9% were using prednisone ≥ 10 mg at ADA 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% CI 2.45–4.84) than in subsequent years, while other measured adverse effects did not vary substantially by duration of exposure. The median time to ADA 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 longterm 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 ADA treatment and provides guidance for physicians prescribing ADA for extended periods.
Footnotes
Full Release Article. For details see Reprints and Permissions at jrheum.org.
Financial support for the study was provided by AbbVie, which manufactures adalimumab. AbbVie participated in the interpretation of data, and review and approval of the manuscript. The study was 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 Co., Genentech, Gilead, GSK, Horizon Pharma USA, Janssen, Momenta Pharmaceuticals, Novartis, Pfizer Inc., Roche, Merck, UCB, and Valeant. The study design and conduct were a collaboration between Corrona and AbbVie. L.R. Harrold is an employee and shareholder of Corrona LLC. C.J. Barr is an employee and shareholder of Corrona LLC. H.J. Litman is an employee of Corrona LLC. J. Griffith, S.S. Islam, D. Guo, J. Fay, and P. Zueger are employees of AbbVie Inc. and own AbbVie stock. J.D. Greenberg is an employee and shareholder of Corrona LLC. L.R. Harrold, MD, MPH, University of Massachusetts Medical School, and Corrona LLC; J. Griffith, PharmD, AbbVie; P. Zueger, PharmD, PhD, AbbVie; H.J. Litman, PhD, Corrona LLC; B. Gershenson, MPH, University of Massachusetts Medical School; S.S. Islam, MD, MSPH, DrPH, AbbVie; C.J. Barr, MPH, Corrona LLC; D. Guo, MD, PhD, AbbVie; J. Fay, MD, AbbVie; J.D. Greenberg, MD, MPH, Corrona LLC, and New York University School of Medicine.
- Accepted for publication July 29, 2019.
Free online via JRheum Full Release option