Real-World Data Show Safety Profile of Adalimumab Similar to Previous Findings

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Real-world data demonstrated adalimumab to have a safety profile consistent with previous studies and did not identify any new safety signals with long-term treatment.

An analysis of a prospective real-world registry found adalimumab, a TNF inhibitor, to have a safety profile consistent with that observed in previous research in patients with rheumatoid arthritis (RA). The analysis also found no new safety signals associated with long-term adalimumab administration in patients with RA. Findings from this analysis were published in the Journal of Rheumatology.

A prospective, observational cohort of patients with RA, the US Corrona RA Registry, was retrospectively reviewed. Researchers obtained data from patients with RA (mean age, 54.5 years; mean disease duration, 8.3 years) who initiated treatment with adalimumab between January 2008 and June 2017 and had ≥1 follow-up visit (n=2798). Several safety outcomes of interest were analyzed, including physician-reported serious infections, malignancies (excluding nonmelanoma skin cancer), congestive heart failure that required hospitalization, tuberculosis, and drug-induced systemic lupus erythematosus. The researchers also assessed all-cause mortality.

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Approximately 48% of the cohort was biologic naïve, whereas 9% were using ≥10 mg prednisone daily at the time of adalimumab initiation. More than half of patients (60%) were receiving concomitant methotrexate at the start of adalimumab treatment.

The majority of patients (84%) were treated with adalimumab for <3 years. The incidence rates for the assessed safety outcomes were 1.86 person-years for serious infections, 0.15 person-years for congestive heart failure requiring hospitalization, 0.64 person-years for malignancy, and 0.33 person-years for all-cause mortality.

In the first year of therapy, the researchers found a higher incidence of serious infections compared with subsequent years (3.44 person-years; 95% CI, 2.45-4.84). The median time to discontinuation of therapy was 11 months. In patients who experienced a serious infection event, the median time to first serious infection was 12 months. At 12 months, the percentage of patients not having a first occurrence of serious infection and malignancy were 97.5% and 99.4%, respectively.

Limitations of the analysis were the inclusion of patients who had adalimumab exposure of only ≤1 year and the lack of information regarding whether adalimumab exposure had an impact on the development of the measured adverse events.

“This confirmation of existing knowledge may reassure providers who are initiating and monitoring [adalimumab] in their patients,” the researchers wrote.

Disclosure: This study was sponsored by Corrona, LLC, with financial support from AbbVie. Please see the original reference for a full list of authors’ disclosures.


Harrold LR, Griffith J, Zueger P, et al. Long-term, real-world safety of adalimumab in rheumatoid arthritis: analysis of a prospective US-based registry [published online August 1, 2019]. J Rheumatol. doi:10.3899/jrheum.190260