Adalimumab exposure in six immune-medicated inflammatory diseases showed individual differences by disease population and safety consistent with anti-tumor necrosis factor drugs with no new long-term safety signals, according to study results.
Researchers analyzed 71 global, clinical trials of 23,458 patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis, psoriatic arthritis, psoriasis (Ps) and Crohn’s disease (CD) who were assigned adalimumab. Safety was assessed per 100 patient-years by using all adverse events occurring after the first dose of adalimumab through 70 days after the last study dose. The analysis spanned nearly 12 years. Standardized incidence rates for malignancies and death rates were calculated through National Cancer Institute and WHO data, respectively.
Infections were the most reported serious adverse reaction, with the greatest incidences in RA and CD trials. Malignancy rates for patients assigned adalimumab were relative with the age- and sex-matched general population. Lymphoma incidents in patients with RA were significantly greater than expected when compared with a comparable U.S. population, with a standardized incidence rate (SIR) of 2.74 (95% CI, 1.38-3.93). A higher SIR of nonmelanoma skin cancer was observed in patients with RA (1.39; 95% CI, 1.19-1.60), Ps (1.76; 95% CI, 1.26-2.39) and CD (2.29; 95% CI, 1.44-3.47) compared with the general public. Death rates were reported in all diseases except JIA and were lower than or equivalent to age- and sex-matched general population expectations.
“Whether control of inflammation with adalimumab decreases certain mortality risks, such as cardiovascular disease and use of steroids, is yet to be determined,” the researchers said, adding that data “provide important additional support for the long-term safety of adalimumab … highlighting important differences among patient populations, and demonstrating stability of incident rates over time with no new safety signals.”
Disclosure: See the study for a full list of relevant disclosures.