Is Adalimumab Safe for Long-Term Use?
For their meta-analysis, the researchers examined the safety of adalimumab using data from 78 clinical trials that included 29,987 patients with either rheumatoid arthritis (RA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), peripheral SpA (pSpA), PsA, plaque psoriasis (Ps), HS, Crohn disease (CD), ulcerative colitis (UC), or non-infectious uveitis (UV), representing 56,951 patient-years of exposure.
All serious adverse events that occurred from the initiation of adalimumab to 70 days post-initiation were assessed. Serious adverse events were defined as infections, demyelinating disorder, lupus-like syndrome, congestive heart failure, new onset or worsening psoriasis, malignancy, and sarcoidosis. The researchers evaluated the rates for serious adverse events, the time to first malignancy, and mortality.
Infections were the most frequently reported serious adverse event, the most common of which included pneumonia and cellulitis.
Overall, the rate of serious malignancies, excluding lymphoma and skin cancers, was 0.6 per 100 patient-years, which ranged from 0.1 to 0.7 per 100 patient-years across all indications. The highest reported rates for malignancies were among patients with RA, UV, and UC. In addition, the overall rate of non-melanoma skin cancer was 0.1 per 100 patient-years, which ranged from 0 to 0.2 per 100 patient-years across all indications. However, the time to first malignancy did not differ significantly across indications, excluding lymphoma and non-melanoma skin cancer.
Additionally, the researchers observed that the number of deaths in patients with AS, PsA, Ps, UC, CD, and RA were below what would be expected in age- and sex-adjusted populations. However, the small population size of trials that included patients with HS, nr-axSpA, pSpA, and UV prevented the researchers from accurately calculating mortality ratios.
“This analysis of data from clinical trials of adalimumab demonstrated an overall safety profile consistent with previous findings and with the [anti-tumor necrosis factor-α] class,” the researchers concluded. “No new safety signals or tolerability issues with adalimumab were identified. Efficacy and safety data continue to support the well-established benefits of adalimumab for the approved indications.”
Burmester GR, Panaccione R, Gordon KB, et al. Long-term safety of adalimumab in adult patients from global clinical trials across multiple indications: an updated analysis in 29,2987 patients representing 56,951 patient-years. Presented at: The Winter Clinical Dermatology Conference; January 12-17, 2018; Maui, Hawaii.