Long-term safety profile of adalimumab across indications confirmed

A recent data analysis of 78 clinical trials of adalimumab demonstrated an overall safety profile consistent with previous findings and the tumor necrosis factor (TNF) inhibitor class.

For most indications, the mortality rate was below expectation in an age-adjusted and sex-adjusted population.

A recent analysis of data from 78 clinical trials of adalimumab demonstrated an overall safety profile that was consistent with previous findings and with the tumor necrosis factor (TNF) inhibitor class in general. No new safety signals or tolerability issues with adalimumab treatment were identified.

According to Professor Gerd Burmester (Charité University Hospital, Free University and Humboldt University of Berlin, Germany), aspects on the efficacy of adalimumab are well known, but patients now want to be informed about the safety of the treatment; especially as it often involves long-term use.
Its long-term safety was previously reported in 23,458 patients representing up to 12 years of clinical trial exposure in rheumatoid arthritis (RA), juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis (PsA), plaque psoriasis (Ps), and Crohn’s disease (CD) (1). This showed infections to be the most frequently reported serious adverse events (SAEs) across these indications. During EULAR 2018, Burmester et al. reported on an updated analysis examining the long-term safety of adalimumab in adult patients with RA, AS, non-radiographic axial spondyloarthritis (nr-axSpA), peripheral spondyloarthritis (pSpA), PsA, Ps, hidradenitis suppurativa (HS), CD, ulcerative colitis (UC), and non-infectious uveitis (UV). This analysis was based on 78 studies including 29,987 patients, representing 56,951 patient-years (PY) of exposure. Safety assessments included all AEs and SAEs that occurred after the first adalimumab dose and up to 70 days after the last study dose. The majority of patients who were exposed to adalimumab were those in RA studies (n=15,512). 

“The most frequently reported SAE of interest was infection with the highest incidences in CD, RA, UV, and UC,” Burmester said. “The most commonly reported serious infections were pneumonia (0.6/100 PY) and cellulitis (0.2/100 PY). The risk of a serious infection event was generally stable across time for all indications.” When malignancies were assessed, the overall rate of serious malignancies was 0.6/100 PY, excluding lymphoma, hepatosplenic T-cell lymphoma, leukemia, non-melanoma skin cancer (NMSC), and melanoma. The highest rates of malignancies were seen among RA, UV, and UC studies. For NMSC, the overall rate was 0.1/100 PY. The time to first malignancy, with the exclusion of the aforementioned exceptions, did not show any marked difference between indications. 

When the standardized mortality rates (SMR) were assessed, it emerged that overall and for most of the adalimumab populations (AS, PsA, Ps, UC, CD, and RA), the observed number of deaths was below expectation in an age-adjusted and sex-adjusted population. For HS, nr-axSpA, pSpA, and UV studies, the small size of these trials precluded accurate assessment of the SMR, and the 95% CIs all included 1.0. Burmester ended his presentation by concluding that the efficacy and safety data continue to support the well-established benefits of adalimumab for the approved indications (2).

1. Burmester G, et al. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease. Ann Rheum Dis 2013;72(4):517-524.
2. Burmester G, et al. Long-term safety of adalimumab in adult patients from global clinical trials across multiple indications: an updated analysis in 29,987 patients representing 56,951 patient-years. Abstract OP0233. EULAR 2018.

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