Upadacitinib Safety Outcomes Over 15000 Patient-Years

Researchers, led by Gerd R Burmester, conducted a clinical trial to evaluate the long-term safety outcomes of upadacitinib in the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and atopic dermatitis (AD).

Based on safety data from clinical trials published by June 30 2021, the team reported upadacitinib was generally well tolerated and noted that differences in safety outcomes between groups likely derived from varying characteristics of RA, PsA, AS, and AD populations. Findings were presented in RMD Open.

Upadacitinib Safety Differs Slightly Across Rheumatic Diseases

The authors’ analysis included 6991 patients in total, of which 3209 had RA, 907 had PsA, 182 had AS, and 2693 had AD. Upadacitinib doses were 15 mg in RA, PsA, and AS, and 30 mg in AD only, and some RA and PsA studies evaluated adalimumab and methotrexate as active comparators. Treatment-emergent adverse events (TEAEs) by disease group were expressed as exposure-adjusted events per 100 patient-years.

The pooled cohort encompassed 15425 patient-years of upadacitinib exposure (maximum treatment duration range, 2.75-5.45 years). According to the study’s authors, rates of any TEAE and TEAEs leading to discontinuation were similar across disease groups, ranging from 205.5-278.1 and 4.5-5.4 events per 100-patient years, respectively.

Investigators noted the rate of serious TEAEs was numerically higher in the RA and PsA groups. Rates of herpes zoster (1.6-3.6), non-melanoma skin cancer (0-0.8), and elevations in creatine phosphokinase levels (4.4-7.9) were higher with upadacitinib compared with active comparators in RA and PsA patients.

Authors found event rates per 100 patient-years for deaths (0-0.8), serious infections (0-3.9), major adverse cardiovascular events (0-0.4), venous thromboembolisms (<0.1-0.4), and malignancies (0.3-1.4) were typically lowest in patients with AS and AD, and rates of acne were increased in patients with AD.

Ultimately, Burmester and colleagues summarized that their “analyses of long-term data demonstrate that upadacitinib was generally well tolerated in RA, PsA, AS and AD with no new safety risks identified compared with previous reports.”

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