Real-World Safety and Effectiveness of Adalimumab in Patients with Non-Infectious Intermediate, Posterior, or Panuveitis: A Post-Marketing Surveillance Study in Korea.

PURPOSE: This post-marketing surveillance study reports the real-world safety and effectiveness of adalimumab (Humira®, AbbVie Inc.) among patients with non-infectious intermediate, posterior, or panuveitis (NIIPPU) in Korea. METHODS: The study was conducted at 17 medical centres from January 2018 to July 2020. Safety (155 patients) was analysed by collecting adverse events (AEs) and adverse drug reactions (ADRs) data. Effectiveness assessments (148 patients) included anterior chamber cell grade, vitreous haze grade, and best corrected visual acuity (BCVA) change. RESULTS: At baseline, the mean duration of uveitis was 3.9 ± 4.0 years (n = 101) and the mean number of relapses in the past year was 2.5 (n = 52). The most common anatomical uveitis phenotype was panuveitis (n = 110, 71.0%). One patient received prior infliximab; within the previous 3 months, 75.4% and 93.3% of patients received glucocorticoids and immunosuppressants, respectively. The mean daily corticosteroid dose decreased from 9.7 ± 7.8 mg at the start of the study to 6.6 ± 6.0 mg at the end of the study (p < 0.0001). AEs and ADRs were reported in 13 patients (8.4%, 1.9% serious) and 5 patients (3.2%), respectively. The most common ADR was injection-site discomfort. Twenty-nine patients (18.7%) discontinued adalimumab within 6 months; 34 patients discontinued during follow-up, most commonly for cost issues (64.7%). Three patients discontinued adalimumab due to AEs. Regarding effectiveness, from baseline to 22 weeks, anterior chamber inflammation and vitreous haze tended to improve significantly; there was no BCVA worsening. CONCLUSION: In the real-world setting, adalimumab treatment showed an acceptable safety profile, with serious AEs reported in three patients but no serious ADRs related to adalimumab, and demonstrated potential effectiveness in Korean patients with NIIPPU.