Long-Term Safety and Effectiveness of Adalimumab in Japanese Patients with Noninfectious Intermediate, Posterior, or Panuveitis: Post-Marketing Surveillance of 251 Patients

Kenichi Namba, Toshikatsu Kaburaki, Hidekazu Tsuruga, Yohei Ogawa, Eri Iwashita, Hiroshi Goto, Kenichi Namba, Toshikatsu Kaburaki, Hidekazu Tsuruga, Yohei Ogawa, Eri Iwashita, Hiroshi Goto

Abstract

Introduction: The aim of this nationwide, prospective post-marketing surveillance was to assess the safety and effectiveness of up to 52 weeks of adalimumab treatment in patients with noninfectious intermediate, posterior, or panuveitis in Japanese clinical practice.

Methods: This post-marketing surveillance was conducted at 60 medical facilities in Japan from October 2016 to June 2020. Patients with noninfectious intermediate, posterior, or panuveitis who were administered adalimumab (Humira®, AbbVie Inc.) for the first time were eligible. Subcutaneous adalimumab was initially administered at 80 mg, followed by 40 mg 1 week later, then 40 mg every 2 weeks. Safety measures included the incidence of adverse events (AEs) and adverse drug reactions (ADRs; primary endpoint). Effectiveness measures included visual acuity, anterior chamber cell grade, vitreous haze, macular edema, foveal retinal thickness, uveitis recurrence rate, and oral corticosteroid dose. Health-related quality of life was evaluated using the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25).

Results: During 52 weeks of surveillance, AEs and ADRs occurred in 70 (27.9%) and 47 (18.7%) of 251 patients, respectively. The most common ADR was infection (21/251 patients; 8.4%), including serious infections in eight (3.2%) patients. ADRs were more frequent in patients ≥ 65 years of age, those with concurrent diseases, and those with past medical history. Four patients developed tuberculosis. The uveitis recurrence rate was 24.8% (61/246 patients). All effectiveness measures tended to improve from baseline to week 52, and mean corticosteroid doses decreased. Clinically meaningful changes were observed for most VFQ-25 subscales.

Conclusions: The safety profile of adalimumab was generally consistent with previous reports, and no new safety concerns were identified.

Trial registration: ClinicalTrials.gov: NCT02916017.

Keywords: Adalimumab; Behçet’s Disease; Sarcoidosis; Uveitis; Vogt-Koyanagi-Harada Disease.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Patient disposition
Fig. 2
Fig. 2
Changes in the anterior chamber cell grade in a left eyes and b right eyes; changes in vitreous haze grade in c left eyes and d right eyes
Fig. 3
Fig. 3
Mean changes in the daily oral corticosteroid dose (prednisolone equivalent) from week 0 to week 52. Week 0 was the start of adalimumab administration. The number of patients at each time point, expressed as the number receiving concomitant corticosteroids over the total number of patients receiving adalimumab (n/N), is shown under the graph. In patients who stopped using oral corticosteroids between time points, a corticosteroid dose of 0 mg/day was used for the subsequent time point
Fig. 4
Fig. 4
Mean changes from week 0 to week 52 in the 25-item National Eye Institute Visual Function Questionnaire total score and 12 subscale scores. Patients with both pre-dose and final observation data were included

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