Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance

Shiro Nakamura; Teita Asano; Hiroaki Tsuchiya; Kanami Sugimoto; Yuya Imai; Seiji Yokoyama; Yasuo Suzuki

doi:10.5217/ir.2021.00032

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자료유형: 학술저널

저자정보: Shiro Nakamura (Department of Internal Medicine II Osaka Medical College Hospital) Teita Asano (Janssen Pharmaceutical K.K. Tokyo) Hiroaki Tsuchiya (Janssen Pharmaceutical K.K. Tokyo) Kanami Sugimoto (Janssen Pharmaceutical K.K. Tokyo) Yuya Imai (Janssen Pharmaceutical K.K. Tokyo) Seiji Yokoyama (Janssen Pharmaceutical K.K. Tokyo) Yasuo Suzuki (Inflammatory Bowel Disease Center Toho University Sakura Medical Center)

저널정보: 대한장연구학회 Intestinal research Intestinal research Vol.20 No.3

발행연도: 2022.7

수록면: 329 - 341 (13page)

DOI: 10.5217/ir.2021.00032

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Background/Aims: Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in patients with UC in Japan. We present an interim report of the ongoing PMS.Methods: Patients received 200 mg of subcutaneous GLM at week 0, 100 mg at week 2, and 100 mg 4 weekly thereafter. The safety analysis set included 392 patients with UC, and the effectiveness analysis set 387 patients. Safety and effectiveness were assessed at week 6.Results: Adverse drug reactions (ADRs) were reported in 8.2% (32/392) and serious ADRs in 4.6% (18/392). The most frequent ADRs were infection and infestation (3.3%), with herpes zoster being the most common. ADRs were significantly higher in patients with concomitant corticosteroid use (odds ratio [OR], 3.45; 95% confidence interval [CI], 1.40?9.68). No significant difference in ADR incidence was observed between patients aged ≥65 and <65 years (OR, 1.23; 95% CI, 0.35?3.47). Six-week effectiveness of GLM was confirmed by a decrease in the partial Mayo score (?2.3; 95% CI, ?2.6 to ?2.1) and C-reactive protein levels (?0.64; 95% CI, ?0.92 to ?0.36), including in the biologics-experienced population.Conclusions: The safety and effectiveness of GLM at week 6 in a real-world setting were demonstrated in patients with UC in Japan. ADR patterns were consistent with previous reports with no new safety signals. Concomitant corticosteroid use may be associated with increased ADR incidence. The final results of the ongoing PMS are necessary for further evaluation.

#Golimumab #Colitis #ulcerative #Product surveillance #postmarketing #Safety and effectiveness

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Shiro Nakamura

소속기관 Department of Internal Medicine II Osaka Medical College Hospital

주요연구분야 의약학 > 임상의학 > 내과학

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Teita Asano