P466 Real-world effectiveness and safety of golimumab in patients with ulcerative colitis: 52-weeks of post-marketing surveillance data in Japan
Nakamura, S.(1);Asano, T.(2);Tanaka, Y.(3);Sugimoto, K.(4);Yoshigoe, S.(5);Suzuki, Y.(6);
(1)Osaka Medical and Pharmaceutical University, Second Department of Internal Medicine, Osaka, Japan;(2)Janssen Pharmaceutical K.K., Medical Science Liaison Department, Tokyo, Japan;(3)Janssen Pharmaceutical K.K., Statistics & Decision Sciences Department, Tokyo, Japan;(4)Janssen Pharmaceutical K.K., Safety Risk Management Department, Tokyo, Japan;(5)Janssen Pharmaceutical K.K., Immunology- Infectious Diseases & Vaccine Department, Tokyo, Japan;(6)Ginza Central Clinic, Gastroenterology, Tokyo, Japan;
Golimumab (GLM) is an anti-TNF-α drug approved for treating ulcerative colitis (UC). Although its efficacy and safety were well established in clinical trials, real-world evidence was still limited. In the present study, we evaluated 52-week effectiveness and safety of GLM treatment for UC based on post-marketing surveillance data.
The prospective, post-marketing study was conducted in 393 patients from 163 medical facilities. Patients who had been prescribed GLM were enrolled between May 2017 and September 2019 in Japan. In accordance with Japanese indication, patients received subcutaneous injections of GLM, 200 mg at week 0, 100 mg at weeks 2 and 6, followed by 100 mg every 4 weeks. Clinical remission (partial Mayo score ≤2), predictors of remission, adverse drug reactions (ADRs), and predictors of ADR development were determined at week 52.
Of 393 enrolled patients, 391 and 386 were included in safety and efficacy analysis set, respectively (Table 1). Overall, clinical remission in the intention-to-treat population was 13.0%, 53.9%, 52.6%, 48.2%, and 43.3% at baseline (BL) and at week 6, 22, 36, and 52, respectively (Table 2). In biologic naïve group, clinical remission was 9.2%, 59.1%, 61.0%, 52.4%, and 47.0% at BL and week 6, 22, 36, and 52, respectively, while in biologic experienced group, it was 15.8%, 50.0%, 46.4%, 45.0%, and 40.5% at BL and week 6, 22, 36, and 52, respectively. At week 52, clinical remission rate in the patients who concomitantly used corticosteroid (CS) at BL was significantly lower than that in the patients who did not receive CS (p=0.017, 37.3% vs 49.2%) (Fig. 1). No significant difference in remission rate was observed between immunomodulator (IM) users and IM non-users at baseline. From multivariate analysis, concomitant use of CS (p=0.001, odds ratio [OR] =0.488, 95% CI [confidence interval] 0.314-0.759) and partial Mayo remission at BL (p<0.001, OR=4.329, 95% CI 2.056-9.115) were identified as independent factors associated with clinical remission. ADRs occurred in 71 patients (18.2%). The most common ADR was rash, reported in 9 patients (2.3%). Serious ADRs occurred in 40 patients (10.2%). The most frequent serious ADR was UC, reported in 8 patients (2.0%). In multivariate analysis, the presence of comorbidities was associated with ADR incidence (OR=2.000, 95% CI 1.183-3.380).
From the Japanese post-marketing data, the real-world effectiveness of GLM treatment was confirmed in both biologic naïve and experienced populations. Safety profile was generally consistent with previous findings, and no additional safety signals were identified. Concomitant use of CS, but not IM, may be likely to affect outcome of GLM therapy.