Safety of Adalimumab and Predictors of Adverse Events in 1693 Japanese Patients with Crohn’s Disease
| Autor: | Hidenori Hase, Tsuyoshi Tsuchiya, Haruhiko Ogata, Yasuhiko Shinmura, Mamoru Watanabe, Motohiro Okayasu, Toshiyuki Matsui, Toshifumi Hibi |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Crohn’s disease
Adult Male medicine.medical_specialty Tuberculosis Injections Subcutaneous Anti-Inflammatory Agents Drug Administration Schedule 03 medical and health sciences 0302 clinical medicine Crohn Disease Japan Internal medicine Adalimumab Product Surveillance Postmarketing Medicine Humans Prospective Studies Adverse effect Prospective cohort study 030203 arthritis & rheumatology Crohn's disease business.industry Gastroenterology General Medicine Induction Chemotherapy Middle Aged medicine.disease Crohn's Disease Activity Index Surgery post-marketing study Logistic Models Treatment Outcome Concomitant 030211 gastroenterology & hepatology Original Article Female business Adverse drug reaction medicine.drug |
| Zdroj: | Journal of Crohn's & Colitis |
| ISSN: | 1876-4479 1873-9946 |
| Popis: | Background and Aims: Data from an all-cases post-marketing study were used to evaluate the safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease [CD]. Methods: Patients received adalimumab for 24 weeks. Data from all patients [ n = 1693] were used for the safety assessment. Data from patients with CD activity index [CDAI] ≥ 150 at baseline were used for the effectiveness assessment. Results: The most frequent serious adverse drug reaction [ADR] was infection and infestations [6.6 events/100 patient-years]. The risk of serious infections increased in patients who had a history of malignancy and those with concomitant corticosteroid use. Of 415 patients who had switched from another anti-tumour necrosis factor alpha [TNFα] agent to adalimumab due to ADRs, 7.2% discontinued due to ADRs to adalimumab. Ten of 13 patients with a history of tuberculosis [TB] received prophylactic medication, and none developed TB. TB developed in one patient with no history of TB or anti-TB prophylaxis. Remission rates were 41.3% and 32.4% at 4 and 24 weeks, respectively. Remission rates did not differ between patients with and without concomitant use of immunomodulators. Predictive variables for increased effectiveness were CDAI ≤ 220 and disease duration of ≤ 2 years. Perianal lesions and loss of response to previous anti-TNFα agents affected effectiveness. Conclusions: The most frequent serious ADR was infection. Adalimumab significantly reduced disease activity, without any unexpected ADRs. Development of active TB during adalimumab therapy can be prevented through TB screening and prophylaxis. In patients who switched from another anti-TNFα agent to adalimumab due to ADRs, adalimumab was well tolerated. |
| Databáze: | OpenAIRE |
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