Safety of Adalimumab and Predictors of Adverse Events in 1693 Japanese Patients with Crohn's Disease.

ABSTRACT:

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

SUBMITTER: Ogata H 

PROVIDER: S-EPMC5007524 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature