Dataset Information

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

ABSTRACT: 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].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.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 [TNF?] 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-TNF? agents affected effectiveness.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-TNF? agent to adalimumab due to ADRs, adalimumab was well tolerated.

SUBMITTER: Ogata H

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

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Ogata Haruhiko H Watanabe Mamoru M Matsui Toshiyuki T Hase Hidenori H Okayasu Motohiro M Tsuchiya Tsuyoshi T Shinmura Yasuhiko Y Hibi Toshifumi T

Journal of Crohn's & colitis 20160309 9

<h4>Background and aims</h4>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].<h4>Methods</h4>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.<h4>Results</h4>The most frequent serious adverse drug reaction [ADR] was in ...[more]

PMID: 26961546

Similar Datasets

Project description:IntroductionCrohn's disease (CD) is a chronic and progressive disease in which the long-term management is important. This study sought to assess treatment persistence and dose escalation in the maintenance phase with adalimumab (ADA) or infliximab (IFX) in a Japanese real-world setting.MethodsA retrospective analysis was conducted using the Japan Medical Data Center database. CD patients with either ADA or IFX prescriptions between January 2012 and February 2015 were included. Outcomes of interest were (1) failure in the induction phase (defined as switch or discontinuation) and (2) persistence in the maintenance phase (defined as the absence of switch or discontinuation over 12 months since maintenance initiation).ResultsOverall, 133 patients (53 ADA; 80 IFX) were included. Of them, treatment failed in 26 patients (19.6%) in the induction phase. During the induction phase, there was a trend towards fewer treatment failures with ADA than IFX (88.7% vs. 75.0%; p = 0.051). Of those who completed induction, 64 patients (33 ADA; 31 IFX) had at least 12 months of valid insurance enrolment after the initiation of maintenance and 13 (5 ADA; 8 IFX) had either switch or discontinuation within 12 months after the initiation of maintenance. Probabilities of switch or discontinuation over 12 months after the maintenance date were 15.2% and 20.9% for ADA and IFX groups, respectively (p-log rank = 0.7764).ConclusionJapanese patients have a high primary response to anti-tumor necrosis factor therapy in the real-world setting, in line with the results of clinical trials. This initial therapeutic advantage can be lost during the maintenance phase, leading to dose escalation, treatment switch, or discontinuation. This study suggests that those events occurred in comparable proportions of patients treated with either ADA or IFX. However, these findings should be considered with caution given the retrospective nature and small size of the study.FundingAbbvie GK, Tokyo, Japan.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets