Safety and effectiveness of adalimumab in Japanese patients with juvenile idiopathic arthritis: Results from a real-world postmarketing study

Abstract

Objectives

This study was conducted to assess the real-world safety and effectiveness of adalimumab in patients with juvenile idiopathic arthritis (JIA).

Methods

In this all-case, postmarketing surveillance study (NCT01412021) conducted in Japan, patients receiving adalimumab for JIA affecting multiple joints were observed for 24 weeks. The safety (adverse drug reactions [ADRs]/serious ADRs) and effectiveness (4-variable Disease Activity Score in 28 joints using erythrocyte sedimentation rate [DAS28-4/ESR] remission rate) were assessed.

Results

In the safety population (n = 356), 90.3% (65/72; weight, ≥15–<30 kg) of patients received adalimumab 20 mg every 2 weeks (q2w) and 98.3% (236/240; weight ≥30 kg) received 40 mg q2w. Incidence of ADRs and serious ADRs was 29.8% (106/356) and 3.4% (12/356), respectively. Incidence of ADRs was significantly higher in patients aged <15 years vs. ≥15 years (34.6% vs. 21.1%, p = .0072), those with comorbidities vs. without (38.3% vs. 25.7%, p = .0155), and those receiving dose <40 mg q2w vs. ≥40 mg q2w (38.8% vs. 26.9%, p = .0418). DAS28-4/ESR remission rate improved from 21.7% (36/166) at baseline to 74.7% (112/150) at week 24.

Conclusions

Adalimumab was well tolerated and had acceptable safety and effectiveness in patients with JIA in the real-world setting.

Keywords:

• Adalimumab
• anti-TNF therapy
• Japanese
• juvenile idiopathic arthritis
• postmarketing surveillance

Conflict of interest

Syuji Takei reports personal fees from Ayumi, Taisho-Toyama, Sanofi, Mitsubishi Tanabe Pharma Corporation, AbbVie GK, Novartis, Bristol-Myers Squibb, Chugai, Eisai, and Ono (consultancy and lecture fees in relation to clinical drug development programs for bDMARDs and csDMARDs in the treatment of JIA). Naomi Iwata reports personal fees from Mitsubishi Tanabe Pharma Corporation, Eisai, AbbVie GK, and Bristol-Myers Squibb (consultancy and lecture fees in relation to clinical drug development programs for serving on a scientific advisory board and speaking). Ichiro Kobayashi, Toru Igarashi and Shumpei Yokota report no conflicts of interest. Naoko Matsubara, Naomi Sunaga, and Ayumi Ito are employees of AbbVie GK and may receive stock and/or stock options from AbbVie GK. Yoko Yoshinaga was an employee of AbbVie GK at the time of the study and during publication development and may have received stock and/or stock options from AbbVie GK.

Additional information

Funding

This work was funded by AbbVie Inc. AbbVie participated in the study design, research, data collection, and analysis and interpretation of data, as well as in the writing, review, and approval of the publication. Medical writing support was provided by Deepali Garg, MBBS, PGDHA, and Maribeth Bogush, PhD, of Cactus Communications and funded by AbbVie GK.