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.

• Authors: Syuji Takei, Naomi Iwata, Ichiro Kobayashi, Toru Igarashi, Yoko Yoshinaga, Naoko Matsubara, Naomi Sunaga, Ayumi Ito, Shumpei Yokota
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 31 Issue 2 Pg. 421-430 (Mar 2021) ISSN: 1439-7609 [Electronic] England
• PMID: 32340508 (Publication Type: Journal Article)

Chemical References

• Antirheumatic Agents
• Adalimumab

Topics

• Adalimumab (adverse effects, therapeutic use)
• Adolescent
• Adult
• Aged
• Antirheumatic Agents (adverse effects, therapeutic use)
• Arthritis, Juvenile (blood, drug therapy)
• Blood Sedimentation
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Humans
• Japan
• Male
• Middle Aged
• Product Surveillance, Postmarketing
• Treatment Outcome