ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2382

Real-World Safety and Effectiveness of Adalimumab in Patients with Juvenile Idiopathic Arthritis: Results from a Post-Marketing Surveillance in Japan

Syuji Takei1, Naomi Iwata2, Ichiro Kobayashi3,4, Toru Igarashi5, Yoko Yoshinaga6, Naoko Matsubara7, Naomi Sunaga8, Ayumi Ito7 and Shumpei Yokota9, 1Department of Pediatrics, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan, 2Department of Immunology and Infectious Diseases, Aichi Children’s Health and Medical Center, Obu, Japan, 3Department of Allergy and Rheumatology, Chiba Children’s Hospital, Sapporo, Japan, 4Hokkaido University, Sapporo, Japan, 5Nippon Medical School, Tokyo, Japan, 6Evidence solution, Medical Communications, Medical, AbbVie GK, Tokyo, Japan, 7Medical, AbbVie GK, Tokyo, Japan, 8AbbVie GK, Tokyo, Japan, 9Fuji Toranomon Orthopedic Hospital, Gotemba, Japan

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Date: Tuesday, October 23, 2018

Title: Pediatric Rheumatology – Clinical Poster III: Juvenile Idiopathic Arthritis and Uveitis

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:

The safety and efficacy of adalimumab (an anti-TNF-α antibody) treatment in patients with JIA have been demonstrated in clinical trials. This study was conducted to investigate the safety and effectiveness of adalimumab in patients with JIA in real-world settings in Japan.

Methods:

This all-case post-marketing surveillance (NCT01412021) was conducted at 108 centers in Japan. All patients receiving adalimumab treatment for JIA affecting multiple joints were enrolled between July 1, 2011 and February 26, 2016 and observed for 24 weeks and 1-/2-year follow-ups. The primary endpoint was incidence of adverse drug reactions (ADRs) and secondary endpoint was DAS28-4/ESR remission (<2.6) rate at each study time point.

Results:

Of 375 patients enrolled, 356 were included in the safety cohort (Table 1). Adalimumab was administered at a dose of 20 mg every 2 weeks in 65 of 72 patients weighing 15 kg–<30 kg and at a dose of 40 mg in 236 of 240 patients weighing ≥30 kg. Mean (standard deviation) treatment duration was 159.0 (31.2) days and number of administration was 11.3 (3.8) times. Treatment was discontinued in 44 (12.4%) patients with the most common reason being ineffectiveness in 28 (7.9%), and the second reason as adverse event in 9 (2.5%) patients. Overall, 174 ADRs were reported in 106 (29.8%) patients (Table 2). No cases of malignancy were reported during the study and at the 1- and 2-year follow-ups. Incidence of ADRs gradually decreased from treatment initiation over time (duration [weeks], %: 0–4, 12.6%; 5–8, 7.1%; 9–12, 4.3%; 13–16, 2.4%; 17–20, 1.9%). Incidence of ADRs was numerically higher in children aged< 15 years (34.6% [79/228]) than in patients aged ≥15 years (21.1% [27/128]) and in those weighing 15–<30 kg (47.2% [34/72]) than in those <15 kg (12.5% [1/8]) and ≥30 kg (27.5% [66/240]). Self-administration errors were reported in 2 (0.8%) patients. In the effectiveness population (n=205), the DAS28-4/ESR remission rate increased from 22.4% (38/170 patients) at baseline to 75.0% (114/152 patients) at 24 weeks (Figure 1).

Conclusion:

In patients with JIA, adalimumab treatment was well tolerated with acceptable safety and effectiveness in real-world settings.


Disclosure: S. Takei, Ayumi, Taisho-Toyama, Sanofi, Tanabe-Mitsubishi, Abbvie, Novartis, Bristol-Myers Squibb, Chugai, Esai, Ono, 5; N. Iwata, Mitsubishi Tanabe Pharma Corporation, Eisai Co, AbbVie GK and Bristol-Myers Squibb, 5; I. Kobayashi, None; T. Igarashi, None; Y. Yoshinaga, AbbVie GK, 1, 3; N. Matsubara, AbbVie GK, 1, 3; N. Sunaga, AbbVie GK, 1, 3; A. Ito, AbbVie GK, 1, 3; S. Yokota, Chugai Pharma, 7.

To cite this abstract in AMA style:

Takei S, Iwata N, Kobayashi I, Igarashi T, Yoshinaga Y, Matsubara N, Sunaga N, Ito A, Yokota S. Real-World Safety and Effectiveness of Adalimumab in Patients with Juvenile Idiopathic Arthritis: Results from a Post-Marketing Surveillance in Japan [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/real-world-safety-and-effectiveness-of-adalimumab-in-patients-with-juvenile-idiopathic-arthritis-results-from-a-post-marketing-surveillance-in-japan/. Accessed .

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