Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: A large-scale post-marketing surveillance (PMS) has been implemented to evaluate the safety and effectiveness on the use of intravenous abatacept (ABT) in Japanese patients with rheumatoid arthritis (RA) as per approval condition.
Methods: This observational study has registered all of the patients intended to be treated with ABT in Japan after its start of marketing in September 2010. Patients were prospectively monitored for adverse events (AEs) for 24 weeks. Disease Activity Score 28-CRP (DAS28-CRP) was calculated at baseline, Weeks 4, 12 and 24 of treatment.
Results: Of 4256 patients treated with ABT between September 2010 and June 2011, the safety and effectiveness were analyzed in 3985 and 3094 patients, respectively. Most of the patients from the safety population had established RA. Their mean age was 61.3 years and mean RA duration was 10.3 years. About 70% of patients had received biologic drug(s) prior to ABT. Methotrexate (MTX) and corticosteroid were used concomitantly in 67.0% and 63.3% of patients, respectively. Adverse drug reactions (ADRs) and serious ADRs occurred in 15.4% and 2.5% of patients, respectively. ADRs in ≥0.5% of patients included upper respiratory tract inflammation (1.2%), herpes zoster (1.0%), bronchitis (0.9%), stomatitis (0.9%), nasopharyngitis (0.9%), abnormal hepatic function tests (0.8%), pyrexia (0.6%), and rash (0.6%). Infections occurred in 5.9%; pneumonia in 28 patients (0.7%), Pneumocystis jirovecii pneumonia in 4 patients (0.1%), tuberculosis in 1 patient (0.03%) and atypical mycobacterial infection in 2 patients (0.05%). Serious infections were reported in 1.0% of patients. ABT was tolerated even in patients who had prior biologics use, there was no statistical difference of the incidence of ADRs or serious ADRs between biologic-naïve and -experienced patients. The incidence of ADRs was numerically lower, although not statistically, in patients using MTX than in patients not using MTX. Multivariate logistic regression analyses showed that age >65 years, body weight <40 kg, hepatic comorbidities, history/presence of respiratory disorders, history of allergies, prior use of tocilizumab, and concomitant use of prednisolone >5 mg/day were risk factors for infections. DAS28-CRP decreased from 4.47 at baseline to 3.25 at Week 24, with significant reductions from baseline as early as Week 4 (P <0.001). The decrease in DAS28-CRP was significantly greater in the biologic-naïve group than in the biologic-experienced group (P <0.001). The mean change in DAS28-CRP from baseline to Week 24 in patients not using MTX (–1.10) was almost same as in patients using MTX (–1.27), although with a statistical difference (P = 0.003). In the biologic-naïve group, the reduction in DAS28-CRP at Week 24 was not statistically different between patients using MTX and not using MTX.
Conclusion: This large-scale PMS program showed that ABT was well tolerated with no new safety concerns and significantly reduced signs and symptoms of Japanese patients with RA treated in real-world settings.
Disclosure:
T. Koike,
Chugai, Mitsubishi-Tanabe, Pfizer, Astellas, Bristol-Myers, UCB, Takeda, Taisyo-Toyama, Eisai, AbbVie, Teijin, and Santen,
8;
M. Harigai,
Abbvie, Astellas, Bristol-Myers, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Santen, Takeda, UCB, and Pfizer,
2,
Abbvie, Bristol-Myers, Chugai, and Janssen,
5,
Abbvie Astellas, Bristol-Myers, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Santen, Takeda, UCB, and Pfizer,
8;
N. Ishiguro,
Astellas, and Bristol-Myers,
2,
Abbvie, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Pfizer, and Takeda,
5,
Abbvie, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Pfizer, and Takeda,
8;
S. Inokuma,
Asahi Kasei, Astellas, Abbvie, Bristol-Myers, Chugai, Eisai, GlaxoSmithKline, Mitsubishi-Tanabe, Pfizer, Takeda, Santen, Teijin, Taisyo-Toyama, Taiho, Daiichi-Sankyo, Kyorin,
8;
J. Ryu,
None;
S. Takei,
Chugai, Eisai, Takeda, and Bristol-Myers,
2,
Chugai, Eisai, Takeda, Abbvie, Astellas, Teijin, Novartis, Pfizer, and Asahi Kasei,
8;
T. Takeuchi,
Abbott, Abbvie, Asahi Kasei, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Pfizer, Sanofi-aventis, Santen, Taisho-Toyama, Takeda, and Teijin,
2,
Asahi Kasei, Abbvie, Daiichi-Sankyo, AstraZeneca, Eli Lilly, Novartis, and Mitsubishi-Tanabe,
5,
Abbott, Astellas, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe, Pfizer, and Takeda,
8;
Y. Tanaka,
Bristol-Myers, MSD, Chugai, Mitsubishi-Tanabe, Astellas, Abbvie, Eisai, and Janssen,
2,
Mitsubishi-Tanabe, Abbvie, Eisai, Chugai, Janssen, Santen, Pfizer, Astellas, Daiichi-Sankyo, GlaxoSmithKline, AstraZeneca, Otsuka, Actelion, Eli Lilly, Nippon Kayaku, UCB, Quintiles Transnational, Ono, and Novartis,
5,
Mitsubishi-Tanabe, Abbvie, Eisai, Chugai, Janssen, Santen, Pfizer, Astellas, Daiichi-Sankyo, GlaxoSmithKline, AstraZeneca, Otsuka, Actelion, Eli Lilly, Nippon Kayaku, UCB, and Quintiles Transnational,
8;
M. Watanabe,
Bristol-Myers Squibb,
3;
H. Yamanaka,
Abbott, Abbvie, Astellas, AstraZeneca, Bristol-Myers, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer, UCB, and Takeda,
2,
Abbott, Abbvie, Astellas, AstraZeneca, Bristol-Myers, Chugai, Eisai, Mitsubishi- Tanabe, Pfizer, UCB, and Takeda,
5,
Abbott, Abbvie, Astellas, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer, UCB, and Takeda,
8.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-effectiveness-of-abatacept-in-3985-japanese-patients-with-rheumatoid-arthritis-japan-all-cases-post-marketing-surveillance/