Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Tacrolimus (TAC) is an immunosuppressive macrolide that blocks T cell activation by specifically inhibiting calcineurin, and it is widely administered following organ transplantation. TAC was approved in Japan for the treatment of rheumatoid arthritis (RA) in 2005. We report here the interim results of Post-marketing surveillance we have been conducting to evaluate the safety and efficacy of TAC adding on to biological disease-modifying anti-rheumatic drugs (DMARDs) in Japanese RA patients who failed to show an adequate response to biological DMARDs in a real clinical setting.
Methods: The observation period of this study was 24 weeks. One hundred and seventy-two patients were included in the safety population and 165 patients were included in the efficacy population. An inadequate response to biological DMARDs was defined as that all of the following conditions were met: Simplified Disease Activity Index (SDAI) >3.3 when TAC was started; Both tender joint count and swollen joint count were the same or increased compared to those at four to eight weeks prior to TAC; Biological DMARDs were used for at least eight weeks prior to TAC. Efficacy was evaluated using the SDAI, DAS28-CRP (Disease Activity Score 28-C-reactive protein), EULAR (European League Against Rheumatism) response criteria. SDAI improvement was defined as SDAI≤11. DAS28-CRP improvement was defined as DAS28-CRP <2.7.
Results:
Mean age was 61.9 years and the mean disease duration was 11.0 years. The mean TAC dose was 1.3 mg during the observation period. Adverse drug reactions (ADRs) occurred in 18 patients and serious ADRs was observed in two patients (Herpes zoster, Myocardial infarction). One patient (age 76) who developed herpes zoster was resolved during the observation period. One patient (age 89) who developed myocardial infarction died on the day when it occurred. SDAI remission rate was 13.3% at week 24, SDAI improvement rate was 58.5% at week 24 and the mean SDAI was decreased from 20.1 at baseline to 11.7 at week 24. DAS28-CRP remission rate was 33.3% at week 24, DAS28-CRP improvement rate was 48.9% at week 24 and the mean DAS28-CRP was decreased from 4.0 at baseline to 2.9 at week 24. Based on EULAR response criteria, moderate or good response rate was 69.8% at week 24.
Conclusion s: TAC is well tolerated and effective when added on to the biological DMARDs in Japanese RA patients who failed to achieve an adequate response to biological DMARDs in a real clinical setting.
Conclusion: TAC is well tolerated and effective when added on to the biological DMARDs in Japanese RA patients who failed to achieve an adequate response to biological DMARDs in a real clinical setting.
Disclosure:
T. Takeuchi,
AbbVie GK, Asahi Kasei Medical K.K, Astellas, Astra Zeneca, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly Japan K.K, Mitsubishi Tanabe Pharma Co, Novartis Pharma K.K,
5,
AbbVie GK, Astellas, Bristol-Myers Squibb K.K, Chugai Pharmaceutical Co,,Ltd., Daiichi-Sankyo Co,,Ltd., , Eisai Co,, Janssen Pharmaceutical K.K, Mitsubishi Tanabe Pharma Co,, Pfizer Japan Inc, Takeda Pharmaceutical Co.,
8,
AbbVie GK, Astellas, Bristol-Myers Squibb K.K, Chugai Pharmaceutical Co,,Ltd., Daiichi-Sankyo Co,,Ltd., , Eisai Co,,Mitsubishi Tanabe Pharma Co,, Pfizer Japan Inc, Takeda Pharmaceutical Co. Santen Pharmaceutical Co., Ltd., Teijin Pharma Ltd., Asahikasei P,
2;
K. Ishida,
Astellas Pharma Inc.,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/post-marketing-surveillance-of-efficacy-and-safety-of-tacrolimus-add-on-therapy-in-japanese-rheumatoid-arthritis-patients-who-failed-to-show-an-adequate-response-to-biological-dmards-interim-analysi/