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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2018.1
- 수록면
- 83 - 89 (7page)
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초록· 키워드
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Background/Aims: Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited. Methods: Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital,India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing scheduleof 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8. The clinical response andremission were assessed at week 8 using Mayo score. Results: A total of 29 patients (62.1% male; mean age, 34.9 ± 9.7 years)with moderate-to-severe steroid-refractory active UC (mean disease duration, 6.3±5.1 years; pancolitis in 9 patients [31.1%];left-sided colitis in 20 patients [68.9%]) were treated with the Exemptia induction dosing schedule. The mean Mayo score at presentation was 8.2±1.4. At week 8, clinical response was observed in 7 patients (24.1%), whereas clinical remission was observed only in 1 patient (3.5%). Among the non-responders (n=21), 4 patients required colectomy, 1 died, 1 was lost to follow-up, 10 were offered fecal microbiota transplant, 3 were administered infliximab, and 2 patients were administered cyclosporineand tacrolimus, respectively. Four patients (13.8%) developed extrapulmonary tuberculosis. Conclusions: The adalimumab biosimilar Exemptia has limited efficacy for the attainment of clinical response and remission in moderate-to-severe steroid-refractory UC, with a significant risk of acquisition or reactivation of tuberculosis in developing countries such as India.
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참고문헌 (28)
참고문헌 신청
Rubin DT / 2009 / Impact of ulcerative colitis from patients' and physicians'perspectives: results from the UC. NORMAL survey / Inflamm Bowel Dis 15:581~588
Travis SP / 1996 / Predicting outcome in severe ulcerative colitis / Gut 38:905~910
Danese S / 2008 / Biological agents for ulcerative colitis: hypes and hopes / Med Res Rev 28:201~218
Rutgeerts P / 2005 / Infliximab for induction and maintenance therapy for ulcerative colitis / N Engl J Med 353:2462~2476
Peyrin-Biroulet L / 2007 / Adalimumab induction therapy for ulcerative colitis with intolerance or lost response to infliximab: an open-label study / World J Gastroenterol 13:2328~2332
Travis SP / 1996 / Predicting outcome in severe ulcerative colitis / Gut 38:905~910
Danese S / 2008 / Biological agents for ulcerative colitis: hypes and hopes / Med Res Rev 28:201~218
Rutgeerts P / 2005 / Infliximab for induction and maintenance therapy for ulcerative colitis / N Engl J Med 353:2462~2476
Peyrin-Biroulet L / 2007 / Adalimumab induction therapy for ulcerative colitis with intolerance or lost response to infliximab: an open-label study / World J Gastroenterol 13:2328~2332
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