Nagesh Kamat1, Saurabh Kedia1, Uday C Ghoshal2, Abhimanyu Nehra2, Govind Makharia1, Ajit Sood3, Vandana Midha3, Varun Gupta4, Gourdas Choudhuri4, Vineet Ahuja5. 1. Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, 110 029, India. 2. Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India. 3. Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India. 4. Department of Gastroenterology, Fortis Memorial Research Institute, Gurugram, 122 002, India. 5. Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, 110 029, India. vineet.aiims@gmail.com.
Abstract
BACKGROUND: Adalimumab has emerged as a useful drug for treating patients with Crohn's disease (CD) and ulcerative colitis (UC), not responding to conventional therapy. There is limited data on effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease (IBD). METHODS: Patients with IBD who received at least one dose of adalimumab biosimilar from October 2015 to February 2018 were retrospectively included in this multicenter data analysis. Its effectiveness in inducing and maintaining clinical remission at 8, 26, and 52 weeks for CD and UC and safety profile of the drug was studied. RESULTS: Seventy patients (49 CD; 21 UC) with a median age of 39 (range 13-73) years, male predominance (64.3%), and median (IQR) disease duration of 72 (33-104) months were included. Adalimumab biosimilar was effective in inducing remission (at 8 weeks) in 46.9% and 52.4% patients with CD and UC, respectively, of whom 32.7% and 33.3% (three fourths of remitters) maintained remission over 1 year, respectively. Twenty (28.6%) patients experienced adverse events; seven (10%) were serious of whom three had developed tuberculosis. CONCLUSIONS: Adalimumab biosimilar in usual clinical practice is safe and effective in inducing and maintaining remission in Indian patients with IBD. Steroid-free clinical remission was observed in one third of patients with UC and CD at 1 year of therapy. Graphical Abstract.
BACKGROUND:Adalimumab has emerged as a useful drug for treating patients with Crohn's disease (CD) and ulcerative colitis (UC), not responding to conventional therapy. There is limited data on effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease (IBD). METHODS:Patients with IBD who received at least one dose of adalimumab biosimilar from October 2015 to February 2018 were retrospectively included in this multicenter data analysis. Its effectiveness in inducing and maintaining clinical remission at 8, 26, and 52 weeks for CD and UC and safety profile of the drug was studied. RESULTS: Seventy patients (49 CD; 21 UC) with a median age of 39 (range 13-73) years, male predominance (64.3%), and median (IQR) disease duration of 72 (33-104) months were included. Adalimumab biosimilar was effective in inducing remission (at 8 weeks) in 46.9% and 52.4% patients with CD and UC, respectively, of whom 32.7% and 33.3% (three fourths of remitters) maintained remission over 1 year, respectively. Twenty (28.6%) patients experienced adverse events; seven (10%) were serious of whom three had developed tuberculosis. CONCLUSIONS:Adalimumab biosimilar in usual clinical practice is safe and effective in inducing and maintaining remission in Indian patients with IBD. Steroid-free clinical remission was observed in one third of patients with UC and CD at 1 year of therapy. Graphical Abstract.
Authors: Ruma Rajbhandari; Samantha Blakemore; Neil Gupta; Alma J Adler; Christopher Allen Noble; Sara Mannan; Klejda Nikolli; Alison Yih; Sameer Joshi; Gene Bukhman Journal: World J Gastroenterol Date: 2020-11-21 Impact factor: 5.742
Authors: Martin Wasserbauer; Stepan Hlava; Jiri Drabek; Jan Stovicek; Petra Minarikova; Lenka Nedbalova; Tomas Drasar; Zdena Zadorova; Jiri Dolina; Stefan Konecny; Vladimír Kojecky; Jana Kozeluhova; Pavlina Cernikova; Dita Pichlerova; Barbora Kucerova; Stepan Coufal; Radan Keil Journal: PLoS One Date: 2022-08-08 Impact factor: 3.752