Kerri Glassner1, Ayah Oglat2, Antonio Duran3, Pramoda Koduru4, Caroline Perry1, Amanda Wilhite1, Bincy P Abraham1. 1. Division of Gastroenterology, Houston Methodist Hospital, Houston, Texas, USA. 2. Division of Gastroenterology, Vidant Medical Center, Greenville, North Carolina, USA. 3. Division of Cardiology, Ochsner Medical Center, New Orleans, Louisiana, USA. 4. Digestive Disease Specialists, Inc, Oklahoma City, Oklahoma, USA.
Abstract
OBJECTIVE: There are limited data on using more than one biologic or small molecule drug combined to treat patients with inflammatory bowel disease. The aim of our study was to determine the effectiveness and safety of combination biologic use in inflammatory bowel disease. METHODS: We identified patients with Crohn's disease or ulcerative colitis who received treatment with a combination of two biologics or a biologic and a small molecule drug from 2015 to 2019 for persistent disease activity or concomitant rheumatological or dermatological disease. The primary end-point was effectiveness, based on improvements in inflammatory markers, clinical, and endoscopic remission. The secondary end-point was safety. RESULTS: Of the 50 patients treated with combination therapy there were significantly more patients in clinical and endoscopic remission at follow-up compared to baseline (50% vs 14%, P = 0.0018, delta 36%, 95% confidence interval [CI] 0.13-0.53; and 34% vs 6%, P = 0.0039, delta 28%, 95% CI 0.09-0.47), respectively. Median erythrocyte sedimentation rate (17 mm/h vs 13 mm/h, P = 0.002) and C-reactive protein (5.00 mg/dL vs 2.35 mg/dL, P = 0.002) also decreased posttreatment. There were eight serious adverse events and no deaths CONCLUSIONS: Combination biologic therapy appears to be an effective option for patients with refractory inflammatory bowel disease or concomitant autoimmune disease that is inadequately controlled by biologic monotherapy. There was an increased risk of serious infection compared with biologic monotherapy; however, this risk might be minimized by discontinuing immunomodulators prior to initiating combination therapy. Large prospective studies are needed to confirm these findings.
OBJECTIVE: There are limited data on using more than one biologic or small molecule drug combined to treat patients with inflammatory bowel disease. The aim of our study was to determine the effectiveness and safety of combination biologic use in inflammatory bowel disease. METHODS: We identified patients with Crohn's disease or ulcerative colitis who received treatment with a combination of two biologics or a biologic and a small molecule drug from 2015 to 2019 for persistent disease activity or concomitant rheumatological or dermatological disease. The primary end-point was effectiveness, based on improvements in inflammatory markers, clinical, and endoscopic remission. The secondary end-point was safety. RESULTS: Of the 50 patients treated with combination therapy there were significantly more patients in clinical and endoscopic remission at follow-up compared to baseline (50% vs 14%, P = 0.0018, delta 36%, 95% confidence interval [CI] 0.13-0.53; and 34% vs 6%, P = 0.0039, delta 28%, 95% CI 0.09-0.47), respectively. Median erythrocyte sedimentation rate (17 mm/h vs 13 mm/h, P = 0.002) and C-reactive protein (5.00 mg/dL vs 2.35 mg/dL, P = 0.002) also decreased posttreatment. There were eight serious adverse events and no deaths CONCLUSIONS: Combination biologic therapy appears to be an effective option for patients with refractory inflammatory bowel disease or concomitant autoimmune disease that is inadequately controlled by biologic monotherapy. There was an increased risk of serious infection compared with biologic monotherapy; however, this risk might be minimized by discontinuing immunomodulators prior to initiating combination therapy. Large prospective studies are needed to confirm these findings.
Authors: Quazim A Alayo; Aava Khatiwada; Anish Patel; Maria Zulfiqar; Anas Gremida; Alexandra Gutierrez; Richard P Rood; Matthew A Ciorba; George Christophi; Parakkal Deepak Journal: Inflamm Bowel Dis Date: 2021-10-18 Impact factor: 7.290
Authors: Quazim A Alayo; Marc Fenster; Osama Altayar; Kerri L Glassner; Ernesto Llano; Kindra Clark-Snustad; Anish Patel; Lukasz Kwapisz; Andres J Yarur; Benjamin L Cohen; Matthew A Ciorba; Deborah Thomas; Scott D Lee; Edward V Loftus; David I Fudman; Bincy P Abraham; Jean-Frederic Colombel; Parakkal Deepak Journal: Crohns Colitis 360 Date: 2022-02-10
Authors: Laurent Goessens; Jean-Frédéric Colombel; An Outtier; Marc Ferrante; Joao Sabino; Ciaran Judge; Reza Saeidi; Louise Rabbitt; Alessandro Armuzzi; Eugeni Domenech; George Michalopoulos; Anneline Cremer; Francisco Javier García-Alonso; Tamas Molnar; Konstantinos Karmiris; Krisztina Gecse; Joep Van Oostrom; Mark Löwenberg; Klaudia Farkas; Raja Atreya; Davide Giuseppe Ribaldone; Christian Selinger; Frank Hoentjen; Benoit Bihin; Shaji Sebastian; Jean-François Rahier Journal: United European Gastroenterol J Date: 2021-10-25 Impact factor: 4.623