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Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn's disease.
Aliment Pharmacol Ther. 2020 06; 51(11):1031-1038.AP

Abstract

BACKGROUND

Biologic therapies in patients with Crohn's disease often yield low clinical and endoscopic remission rates. After multiple failed therapies, combining two biologic therapies is possibly the sole medical alternative to recurrent surgery. However, data on this approach are limited.

AIMS

To assess the efficacy and safety of concomitant use of two biologic therapies in the largest cohort to date of refractory Crohn's disease patients.

METHODS

Data were extracted from Crohn's disease patients started on dual biologic therapy at two referral centres. Biologics utilised include infliximab, adalimumab, vedolizumab, ustekinumab, certolizumab and golimumab. The primary outcome was endoscopic improvement (>50% reduction in Simplified Endoscopic Score-Crohn's disease [SES-CD] or explicitly stated). Endoscopic remission (SES-CD < 3 or stated), clinical response (Crohn's disease-patient-reported outcome-2 score [PRO2] reduced by 8), clinical remission (PRO2 < 8), and C-reactive protein (CRP) were also assessed.

RESULTS

A total of 22 patients with 24 therapeutic trials of dual biologic therapy were identified. The majority of patients had prior surgical resections (91%), stricturing (59%) or penetrating (36%) phenotype, and perianal fistulas (50%). Median number of prior failed biologics was 4. Endoscopic improvement occurred in 43% of trials and 26% achieved endoscopic remission. Fifty per cent had clinical response and 41% achieved clinical remission. There were significant post-treatment reductions in median SES-CD (14.0 [12.0-17.5] to 6.0 [2.5-8.0], P = 0.0005], PRO-2 (24.1 [20.3-27.0] to 13.4 [4.6-21.8], P = 0.002] and CRP (17.0 [11.0-24.0] to 9.0 [4.0-14.0], P = 0.02). Presence of perianal fistulas decreased from 50% to 33%. Adverse events occurred in 13% of trials.

CONCLUSION

Dual biologic therapy was associated with clinical, biomarker and endoscopic improvements in selected patients with refractory Crohn's disease who failed multiple biologics. Further studies are needed to validate this approach.

Authors+Show Affiliations

UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA.Faculty of Health Science, Western University, London, ON, Canada.UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA.UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA.UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA.UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA.UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA.UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA.UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA.University of Calgary Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, Calgary, AB, Canada.UCSD Inflammatory Bowel Disease Center, Division of Gastroenterology, Department of Medicine, La Jolla, CA, USA. Jill Roberts Center for IBD, Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, NY, USA.

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32329532

Citation

Yang, Edward, et al. "Efficacy and Safety of Simultaneous Treatment With Two Biologic Medications in Refractory Crohn's Disease." Alimentary Pharmacology & Therapeutics, vol. 51, no. 11, 2020, pp. 1031-1038.
Yang E, Panaccione N, Whitmire N, et al. Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn's disease. Aliment Pharmacol Ther. 2020;51(11):1031-1038.
Yang, E., Panaccione, N., Whitmire, N., Dulai, P. S., Vande Casteele, N., Singh, S., Boland, B. S., Collins, A., Sandborn, W. J., Panaccione, R., & Battat, R. (2020). Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn's disease. Alimentary Pharmacology & Therapeutics, 51(11), 1031-1038. https://doi.org/10.1111/apt.15719
Yang E, et al. Efficacy and Safety of Simultaneous Treatment With Two Biologic Medications in Refractory Crohn's Disease. Aliment Pharmacol Ther. 2020;51(11):1031-1038. PubMed PMID: 32329532.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn's disease. AU - Yang,Edward, AU - Panaccione,Nicola, AU - Whitmire,Natalie, AU - Dulai,Parambir S, AU - Vande Casteele,Niels, AU - Singh,Siddharth, AU - Boland,Brigid S, AU - Collins,Angelina, AU - Sandborn,William J, AU - Panaccione,Remo, AU - Battat,Robert, Y1 - 2020/04/24/ PY - 2020/01/18/received PY - 2020/02/09/revised PY - 2020/03/21/accepted PY - 2020/4/25/pubmed PY - 2020/11/20/medline PY - 2020/4/25/entrez SP - 1031 EP - 1038 JF - Alimentary pharmacology & therapeutics JO - Aliment Pharmacol Ther VL - 51 IS - 11 N2 - BACKGROUND: Biologic therapies in patients with Crohn's disease often yield low clinical and endoscopic remission rates. After multiple failed therapies, combining two biologic therapies is possibly the sole medical alternative to recurrent surgery. However, data on this approach are limited. AIMS: To assess the efficacy and safety of concomitant use of two biologic therapies in the largest cohort to date of refractory Crohn's disease patients. METHODS: Data were extracted from Crohn's disease patients started on dual biologic therapy at two referral centres. Biologics utilised include infliximab, adalimumab, vedolizumab, ustekinumab, certolizumab and golimumab. The primary outcome was endoscopic improvement (>50% reduction in Simplified Endoscopic Score-Crohn's disease [SES-CD] or explicitly stated). Endoscopic remission (SES-CD < 3 or stated), clinical response (Crohn's disease-patient-reported outcome-2 score [PRO2] reduced by 8), clinical remission (PRO2 < 8), and C-reactive protein (CRP) were also assessed. RESULTS: A total of 22 patients with 24 therapeutic trials of dual biologic therapy were identified. The majority of patients had prior surgical resections (91%), stricturing (59%) or penetrating (36%) phenotype, and perianal fistulas (50%). Median number of prior failed biologics was 4. Endoscopic improvement occurred in 43% of trials and 26% achieved endoscopic remission. Fifty per cent had clinical response and 41% achieved clinical remission. There were significant post-treatment reductions in median SES-CD (14.0 [12.0-17.5] to 6.0 [2.5-8.0], P = 0.0005], PRO-2 (24.1 [20.3-27.0] to 13.4 [4.6-21.8], P = 0.002] and CRP (17.0 [11.0-24.0] to 9.0 [4.0-14.0], P = 0.02). Presence of perianal fistulas decreased from 50% to 33%. Adverse events occurred in 13% of trials. CONCLUSION: Dual biologic therapy was associated with clinical, biomarker and endoscopic improvements in selected patients with refractory Crohn's disease who failed multiple biologics. Further studies are needed to validate this approach. SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/32329532/Efficacy_and_safety_of_simultaneous_treatment_with_two_biologic_medications_in_refractory_Crohn's_disease_ DB - PRIME DP - Unbound Medicine ER -