Remission maintained by monotherapy after biological + immunosuppressive combination for Crohn's disease in clinical practice

• Published in: Journal of gastroenterology and hepatology Vol. 31; no. 1; pp. 112 - 118
• Main Authors: Ampuero, Javier, Rojas-Feria, María, Castro-Fernández, Manuel, Millán-Lorenzo, Marina, Guerrero-Jiménez, Pedro, Romero-Gómez, Manuel
• Format: Journal Article
• Language: English
• Published: Australia Blackwell Publishing Ltd 01-01-2016
• Subjects: Adolescent; Adult; Age Factors; Azathioprine - administration & dosage; biological therapy; Biomarkers - blood; C-Reactive Protein - analysis; Crohn Disease - diagnosis; Crohn Disease - drug therapy; Crohn's disease; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Female; Gastrointestinal Agents - administration & dosage; Humans; Immunosuppressive Agents - administration & dosage; immunosuppressive therapy; Induction Chemotherapy; inflammatory bowel disease; Infliximab - administration & dosage; Maintenance Chemotherapy; Male; Recurrence; relapse; Remission Induction; Retrospective Studies; Severity of Illness Index; Treatment Outcome; Young Adult; immunosuppressive therapy; Crohn's disease; relapse; biological therapy; inflammatory bowel disease
• ISSN: 0815-9319; 1440-1746
• DOI: 10.1111/jgh.13039

Background and Aim:
The optimal time to withdraw combined biological + immunosuppressive therapy in Crohn's disease is debated. Following remission of 6 months with the combined therapy, we assessed the efficacy of monotherapy in maintaining remission.
Methods:
Crohn's disease patients (n = 75) were retrospectively selected from clinical records for having achieved remission within 6 months of receiving combined biological + immunosuppressive therapy. Treatment continued for a further year with one or the other of the combination drugs withdrawn. Clinical remission was defined as Crohn's Disease Activity Index (CDAI) < 150 and endoscopic remission as CDAI < 150 + absence of mucosal lesions + no signs of active inflammation on ileocolonoscopy. Crohn's disease relapse was defined as CDAI > 250.
Results:
Twenty‐eight percent (21/75) patients were relapsers. Withdrawal of biological therapy was more frequent than immunosuppressive (73.3% vs 26.7%) with no significant differences in relapse rates (30.9% vs 20%; P = 0.401). Endoscopic remission was more accurate than clinical remission (relapse rates: 10.5% vs 33.9%; P = 0.05). C‐reactive‐protein was higher in relapsers (19.2 ± 23.7 mg/L vs 2.5 ± 4.7 mg/L; P = 0.009). Multivariate analysis indicated C‐reactive protein > 5 mg/L (odds ratios [OR]: 30.12; 95% confidence intervals [95% CI]: 5.91–153.38; P = 0.0001) and younger age at diagnosis (OR: 1.10; 95% CI: 1.01–1.19; P = 0.047) as independent factors predicting relapse. There was a strong trend toward a protective effect of endoscopic remission (OR: 0.17; 95% CI: 0.02–1.22; P = 0.077).
Conclusion:
A subgroup of Crohn's disease patients treated with combination therapy can be identified (C‐reactive protein < 5 mg/L, endoscopic remission, and older age at Crohn's disease diagnosis) who would continue in remission despite cessation of the biological (expensive) component of the combination therapy.