Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE.

Abstract

BACKGROUND:

Therapies that maintain remission for patients with Crohn's disease are essential. Stable remission rates have been demonstrated for up to 2 years in adalimumab-treated patients with moderately to severely active Crohn's disease enrolled in the CHARM and ADHERE clinical trials.

AIM:

To present the long-term efficacy and safety of adalimumab therapy through 4 years of treatment.

METHODS:

Remission (CDAI <150), response (CR-100) and corticosteroid-free remission over 4 years, and maintenance of these endpoints beyond 1 year were assessed in CHARM early responders randomised to adalimumab. Corticosteroid-free remission was also assessed in all adalimumab-randomised patients using corticosteroids at baseline. Fistula healing was assessed in adalimumab-randomised patients with fistula at baseline. As observed, last observation carried forward and a hybrid nonresponder imputation analysis for year 4 (hNRI) were used to report efficacy. Adverse events were reported for any patient receiving at least one dose of adalimumab.

RESULTS:

Of 329 early responders randomised to adalimumab induction therapy, at least 30% achieved remission (99/329) or CR-100 (116/329) at year 4 of treatment (hNRI). The majority of patients (54%) with remission at year 1 maintained this endpoint at year 4 (hNRI). At year 4, 16% of patients taking corticosteroids at baseline were in corticosteroid-free remission and 24% of patients with fistulae at baseline had healed fistulae. The incidence rates of adverse events remained stable over time.

CONCLUSIONS:

Prolonged adalimumab therapy maintained clinical remission and response in patients with moderately to severely active Crohn's disease for up to 4 years. No increased risk of adverse events or new safety signals were identified with long-term maintenance therapy. (clinicaltrials.gov number: NCT00077779).

• Authors: R Panaccione, J-F Colombel, W J Sandborn, G D'Haens, Q Zhou, P F Pollack, R B Thakkar, A M Robinson
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 38 Issue 10 Pg. 1236-47 (Nov 2013) ISSN: 1365-2036 [Electronic] England
• PMID: 24134498 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 John Wiley & Sons Ltd.

Chemical References

• Anti-Inflammatory Agents
• Antibodies, Monoclonal, Humanized
• Glucocorticoids
• Adalimumab

Topics

• Adalimumab
• Anti-Inflammatory Agents (administration & dosage, adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects, therapeutic use)
• Crohn Disease (drug therapy, physiopathology)
• Double-Blind Method
• Glucocorticoids (administration & dosage, therapeutic use)
• Humans
• Remission Induction
• Severity of Illness Index
• Time Factors
• Treatment Outcome