Infliximab, azathioprine, or combination therapy for Crohn's disease

BACKGROUND: The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for Crohn's disease are unknown. METHODS: In this randomized, double-blind trial, we evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy, and the two drugs combined in 508 adults with moderate-to-severe Crohn's disease who had not undergone previous immunosuppressive or biologic therapy. Patients were randomly assigned to receive an intravenous infusion of 5 mg of infliximab per kilogram of body weight at weeks 0, 2, and 6 and then every 8 weeks plus daily oral placebo capsules; 2.5 mg of oral azathioprine per kilogram daily plus a placebo infusion on the standard schedule; or combination therapy with the two drugs. Patients received study medication through week 30 and could continue in a blinded study extension through week 50. RESULTS: Of the 169 patients receiving combination therapy, 96 (56.8%) were in corticosteroid-free clinical remission at week 26 (the primary end point), as compared with 75 of 169 patients (44.4%) receiving infliximab alone (P = 0.02) and 51 of 170 patients (30.0%) receiving azathioprine alone (P<0.001 for the comparison with combination therapy and P = 0.006 for the comparison with infliximab). Similar numerical trends were found at week 50. At week 26, mucosal healing had occurred in 47 of 107 patients (43.9%) receiving combination therapy, as compared with 28 of 93 patients (30.1%) receiving infliximab (P = 0.06) and 18 of 109 patients (16.5%) receiving azathioprine (P<0.001 for the comparison with combination therapy and P = 0.02 for the comparison with infliximab). Serious infections developed in 3.9% of patients in the combination-therapy group, 4.9% of those in the infliximab group, and 5.6% of those in the azathioprine group. CONCLUSIONS: Patients with moderate-to-severe Crohn's disease who were treated with infliximab plus azathioprine or infliximab monotherapy were more likely to have a corticosteroid-free clinical remission than those receiving azathioprine monotherapy. (ClinicalTrials.gov number, NCT00094458.) Copyright

...It is unclear as to whether patients should be treated with solely anti-TNF monotherapy or with concomitant immunosuppression. The balance of argument pivots on the need to optimise anti-TNF therapy and the increased risk of complications associated with the latter. The recent SONIC study evaluated as primary end-point the efficacy at 26 weeks of IFX monotherapy, AZA monotherapy and the two drugs combined in 508 patients with active Crohn's disease who had not previously undergone immunosuppressive or biological therapy. On combination therapy, 56.8% were in steroid-free remission at week 26, compared with 44.4% of patients on IFX montherapy (p=0.02), and 30.0% on AZA alone (p<0.001). A similar trend was reported at week 50. The study did not address longer-term efficacy, safety, cost-issues, or withdrawal strategies, nor identify key prognostic factors for response to AZA alone, all critical issues in clinical practice....

Keywords (3)

Infliximab, azathioprine, or combination therapy for Crohn's disease,10.1056/NEJMoa0904492,New England Journal of Medicine,Jean Frédéric Colombel,Will

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Phase I Clinical Trial of Smad7 Knockdown Using Antisense Oligonucleotide in Patients With Active Crohn's Disease

RP TLC ASSAY OF THE LIPOPHILICITY OF NEW AZATHIOPRINE ANALOGS

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