Assessment of efficacy of infliximab, Azathioprine, or combination therapy for Crohn's disease

Abstract

Background: The present study was conducted for assessing the efficacy of Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease.Materials and Methods: A total of 60 patients with confirmed diagnosis of Crohn’s Disease were enrolled. Complete demographic and clinical details of all the subjects was recorded. Random division of all the patients was done into three study groups as follows: Group 1: Azathioprine group, Group 2: Infliximab group and Group 3: Combined therapy. Oral mesalamine was continued at a stable dose. Systemic corticosteroids could be initiated with the dose maintained, increased, or decreased until week 14. The primary efficacy end point was the rate of corticosteroid-free clinical remission at week 26; the rates of corticosteroid-free clinical remission at other time points were secondary efficacy end points. All the results were recorded in Microsoft excel sheet and were analysed by SPSS software.Results: Mean age of the patients of the Azathioprine group, Infliximab group and Combined therapy group was 43.2 years, 40.7 years and 41.6 years respectively. Major proportion of the subjects of all the study groups were males. Patients with corticosteroid free clinical remission was similar in all the three groups. Patients who received systemic corticosteroids during therapy was also similar in all the three groups. Nausea, vomiting, abdominal pain, worsening of disease, fatigue, headache and arthralgia were the commonly encountered adverse events.Conclusion: In Crohn’s disease patients, infliximab monotherapy and combination therapy with infliximab plus azathioprine, in comparison to azathioprine alone, causes enhanced rates of corticosteroid-free clinical remission.