EFFICACY AND SAFETY OF ADALIMUMAB VERSUS INFLIXIMAB IN PATIENTS SUFFERED FROM MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS

Abstract

ABSTRACTObjective: Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the large intestine, usually involving the rectum. During the lastdecade, clinical trials have shown adalimumab (ADA) and infliximab (IFX) to be efficacious in inducing and maintaining remission for moderate tosevere UC refractory to the conventional therapies. The purpose of this study was to compare the efficacy and safety of ADA and IFX for inductionremission in Iraqi patients with moderately to severely active UC.Methods: A total of 50 patients with moderate to severe UC, who were refractory to concurrent treatment with oral corticosteroids and/or immunesuppressants, were randomly assigned in 1:1 ratio to receive either ADA (160/80 mg, subcutaneous) or IFX (5 mg/kg, intravenous) during theinduction phase (8 weeks). Primary efficacy endpoint was clinical remission at week 8. Secondary efficacy endpoints were the clinical response,mucosal healing, subscores indicative of mild disease (rectal bleeding subscore [RBS], physician’s global assessment [PGA] subscore, and stoolfrequency subscore [SFS]). Partial Mayo score was also evaluated in addition to the inflammatory bowel disease questionnaire (IBDQ). Additionalsubgroup analysis was based on the Mayo score, extensive colitis, concomitant medications, high sensitivity C-reactive protein (hs-CRP) level, andpatient weight at baseline. The safety profile was assessed in all enrolled patients.Results: At week 8, 24% of patients receiving ADA were in clinical remission, compared with 28% on IFX (p>0.05). Clinical response was achievedin 48% of patients receiving ADA and 52% of patients on IFX (p>0.05). Mucosal healing was achieved in 40% of patients receiving either ADA orIFX (p>0.05). For the subscores indicative of mild disease (≤1), the patients % of RBS and PGA was significantly higher within IFX group (p<0.05)while the patients % of SFS was significantly higher within ADA group (p<0.05). The proportion of patients achieving clinical remission based on thepartial Mayo score, in addition to IBDQ response index, was not differ significantly between the two groups from week 2 and throughout the study(p>0.05). The patients with higher Mayo score (≥10), higher hs-CRP (≥10 mg/L), and higher weight (≥70 kg) at baseline were associated with reducedremission rates. ADA and IFX treatment were generally well-tolerated and the overall safety profile matched.Conclusion: ADA and IFX were comparable in their effectiveness for inducing clinical remission and response in patients with moderate to severe UC.Both of the biologic agents were well tolerated with an approach safety profile.Keywords: Ulcerative colitis, Adalimumab, Infliximab, Clinical remission, Safety profile.