Summary

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• Remicade (infliximab) is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s Disease who have had an inadequate response to conventional therapy, reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s Disease, reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s Disease who have had an inadequate response to conventional therapy, reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate, reducing signs and symptoms of active psoriatic arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients, treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate, and reducing signs and symptoms in adult patients with active ankylosing spondylitis.
• This summary is based on the review of 94 systematic reviews/meta-analyses. ^[1-94]
• Effectiveness in Crohn’s Disease: Infliximab is effective in maintaining clinical remission in Crohn's disease, with a clinical relapse rate of 56% compared to 75% for placebo (RR 0.73). It is particularly effective in fistulizing Crohn's disease, showing a significant advantage in fistula closure (RR 2.30) at 16-24 weeks compared to placebo.
• Comparative Effectiveness in Crohn’s Disease: Infliximab, when combined with purine analogues, is superior in preventing clinical relapse compared to purine analogues alone (12% vs. 59%, RR 0.20). Infliximab's effectiveness is comparable to its biosimilars for clinical relapse rates (47% vs. 40%, RR 1.18).
• Effectiveness in Ulcerative Colitis: Infliximab effectively reduces symptoms, maintains clinical remission, and improves endoscopic outcomes in ulcerative colitis. It demonstrates superior efficacy during the induction phase compared to vedolizumab and higher efficacy in inducing clinical remission compared to treatments such as adalimumab and golimumab.
• Effectiveness in Rheumatoid Arthritis: Infliximab shows significant efficacy in reducing signs and symptoms of rheumatoid arthritis. Its effectiveness is comparable to other biologics, such as adalimumab and etanercept, in achieving clinical responses.
• Adverse Events: Infliximab is associated with common adverse events such as infections, infusion reactions, and gastrointestinal symptoms. Serious adverse events, while relatively low, include serious infections and infusion-related reactions.
• Comparative Safety: Infliximab has a higher incidence of adverse events compared to adalimumab (17.91% vs. 12.12%) and may also carry a higher risk of infections compared to other biologics, such as vedolizumab.
• Specific Safety Concerns: There is an association between infliximab and the development of paradoxical psoriasis in patients with ankylosing spondylitis. Additionally, retreatment with infliximab after a period of discontinuation may lead to high remission rates but also increases the risk of infusion-related reactions.
• Population-Specific Safety Considerations: In pediatric patients with Crohn’s disease and ulcerative colitis, infliximab is generally indicated for those aged 6 years and older. Gender-based differences have been observed, with men being less likely to achieve clinical remission during induction treatment for ulcerative colitis compared to women.
• Age and Comorbid Conditions: Infliximab is indicated for pediatric patients aged 6 years and older with moderately to severely active Crohn's disease or ulcerative colitis. Patients with a history of smoking and proctitis are at a higher risk of relapse after discontinuing infliximab, and those with rheumatoid arthritis who also use methotrexate may experience reduced efficacy.
• Gender and Biologic Exposure: Gender differences in response to infliximab have been observed, particularly in ulcerative colitis, where men are less likely to achieve clinical remission compared to women during induction treatment. Additionally, infliximab appears more effective in biologic-naïve patients for inducing clinical remission in ulcerative colitis, with comparable efficacy to other biologics in biologic-naïve patients with Crohn's disease.