Infliximab

(Remicade®)

Remicade®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 100 mg)
Drug ClassTumor necrosis factor (TNF) blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for Crohns Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy, and reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease
  • Indicated for pediatric Crohns 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 disease who have had an inadequate response to conventional therapy
  • Indicated for ulcerative colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
  • Indicated for pediatric ulcerative colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy
  • Indicated for rheumatoid arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active disease
  • Indicated for psoriatic arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients
  • Indicated for plaque psoriasis: 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
  • Indicated for ankylosing spondylitis: reducing signs and symptoms in adult patients with active disease.

Latest News

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Summary
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  • This summary is based on the review of 113 systematic review(s)/meta-analysis(es). [1-113]
  • Induction of Clinical Remission: Infliximab (IFX) was highly effective for inducing remission in both Crohn’s disease (CD) and ulcerative colitis (UC), particularly among biologic-naive patients, outperforming both vedolizumab (VDZ) and adalimumab in certain comparisons. Upadacitinib and tofacitinib also showed high efficacy in UC, with upadacitinib ranking highest for induction in moderate-to-severe cases.
  • Maintenance of Clinical Remission: During maintenance, infliximab combined with azathioprine demonstrated superior efficacy in sustaining remission across CD and UC. Vedolizumab was ranked highest for maintaining remission in UC, and ustekinumab showed effective maintenance in both CD and UC populations.
  • Endoscopic Improvement: Infliximab achieved significant endoscopic improvement during maintenance therapy, particularly in UC, while vedolizumab ranked highly for this outcome in UC. Both ustekinumab and tofacitinib were effective for endoscopic improvement in UC patients.
  • Comparative Efficacy Among Biologics: Infliximab showed superior induction efficacy over vedolizumab but comparable maintenance effectiveness. Tofacitinib and upadacitinib provided robust efficacy in UC, with upadacitinib showing the highest induction effect. Adalimumab was effective but generally showed lower efficacy in comparison to IFX and VDZ, especially in biologic-experienced patients.
  • Adverse Events (AEs): Infliximab and vedolizumab demonstrated similar rates of overall adverse events, while tofacitinib was associated with higher rates of adverse events, particularly infections, compared to placebo. Ustekinumab had a favorable safety profile similar to placebo, and adalimumab showed a comparable safety profile to other tumor necrosis factor (TNF) inhibitors.
  • Serious Adverse Events (SAEs): Infliximab and ustekinumab showed similar rates of serious adverse events to placebo. Vedolizumab presented a lower risk of serious infections compared to other biologics, whereas tofacitinib was linked to an increased risk of serious infections, particularly at higher doses.
  • Infections: Infliximab and adalimumab had higher risks of infections relative to placebo, with comparable infection rates between the two. Vedolizumab demonstrated a lower infection risk compared to TNF inhibitors, while tofacitinib had a notably higher risk of both general and serious infections.
  • Comparative Safety: Vedolizumab had a lower risk of serious infections compared to infliximab, and ustekinumab generally showed a more favorable safety profile with fewer serious adverse events in comparison to TNF inhibitors.
  • Age and Disease Duration: Older patients presented a higher baseline risk of serious adverse events, yet there was no additional risk associated with anti-TNF therapy compared to younger patients. Conversely, biologic-naive patients and those with shorter disease duration exhibited better clinical outcomes and response rates, indicating a need for tailored treatment strategies based on age and disease characteristics.
  • Gender and Smoking Status: Men experienced lower rates of clinical remission and response compared to women during induction therapy with TNF inhibitors. Additionally, current smokers demonstrated reduced efficacy with TNF inhibitors, which may significantly influence treatment outcomes.

Product Monograph / Prescribing Information

Document TitleYearSource
Remicade (infliximab) Prescribing Information.2021Janssen Biotech, Inc., Titusville, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis2024Annals Of The Rheumatic Diseases
Comparisons of infection events associated with tumor necrosis factor inhibitors in patients with inflammatory arthritis: A systematic review and network meta-analysis2024Frontiers In Pharmacology
Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease2024Expert Opinion On Biological Therapy
Effectiveness and safety of biological and target synthetic drugs treatment for psoriatic arthritis: a systematic review with network meta-analysis2024Advances In Rheumatology (London, England)
Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn's disease and ulcerative colitis included in randomised controlled trials2024Bmc Gastroenterology
Evaluating the Efficacy of Infliximab in Inflammatory Bowel Disease: A Systematic Review of the Literature2024Cureus
The Association between Genetics and Response to Treatment with Biologics in Patients with Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, and Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis2024International Journal Of Molecular Sciences
Intravenous Versus Subcutaneous Infliximab in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis2024Journal Of Crohn'S & Colitis
Comparative Efficacy of Subcutaneous and Intravenous Infliximab and Vedolizumab for Maintenance Treatment of TNF-naive Adult Patients with Inflammatory Bowel Disease: A Systematic Literature Review and Network Meta-analysis2024Digestive Diseases And Sciences
Comparative maintenance performance of all biologic agents and small molecules in ulcerative colitis: a network meta-analysis2024European Journal Of Gastroenterology & Hepatology
Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis2024American Journal Of Clinical Dermatology
Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis2023Bmc Gastroenterology
Efficacy and safety of TNF inhibitors in the treatment of juvenile idiopathic arthritis: a systematic literature review2023Pediatric Rheumatology Online Journal
Assessing the Relationship between the Gut Microbiota and Inflammatory Bowel Disease Therapeutics: A Systematic Review2023Pathogens (Basel, Switzerland)
The comparative efficacy and safety of biologics and small molecules for treating patients with ulcerative colitis in Portugal: a systematic literature review and network meta-analysis2023European Review For Medical And Pharmacological Sciences
Systematic Review and Meta-analysis: Loss of Response and Need for Dose Escalation of Infliximab and Adalimumab in Ulcerative Colitis2023Inflammatory Bowel Diseases
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2023The Cochrane Database Of Systematic Reviews
Dose Escalation Patterns of Advanced Therapies in Crohn's Disease and Ulcerative Colitis: A Systematic Literature Review2023Advances In Therapy
Impact of switching between reference biologics and biosimilars of tumour necrosis factor inhibitors for rheumatoid arthritis: a systematic review and network meta-analysis2023Scientific Reports
Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis2023Jama Network Open
Cost-Effectiveness Analysis of Tofacitinib Compared with Biologics in Biologic-Naive Patients with Moderate-to-Severe Ulcerative Colitis in Japan2023Pharmacoeconomics
Infliximab Pricing in International Economic Evaluations in Inflammatory Bowel Disease to Inform Biologic and Biosimilar Access Policies: A Systematic Review2023Mdm Policy & Practice
Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis2023Clinicoeconomics And Outcomes Research : Ceor
Cost-effectiveness analysis of bimekizumab for the treatment of active psoriatic arthritis in Sweden2023Journal Of Medical Economics
Cost-Utility Analysis of Biologic Disease-Modifying Antirheumatic Drugs for Patients With Psoriatic Arthritis in Thailand2023Value In Health Regional Issues
Use of biologics for the management of Crohn's disease: IG-IBD technical review based on the GRADE methodology2023Digestive And Liver Disease : Official Journal Of The Italian Society Of
Cost-effectiveness Analysis of Subcutaneous Infliximab for Inflammatory Bowel Diseases in Sequential Biologic Treatment2023Inflammatory Bowel Diseases
Gender-Based Differences in Response to Tumor Necrosis Factor Inhibitor Therapies for Ulcerative Colitis: Individual Participant Data Meta-Analyses of Clinical Trials2023Inflammatory Bowel Diseases
Infliximab for medical induction of remission in Crohn's disease2023The Cochrane Database Of Systematic Reviews
Network meta-analysis: efficacy and safety of treatments for fistulising Crohn's disease2023European Journal Of Gastroenterology & Hepatology
Comparative efficacy of advanced treatments in biologic-naive or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis2023International Journal Of Clinical Pharmacy
Efficacy of biological therapies and small molecules in induction and maintenance of remission in luminal Crohn's disease: systematic review and network meta-analysis2023Gut
Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis2022Bmc Gastroenterology
Cost-Effectiveness of Therapeutic Drug Monitoring of Anti-TNF Therapy in Inflammatory Bowel Disease: A Systematic Review2022Pharmaceutics
Network meta-analysis and cost-effectiveness analysis of infliximab, cyclosporine and tacrolimus for ulcerative colitis2022Medicine
Systematic review and meta-analysis: evaluating response to empiric anti-TNF dose intensification for secondary loss of response in Crohn's disease2022Therapeutic Advances In Gastroenterology
Model-Based Meta-Analysis on the Efficacy of Biologics and Small Targeted Molecules for Crohn's Disease2022Frontiers In Immunology
The Effect of Pregnancy and Inflammatory Bowel Disease on the Pharmacokinetics of Drugs Related to Inflammatory Bowel Disease-A Systematic Literature Review2022Pharmaceutics
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2022The Cochrane Database Of Systematic Reviews
Biologic Disease-Modifying Antirheumatic Drugs for Preventing Radiographic Progression in Psoriatic Arthritis: A Systematic Review and Network Meta-Analysis2022Pharmaceutics
Number Needed to Treat Network Meta-Analysis to Compare Biologic Drugs for Moderate-to-Severe Psoriasis2022Advances In Therapy
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year2022The Journal Of Dermatological Treatment
Comparative efficacy of secukinumab against adalimumab and infliximab in patients with moderate-to-severe plaque psoriasis2022Chinese Medical Journal
An economic evaluation of risankizumab versus other biologic treatments of moderate to severe plaque psoriasis in Japan2022The Journal Of Dermatological Treatment
Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis2022The Journal Of Dermatological Treatment
The Risk of Adverse Effects of TNF-alpha Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis2022Frontiers In Immunology
Biologics Can Significantly Improve Dermatology Life Quality Index (DLQI) in Psoriatic Patients: A Systematic Review2022Psoriasis (Auckland, N.Z.)
Prediction of Relapse After Anti-Tumor Necrosis Factor Cessation in Crohn's Disease: Individual Participant Data Meta-analysis of 1317 Patients From 14 Studies2022Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal
Risk Prediction and Comparative Efficacy of Anti-TNF vs Thiopurines, for Preventing Postoperative Recurrence in Crohn's Disease: A Pooled Analysis of 6 Trials2022Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal
Comparative safety of infliximab and adalimumab on pregnancy outcomes of women with inflammatory bowel diseases: a systematic review & meta-analysis2022Bmc Pregnancy And Childbirth
Efficacy of Biologic Drugs in Short-Duration Versus Long-Duration Inflammatory Bowel Disease: A Systematic Review and an Individual-Patient Data Meta-Analysis of Randomized Controlled Trials2022Gastroenterology
Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis2022The Lancet. Gastroenterology & Hepatology
Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes2022Rmd Open
The response to TNF blockers depending on their comparator in rheumatoid arthritis clinical trials: the lessebo effect, a meta-analysis2022Rheumatology (Oxford, England)
The influence of biologics on the microbiome in immune-mediated inflammatory diseases: A systematic review2021Biomedicine & Pharmacotherapy = Biomedecine & Pharmacotherapie
Predictive value of blood concentration of biologics on endoscopic inactivity in inflammatory bowel disease: A systematic review2021World Journal Of Gastroenterology
A Systematic Review on Cost-effectiveness Analyses of Therapeutic Drug Monitoring for Patients with Inflammatory Bowel Disease: From Immunosuppressive to Anti-TNF Therapy2021Inflammatory Bowel Diseases
Systematic Review and Network Meta-Analysis: Comparative Efficacy and Safety of Biosimilars, Biologics and JAK1 Inhibitors for Active Crohn Disease2021Frontiers In Pharmacology
Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis2021Expert Review Of Clinical Immunology
Dose Adjustment of Biologic Treatments for Moderate-to-Severe Plaque Psoriasis in the Real World: A Systematic Review2021Dermatology And Therapy
Efficacy and tolerability of infliximab retreatment in patients with inflammatory bowel disease: a systematic review and meta-analysis2021Therapeutic Advances In Chronic Disease
Systematic review: efficacy of escalated maintenance anti-tumour necrosis factor therapy in Crohn's disease2021Alimentary Pharmacology & Therapeutics
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2021The Cochrane Database Of Systematic Reviews
Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis2021The Lancet. Gastroenterology & Hepatology
Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis2021Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals And Gene Therapy
Cost-Effectiveness Analysis of Vedolizumab Compared With Infliximab in Anti-TNF-alpha-Naive Patients With Moderate-to-Severe Ulcerative Colitis in China2021Frontiers In Public Health
Comparative of the Effectiveness and Safety of Biological Agents, Tofacitinib, and Fecal Microbiota Transplantation in Ulcerative Colitis: Systematic Review and Network Meta-Analysis2021Immunological Investigations
Anti-TNF and immunosuppressive combination therapy is preferential to inducing clinical remission in patients with active inflammatory bowel disease: A systemic review and meta-analysis2021Journal Of Digestive Diseases
Risk of herpes zoster associated with biological therapies for psoriasis and psoriatic arthritis: A systematic review and meta-analysis2021Medicine
Impact of using concomitant conventional DMARDs on adherence to biologic DMARD treatment in rheumatoid arthritis: Multi-centre, population-based cohort study2021Seminars In Arthritis And Rheumatism
P014 Postoperative Recurrence in Crohn's Disease Patients Treated with Adalimumab versus Infliximab: A Systematic Review and Meta-Analysis2021The American Journal Of Gastroenterology
Network meta-analysis of infliximab biosimilars for the treatment of rheumatoid arthritis2021American Journal Of Health-System Pharmacy : Ajhp : Official Journal Of The
CORRELATION BETWEEN TROUGH LEVELS OF INFLIXIMAB AND POSTOPERATIVE ENDOSCOPIC RECURRENCE IN CROHN'S DISEASE PATIENTS SUBMITTED TO ILEOCOLONIC RESECTIONS: A SYSTEMATIC REVIEW2021Arquivos De Gastroenterologia
Systematic Review and Recommendations to Combine Newer Therapies With Conventional Therapy in Psoriatic Disease2021Frontiers In Medicine
Review of treatments for generalized pustular psoriasis2021The Journal Of Dermatological Treatment
The efficacy and safety of infliximab and calcineurin inhibitors in steroid-refractory UC patients: A meta-analysis2021Saudi Journal Of Gastroenterology : Official Journal Of The Saudi
Smoking May Reduce the Effectiveness of Anti-TNF Therapies to Induce Clinical Response and Remission in Crohn's Disease: A Systematic Review and Meta-analysis2021Journal Of Crohn'S & Colitis
Ciclosporin or Infliximab as Rescue Therapy in Acute Glucorticosteroid-Refractory Ulcerative Colitis: Systematic Review and Network Meta-Analysis2021Journal Of Crohn'S & Colitis
Anti -TNFalpha agents in preventing the postoperative recurrence of Crohn's disease: Do they still play a role in the biological era?2021Expert Opinion On Biological Therapy
Inflammatory Bowel Disease and Neutrophil-Lymphocyte Ratio: A Systematic Scoping Review2021Journal Of Clinical Medicine
Will the Inducing and Maintaining Remission of Non-biological Agents and Biological Agents Differ for Crohn's Disease? The Evidence From the Network Meta-Analysis2021Frontiers In Medicine
Effect of Concomitant Therapy With Steroids and Tumor Necrosis Factor Antagonists for Induction of Remission in Patients With Crohn's Disease: A Systematic Review and Pooled Meta-analysis2021Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal
Safety and Efficacy of Tumor Necrosis Factor Antagonists in Older Patients With Ulcerative Colitis: Patient-Level Pooled Analysis of Data From Randomized Trials2021Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal
Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: systematic review and network meta-analysis2021Gut
Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: a network meta-analysis2021Expert Review Of Gastroenterology & Hepatology
Long-Term Efficacy of Anti-Tumor Necrosis Factor Agents in Pediatric Luminal Crohn's Disease: A Systematic Review of Real-World Evidence Studies2020Pediatric Gastroenterology, Hepatology & Nutrition
Efficacy of ustekinumab vs. advanced therapies for the treatment of moderately to severely active ulcerative colitis: a systematic review and network meta-analysis2020Current Medical Research And Opinion
Review article: determination of the therapeutic range for therapeutic drug monitoring of adalimumab and infliximab in patients with inflammatory bowel disease2020Alimentary Pharmacology & Therapeutics
Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis2020Rmd Open
Fourteen small molecule and biological agents for psoriatic arthritis: A network meta-analysis of randomized controlled trials2020Medicine
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2020The Cochrane Database Of Systematic Reviews
Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis2020Annals Of The Rheumatic Diseases
Efficacy of anti-TNFalpha drugs in patients with stricturing Crohn's disease2020Expert Review Of Gastroenterology & Hepatology
Management of Residual Psoriasis in Patients on Biologic Treatment2020Journal Of Drugs In Dermatology : Jdd
Patient characteristics as effect modifiers for psoriasis biologic treatment response: an assessment using network meta-analysis subgroups2020Systematic Reviews
Biological therapy for pustular psoriasis: a systematic review2020International Journal Of Dermatology
Biological therapy in pediatric age2020Pharmacological Research
Systematic Review and External Validation of Prediction Models Based on Symptoms and Biomarkers for Identifying Endoscopic Activity in Crohn's Disease2020Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal
Comparison of cumulative clinical benefits of biologics for the treatment of psoriasis over 16 weeks: Results from a network meta-analysis2020Journal Of The American Academy Of Dermatology
Systematic review: medical therapy for fibrostenosing Crohn's disease2020Alimentary Pharmacology & Therapeutics
First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis2020Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal
Efficacy of infliximab, cyclosporine and tacrolimus on ulcerative colitis: A meta-analysis2020Medicine
Efficacy of Tumour Necrosis Factor-alpha therapy in paediatric Crohn's disease patients with perianal lesions: a systematic review2020Expert Opinion On Biological Therapy
Efficacy and safety of methotrexate in the management of inflammatory bowel disease: A systematic review and meta-analysis of randomized, controlled trials2020Eclinicalmedicine
Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease2020Digestive Diseases And Sciences
Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Infliximab in Pediatric Inflammatory Bowel Disease: A Systematic Review and Revised Dosing Considerations2020Journal Of Pediatric Gastroenterology And Nutrition
A systematic review and network meta-analysis of current and investigational treatments for active ankylosing spondylitis2020Clinical Rheumatology
Number needed to treat and cost per remitter for biologic treatments of Crohn's disease in Japan2020Journal Of Medical Economics
Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis2019Frontiers In Medicine
Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: A systematic overview of meta-analyses2019United European Gastroenterology Journal
Dose escalation and switching of biologics in ulcerative colitis: a systematic literature review in real-world evidence2019Current Medical Research And Opinion
Anti-IL-12/23p40 antibodies for maintenance of remission in Crohn's disease2019The Cochrane Database Of Systematic Reviews
Decision-Analytic Modeling for Time-Effectiveness of the Sequence of Induction Treatments for Moderate to Severe Plaque Psoriasis2019Jama Dermatology

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