Tofacitinib

(Xeljanz®)

Xeljanz®

Drug updated on 11/1/2024

Dosage FormTablet (oral; 5 mg, 10 mg); Extended-release tablet (oral; 11 mg, 22 mg); Solution (oral; 1 mg/mL)
Drug ClassJanus kinase (JAK) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers
  • Indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers
  • Indicated for the treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers
  • Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers
  • Indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers

Latest News

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Summary
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  • This summary is based on the review of 75 systematic review(s)/meta-analysis(es). [1-74]
  • Ulcerative Colitis: Tofacitinib demonstrated higher clinical remission rates compared to vedolizumab and anti-TNF (tumor necrosis factor)-alpha agents, achieving comparable steroid-free clinical remission to ustekinumab. Vedolizumab showed higher clinical remission rates than anti-TNF-alpha agents, while upadacitinib ranked best for clinical remission and mucosal healing in re-randomized patients.
  • Rheumatoid Arthritis: Tofacitinib exhibited significant improvement in ACR(American College of Rheumatology) 20/50/70 responses compared to placebo and adalimumab, ranking higher for efficacy among JAK (Janus kinase) inhibitors. Upadacitinib and baricitinib also demonstrated significant efficacy, with upadacitinib 15 mg + csDMARD (conventional synthetic disease-modifying anti-rheumatic drug) showing good efficacy in combination therapy.
  • Psoriatic Arthritis: Tofacitinib demonstrated efficacy in reducing PsARC and ACR50 responses, showing comparable effectiveness to other biological agents, including secukinumab, infliximab, and adalimumab, which ranked highest in efficacy.
  • Ankylosing Spondylitis: JAK inhibitors, including filgotinib, upadacitinib, and tofacitinib, showed significant ASAS20/40 responses, with tofacitinib ranking highest in achieving ASAS20.
  • Tofacitinib presents similar adverse event rates across therapies, with an increased risk of herpes zoster infections compared to other biologics and csDMARDs. In the context of ulcerative colitis, there are concerns regarding infections, particularly C. difficile.
  • Serious Adverse Events (SAEs) were comparable across most therapies, with some studies indicating a higher incidence of SAEs for upadacitinib 15 mg relative to other JAK inhibitors. No significant increased risk of malignancy was noted compared to csDMARDs or TNFi.
  • In Psoriatic Arthritis, JAK inhibitors showed an increased risk of infections, especially upper respiratory infections, but there was no significant increase in serious adverse events compared to placebo.
  • In Ankylosing Spondylitis, JAK inhibitors did not demonstrate significant differences in adverse events and serious adverse events compared to placebo.
  • In patients with prior biologic exposure for ulcerative colitis, upadacitinib and ustekinumab demonstrated higher remission rates, while infliximab showed higher efficacy in biologic-naive patients. In rheumatoid arthritis, JAK inhibitors like tofacitinib, upadacitinib, and baricitinib exhibited significant efficacy in patients with inadequate response to csDMARDs and comparable efficacy in biologic-experienced patients.
  • For psoriatic arthritis, tofacitinib and other biologics, including secukinumab and adalimumab, were effective in both biologic-naive and experienced patients, while in ankylosing spondylitis, tofacitinib and other JAK inhibitors showed high efficacy in TNF inhibitor-naive patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Xeljanz (tofacitinib) Prescribing Information.2024Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review2024Journal of Managed Care & Specialty Pharmacy
The efficacy and safety of different Janus kinase inhibitors as monotherapy in rheumatoid arthritis: A Bayesian network meta-analysis2024PLoS One
Comparative efficacy of five approved Janus kinase inhibitors as monotherapy and combination therapy in patients with moderate-to-severe active rheumatoid arthritis: a systematic review and network meta-analysis of randomized controlled trials2024Frontiers in Pharmacology
Effectiveness and safety of biological and target synthetic drugs treatment for psoriatic arthritis: a systematic review with network meta-analysis2024Advances in Rheumatology (London, England)
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
Comparative maintenance performance of all biologic agents and small molecules in ulcerative colitis: a network meta-analysis2024European Journal of Gastroenterology & Hepatology
Relative remission rates of Janus kinase inhibitors in comparison with adalimumab in patients with active rheumatoid arthritis: a network meta-analysis2024Zeitschrift Fur Rheumatologie
Efficacy of pharmacological interventions: a systematic review informing the 2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases2023RMD Open
Comparative of the effectiveness and safety of biological agents, small molecule drugs, and microbiome therapies in ulcerative colitis: Systematic review and network meta-analysis2023Medicine
Relative Remission and Low Disease Activity Rates of Tofacitinib, Baricitinib, Upadacitinib, and Filgotinib versus Methotrexate in Patients with Disease-Modifying Antirheumatic Drug-Naive Rheumatoid Arthritis2023Pharmacology
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
The current role of Tofacitinib in acute severe ulcerative colitis in adult patients: A systematic review2023Digestive and Liver Disease
JAK inhibitors and the risk of malignancy: a meta-analysis across disease indications2023Annals of the Rheumatic Diseases
Efficacy and safety of tofacitinib combined with methotrexate in the treatment of rheumatoid arthritis: A systematic review and meta-analysis2023Heliyon
Safety of Janus Kinase inhibitors in Patients with Alopecia Areata: A Systematic Review2023Clinical Drug Investigation
Dose Escalation Patterns of Advanced Therapies in Crohn's Disease and Ulcerative Colitis: A Systematic Literature Review2023Advances in Therapy
Tofacitinib for Acute Severe Ulcerative Colitis: A Systematic Review2023Journal of Crohn's & Colitis
Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis2023Clinicoeconomics and Outcomes Research
Efficacy and Safety of Dual Targeted Therapy for Partially or Non-responsive Inflammatory Bowel Disease: A Systematic Review of the Literature2023Digestive Diseases and Sciences
Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis2023Clinical Rheumatology
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
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis2023Annals of the Rheumatic Diseases
Are Janus kinase inhibitors safe and effective in treating the key clinical domains of psoriatic arthritis? A systematic review and meta-analysis2023International Journal of Rheumatic Diseases
Can Patients With Controlled Rheumatoid Arthritis Taper Methotrexate From Targeted Therapy and Sustain Remission? A Systematic Review and Metaanalysis2023The Journal of Rheumatology
Relative efficacy and safety of Janus kinase inhibitors for the treatment of active psoriatic arthritis: a network meta-analysis2023Zeitschrift Fur Rheumatologie
Comparative efficacy and safety of JAK inhibitors as monotherapy and in combination with methotrexate in patients with active rheumatoid arthritis: A systematic review and meta-analysis2022Frontiers in Immunology
Efficacy and safety of JAK inhibitors in the treatment of psoriasis and psoriatic arthritis: a systematic review and meta-analysis2022BMC Rheumatology
Comparative Efficacy and Safety of Janus Kinase Inhibitors and Secukinumab in Patients with Active Ankylosing Spondylitis: A Systematic Review and Meta-Analysis2022Pharmacology
Model-Based Meta-Analysis on the Efficacy of Biologics and Small Targeted Molecules for Crohn's Disease2022Frontiers in Immunology
Comparison of Adalimumab to Other Targeted Therapies in Rheumatoid Arthritis: Results from Systematic Literature Review and Meta-Analysis2022Journal of Personalized Medicine
Network meta-analysis on efficacy and safety of different Janus kinase inhibitors for ulcerative colitis2022Journal of Clinical Pharmacy and Therapeutics
Association Between Janus Kinase Inhibitors Therapy and Mental Health Outcome in Rheumatoid Arthritis: A Systematic Review and Meta-analysis2022Rheumatology and Therapy
Effectiveness and safety of tofacitinib for the treatment of ulcerative colitis: A single-arm meta-analysis of observational studies2022Digestive and Liver Disease
Real-World Effectiveness and Safety of Tofacitinib in Patients With Ulcerative Colitis: Systematic Review With Meta-Analysis2022Inflammatory Bowel Diseases
Janus kinase inhibitors for treating active ankylosing spondylitis: a meta-analysis of randomized controlled trials2022Zeitschrift Fur Rheumatologie
Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis2021Therapeutic Advances in Gastroenterology
Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: systematic review and network meta-analysis2021Gut
JAK inhibitors and psoriatic arthritis: A systematic review and meta-analysis2021Autoimmunity Reviews
Current jakinibs for the treatment of rheumatoid arthritis: a systematic review2021Inflammopharmacology
Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials2021Auto-Immunity Highlights
Comparison of the efficacy and safety of tofacitinib and mavrilimumab in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials2021International Journal of Clinical Pharmacology and Therapeutics
Comparative efficacy and safety of secukinumab, ixekizumab, and tofacitinib in patients with active psoriatic arthritis showing insufficient response to tumor necrosis factor inhibitors2021International Journal of Clinical Pharmacology and Therapeutics
Comparative efficacy and safety of Janus kinase inhibitors and biological disease-modifying antirheumatic drugs in rheumatoid arthritis: a systematic review and network meta-analysis2021Therapeutic Advances in Musculoskeletal Disease
Biologic disease modifying antirheumatic drugs and Janus kinase inhibitors in paediatric rheumatology - what we know and what we do not know from randomized controlled trials2021Pediatric Rheumatology Online Journal
Comparative Efficacy and Safety of Peficitinib Versus Tofacitinib and Baricitinib for Treatment of Rheumatoid Arthritis: A Systematic Review and Network Meta-Analysis2021Rheumatology and Therapy
Efficacy of Systemic Treatments of Nail Psoriasis: A Systemic Literature Review and Meta-Analysis2021Frontiers in Medicine
Comparative effectiveness and safety of non-tumour necrosis factor biologics and Janus kinase inhibitors in patients with active rheumatoid arthritis showing insufficient response to tumour necrosis factor inhibitors: A Bayesian network meta-analysis of randomized controlled trials2021Journal of Clinical Pharmacy and Therapeutics
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
Efficacy of Tofacitinib in the Treatment of Psoriatic Arthritis: A Systematic Review2021Advances in Therapy
Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies2021Rheumatology (Oxford, England)
Comparative study of the efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib versus methotrexate for disease-modifying antirheumatic drug-naive patients with rheumatoid arthritis2021Zeitschrift Fur Rheumatologie
Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib in active rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs2021Zeitschrift Fur Rheumatologie
Comparative of the Effectiveness and Safety of Biological Agents, Tofacitinib, and Fecal Microbiota Transplantation in Ulcerative Colitis: Systematic Review and Network Meta-Analysis2021Immunological Investigations
The effects of selected biologics and a small molecule on Health-Related Quality of Life in adult plaque psoriasis patients: A systematic review and meta-analysis2020PLoS One
Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a systematic literature research2020RMD Open
Efficacy and Safety of Tofacitinib, Baricitinib, and Upadacitinib for Rheumatoid Arthritis: A Systematic Review and Meta-Analysis2020Mayo Clinic Proceedings
Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy for active rheumatoid arthritis2020Journal of Clinical Pharmacy and Therapeutics
Comparison of the efficacy and safety of tofacitinib and peficitinib in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials2020International Journal of Rheumatic Diseases
Pharmacological treatment of psoriatic arthritis: a systematic literature research for the 2019 update of the EULAR recommendations for the management of psoriatic arthritis2020Annals of the Rheumatic Diseases
Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naive to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs: a matching-adjusted indirect comparison2020RMD Open
Comparative Efficacy of JAK Inhibitors for Moderate-To-Severe Rheumatoid Arthritis: A Network Meta-Analysis2020Advances in Therapy
Small molecule drugs in the treatment of inflammatory bowel diseases: which one, when and why? - a systematic review2020European Journal of Gastroenterology & Hepatology
A systematic review and network meta-analysis of current and investigational treatments for active ankylosing spondylitis2020Clinical Rheumatology
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis2020Annals of the Rheumatic Diseases
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
Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis2020the Cochrane Database of Systematic Reviews
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
First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis2020Clinical Gastroenterology and Hepatology
Safety of Janus Kinase Inhibitors in Patients With Inflammatory Bowel Diseases or Other Immune-mediated Diseases: A Systematic Review and Meta-Analysis2020Gastroenterology
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2020The Cochrane Database of Systematic Reviews
Comparison of the efficacy and safety of tofacitinib and filgotinib in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials2020Zeitschrift Fur Rheumatologie
Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: A systematic overview of meta-analyses2019United European Gastroenterology Journal
Effect of biologics and targeted synthetic disease-modifying anti-rheumatic drugs on fatigue in rheumatoid arthritis2019Rheumatology (Oxford, England)
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: A systematic review and network meta-analysis2019Seminars in Arthritis and Rheumatism

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