Tofacitinib

(Xeljanz®)

Xeljanz®

Drug updated on 4/15/2024

Dosage FormTablet (oral; 5 mg, 10 mg); Extended-release tablet (oral; 11 mg, 22 mg); Solution (oral; 1 mg/mL)
Drug ClassJanus kinase 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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  • Tofacitinib (Xeljanz) is approved for the management of adult patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis who have not responded adequately or are intolerant to one or more TNF blockers. It is also effective in treating active polyarticular course juvenile idiopathic arthritis in patients aged 2 years and above.
  • The data was synthesized from a total of 32 systematic reviews/meta-analyses focusing on Tofacitinib (Xeljanz).
  • Relative to other JAK inhibitors and TNF blockers, Tofacitinib has shown a higher incidence of herpes zoster, particularly at elevated doses and when used in combination with glucocorticoids.
  • Regarding the risk of cancer, Tofacitinib does not significantly heighten the overall cancer risk in comparison to placebo or biological drugs, though there is a slightly increased risk for non-melanoma skin cancer versus anti-TNF agents.
  • Cardiovascular safety assessments suggest that JAK inhibitors, including Tofacitinib, may not elevate the risk of major adverse cardiovascular events when compared with adalimumab, yet there could be an associated greater all-cause mortality rate than with TNF inhibitors.
  • There is a potential, though statistically insignificant, increase in venous thromboembolism risks associated with the use of JAK inhibitors like Tofacitinib, particularly at higher doses, according to available meta-analysis data.
  • Higher doses of this medication are linked to increased infection risks, including serious infections and upper respiratory tract infections.
  • The effectiveness varies among different indications, being dose-dependent; higher doses generally demonstrate superior outcomes, but this is accompanied by increased adverse effects.

Product Monograph / Prescribing Information

Document TitleYearSource
Xeljanz (tofacitinib) Prescribing Information.2022Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Herpes zoster in patients with inflammatory arthritides or ulcerative colitis treated with tofacitinib, baricitinib or upadacitinib: a systematic review of clinical trials and real-world studies.2023Rheumatology International
Cancer risk in patients treated with the jak inhibitor tofacitinib: systematic review and meta-analysis.2023Cancers
Tofacitinib for acute severe ulcerative colitis: a systematic review.2023Journal of Chron’s and Colitis
Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis.2023Clinical Rheumatology
Efficacy and safety of dual targeted therapy for partially or non-responsive inflammatory bowel disease: a systematic review of the literature.2023Digestive Diseases and Sciences
The current role of tofacitinib in acute severe ulcerative colitis in adult patients: a systematic review. 2023Digestive and Liver Disease
Comparative of the effectiveness and safety of biological agents, small molecule drugs, and microbiome therapies in ulcerative colitis: systematic review and network meta-analysis. 2023Medicine
Risk of herpes zoster associated with JAK inhibitors in immune-mediated inflammatory diseases: a systematic review and network meta-analysis. 2023Frontiers in Pharmacology
Cardiovascular safety of Janus kinase inhibitors in patients with rheumatoid arthritis: systematic review and network meta-analysis. 2023Frontiers in Pharmacology
Safety of biologic and small molecule therapy for inflammatory bowel disease among solid organ transplant recipients: systematic review and meta-analysis.2023Inflammatory Bowel Diseases
Relative remission and low disease activity rates of tofacitinib, baricitinib, upadacitinib, and filgotinib versus methotrexate in patients with disease-modifying antirheumatic drug-naive rheumatoid arthritis. 2023Pharmacology
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-analysis. 2023European Reviews for Medical and Pharmacological Sciences
Risk of venous thromboembolism with Janus kinase inhibitors in inflammatory immune diseases: a systematic review and meta-analysis. 2023Frontiers in Pharmacology
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-analysis.2022Frontiers in Immunology
Association between Janus kinase inhibitors therapy and mental health outcome in rheumatoid arthritis: a systematic review and meta-analysis.2022Rheumatology and Therapy
Real-world effectiveness and safety of tofacitinib in patients with ulcerative colitis: systematic review with meta-analysis. 2022Inflammatory Bowel Diseases
Are Janus kinase inhibitors safe and effective in treating the key clinical domains of psoriatic arthritis? A systematic review and meta-analysis.2022International Journal of Rheumatic Diseases
Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis.2022International Journal of Clinical Pharmacy
Comparative efficacy and safety of janus kinase inhibitors and biological disease-modifying antirheumatic drugs in rheumatoid arthritis: a systematic review and network meta-analysis.2021Therapeutic Advances in Musculoskeletal Disease
Comparative efficacy and safety of peficitinib versus tofacitinib and baricitinib for treatment of rheumatoid arthritis: a systematic review and network meta-analysis.2021Rheumatology and Therapy
Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis. 2021Therapeutic Advances in Gastroenterology
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.2021The Cochrane Database of Systematic Reviews
Current jakinibs for the treatment of rheumatoid arthritis: a systematic review. 2021Inflammopharmacology
Efficacy and safety of tofacitinib, baricitinib, and upadacitinib for rheumatoid arthritis: a systematic review and meta-analysis.2020Mayo Clinic
Risk of venous thromboembolism associated with tofacitinib and baricitinib: a systematic review and indirect meta‐analysis. 2020Pharmacotherapy
Efficacy of tofacitinib in the treatment of psoriatic arthritis: a systematic review. 2020Advances in Therapy
Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis.2020The Cochrane Database of Systematic Reviews
Efficacy and safety of tofacitinib for the treatment of chronic plaque psoriasis: a systematic review and meta-analysis.2019Journal of International Medical Research
Effect of tofacitinib on cardiovascular events and all-cause mortality in patients with immune-mediated inflammatory diseases: a systematic review and meta-analysis of randomized controlled trials.2019Therapeutic Advances in Musculoskeletal Disease
Impact of Janus kinase inhibitors on risk of cardiovascular events in patients with rheumatoid arthritis: systematic review and meta-analysis of randomised controlled trials.2019Annals of the Rheumatic Diseases
Time until onset of action when treating psoriatic arthritis: meta-analysis and novel approach of generating confidence intervals. 2019Rheumatology International
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis.2019EULAR

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