Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 5 mg, 10 mg); Extended-release tablet (oral; 11 mg, 22 mg); Solution (oral; 1 mg/mL) |
Drug Class | Janus 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
Summary
- Xeljanz (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. It is also used for treating moderately to severely active ulcerative colitis in adults with a similar treatment history. Additionally, it is indicated for treating active polyarticular course juvenile idiopathic arthritis in patients aged 2 years and older who have not responded adequately to one or more TNF blockers.
- This summary is based on the review of 32 systematic review(s)/meta-analysis(es). [1-32]
- Ulcerative Colitis (UC): Upadacitinib demonstrated superior efficacy in clinical remission and mucosal healing compared to tofacitinib, particularly in the induction phase, with remission rates of 34.7% at week 8, 47% at weeks 12-16, and 38.3% at month 6.
- Psoriatic Arthritis (PsA): Tofacitinib showed superior efficacy compared to placebo across key clinical domains, including ACR20, ACR50, ACR70, PASI75, enthesitis resolution, and dactylitis resolution.
- Comparative Efficacy: Tofacitinib's effectiveness in RA was comparable to baricitinib and upadacitinib, while upadacitinib showed higher efficacy in UC compared to tofacitinib. In Psoriasis and PsA, tofacitinib demonstrated superior efficacy in PASI75 and ACR20 compared to other JAK inhibitors.
- Rheumatoid Arthritis (RA): Tofacitinib-treated patients exhibited a higher incidence of herpes zoster (2.2-7.1/100 patient-years) compared to other JAK inhibitors, with no significant difference in overall cancer risk compared to placebo or biological drugs.
- Herpes Zoster and Infection Risks: Tofacitinib-treated patients had a higher incidence of herpes zoster, especially at higher doses or with concomitant glucocorticoids. There was also an increased risk of infections, including herpes zoster and upper respiratory tract infections, particularly at higher doses.
- Cancer and Cardiovascular Risks: There was no significant difference in overall cancer risk compared to placebo or biological drugs, but a slightly higher risk was observed compared to TNF inhibitors. Tofacitinib did not show a significant increase in major adverse cardiovascular events (MACE) risk compared to placebo, though all-cause mortality was higher compared to adalimumab.
- Venous Thromboembolism (VTE): There was a potential increase in VTE risk, particularly at higher doses of tofacitinib.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Xeljanz (tofacitinib) Prescribing Information. | 2022 | Pfizer Inc., New York, NY |