Drug updated on 4/15/2024
| 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.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Xeljanz (tofacitinib) Prescribing Information. | 2022 | Pfizer Inc., New York, NY |