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Tofacitinib in the treatment of active rheumatoid arthritis in adults
1Department of Medicine, University of Texas Southwestern Medical Center, 8144 Walnut Hill Lane, Dallas, Texas 75231, USA.
Abstract:
Tofacitinib, a pan Janus kinase inhibitor, has been investigated as monotherapy in patients naive to methotrexate and in methotrexate incomplete responders and in combination with disease-modifying antirheumatic drugs in antirheumatic drug incomplete responders and TNF inhibitor failures in the Phase II and III programs. The clinical trial program demonstrated efficacy and a reasonable safety profile in these disease populations that has led to the approval of tofacitinib 5 mg twice daily orally in many countries. The pharmacology, chemistry, pharmacokinetics, pharmacodynamics, efficacy and safety in the Phase II and III clinical trials, safety in the long-term extension studies and postmarketing safety reports are the focus of this review.
Insights
Tofacitinib, a Janus kinase inhibitor, showed efficacy and a good safety profile in clinical trials for rheumatoid arthritis. This review covers its pharmacology, pharmacokinetics, efficacy, and safety data.
Area of Science:
- Rheumatology
- Pharmacology
- Clinical Trials
Background:
- Tofacitinib is a pan Janus kinase inhibitor.
- Investigated in rheumatoid arthritis patients naive to methotrexate, methotrexate incomplete responders, and in combination therapies.
Purpose of the Study:
- To review the pharmacology, chemistry, pharmacokinetics, pharmacodynamics, efficacy, and safety of tofacitinib.
- To consolidate data from Phase II/III trials, long-term extension studies, and postmarketing reports.
Main Methods:
- Review of data from Phase II and III clinical trials.
- Inclusion of data from long-term extension studies.
- Analysis of postmarketing safety reports.
Main Results:
- Tofacitinib demonstrated efficacy in various patient populations.
- A reasonable safety profile was observed across studies.
- Led to regulatory approval in many countries for oral tofacitinib 5 mg twice daily.
Conclusions:
- Tofacitinib is an effective treatment option for rheumatoid arthritis.
- The drug exhibits a manageable safety profile based on comprehensive trial and postmarketing data.
- Supports the use of tofacitinib in approved patient groups.