The JAK inhibitor tofacitinib for active rheumatoid arthritis: results from Phase III trials. (June 2013)

• Record Type: Journal Article
• Authors: Salgado, Eva; Gómez-Reino, Juan J
• Is Part Of: International journal of clinical rheumatology. Volume 8:Number 3(2013)
• Page Start: 315
• Page End: 326
• Publication Date: 2013-06
• Subjects: CP-690, 55 -- JAK -- ORAL trials -- protein kinase inhibitor -- rheumatoid arthritis -- tofacitinib; Rheumatology -- Periodicals; 616.723005
• DOI: 10.2217/ijr.13.26
• Languages: English
• ISSNs: 1758-4272

Abstract

Tofacitinib is a Janus kinase inhibitor that modulates the transcription of cytokine genes involved in immune regulation and hematopoiesis. This clinical trial report focuses on ORAL Solo, ORAL Standard, ORAL Step and ORAL Scan Phase III trials of the tofacitinib ORAL program. ORAL Solo shows an early and sustained clinical efficacy with tofacitinib monotherapy in rheumatoid arthritis (RA) patients with inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs. ORAL Standard demonstrates clinical response to tofacitinib plus methotrexate (MTX) in RA patients who had MTX-inadequate response. ORAL Step indicates rapid clinical response to tofacitinib plus MTX in TNF antagonist-inadequate response RA patients. ORAL Scan demonstrates that tofacitinib inhibits radiographic progression and improves clinical parameters in patients treated with tofacitinib and MTX. Upper respiratory tract infection, headache, diarrhea and nasopharyngitis were common adverse events. Tofacitinib is a new small molecule for the treatment of RA; long-term safety data and comparisons with other disease-modifying antirheumatic drugs will determine the role of tofacitinib in the treatment of RA.