The JAK inhibitor tofacitinib for active rheumatoid arthritis: results from Phase III trials

@article{Salgado2013TheJI,
  title={The JAK inhibitor tofacitinib for active rheumatoid arthritis: results from Phase III trials},
  author={E. Salgado and J. G{\'o}mez-Reino},
  journal={International Journal of Clinical Rheumatology},
  year={2013},
  volume={8},
  pages={315-326}
}
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… Expand
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References

SHOWING 1-10 OF 57 REFERENCES
THU0136 Cardiovascular safety findings in rheumatoid arthritis patients treated with tofacitinib (CP-690,550), a novel, oral jak inhibitor
TLDR
The cardiovascular (CV) event rates and changes in blood pressure (BP) in the tofacitinib Phase 3 (P3) and long-term open-label extension (LTE) studies were evaluated to evaluate the targeted immunomodulator and disease-modifying therapy in rheumatoid arthritis. Expand
Inhibition of JAK kinases in patients with rheumatoid arthritis: scientific rationale and clinical outcomes.
TLDR
The molecular pathways through which the JAK moieties function are described along with the clinical mechanisms associated with their inhibition and plans for long-term follow-up of the described trials are describedAlong with the features of five presently ongoing Phase III trials of the CP-690,550 janus kinase (JAK) inhibitor. Expand
Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis.
TLDR
In patients with active rheumatoid arthritis, tofacitinib monotherapy was associated with reductions in signs and symptoms of rheumatism and improvement in physical function and tofacit inib treatment wasassociated with elevations in low-density lipoprotein cholesterol levels and reductions in neutrophil counts. Expand
Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial
TLDR
In this treatment-refractory population, tofacitinib with methotrexate had rapid and clinically meaningful improvements in signs and symptoms of rheumatoid arthritis and physical function over 6 months with manageable safety. Expand
Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs.
TLDR
Tofacitinib monotherapy at a dose of ≥3 mg twice a day was efficacious in the treatment of patients with active RA over 24 weeks and demonstrated a manageable safety profile. Expand
AB0363 Coadministration of asp015k, a novel janus kinase inhibitor, with methotrexate demonstrates tolerability and lack of pharmacokinetic interactions in patients with rheumatoid arthritis
TLDR
Coadministration of ASP015K and MTX was well tolerated in this short-term study, exhibiting no clinically significant effect on the PK profile of either drug. Expand
THU0131 Tofacitinib (CP-690,550), an oral janus kinase inhibitor: Analysis of malignancies across the rheumatoid arthritis clinical programme
TLDR
The malignancies that occurred in the tofacitinib RA programme are consistent with the type and distribution of malignancy expected for patients with moderate to severe RA, and with published estimates in RA patients treated with biologic and non-biologic DMARDs. Expand
Tofacitinib or adalimumab versus placebo in rheumatoid arthritis.
TLDR
In patients with rheumatoid arthritis receiving background methotrexate, tofacitinib was significantly superior to placebo and was numerically similar to adalimumab in efficacy. Expand
A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone.
TLDR
In patients with active RA in whom the response to MTX has been inadequate, the addition of tofacitinib at a dosage ≥3 mg twice daily showed sustained efficacy and a manageable safety profile over 24 weeks. Expand
THU0140 Tofacitinib (CP-690,550), an oral janus kinase inhibitor: Analysis of gastrointestinal adverse events across the rheumatoid arthritis clinical programme
TLDR
The incidence of gastrointestinal (GI) adverse events (AEs) that occurred in the tofacitinib RA programme up to 29 March 2011 was described and report. Expand
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