Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial

@article{Bachelez2015TofacitinibVE,
  title={Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial},
  author={Herv{\'e} Bachelez and Peter van de Kerkhof and Robert Strohal and Alexey A. Kubanov and Fernando Valenzuela and Joo-Heung Lee and Vladimir V Yakusevich and Sergio Chimenti and Jocelyne Papacharalambous and James Proulx and Pankaj Gupta and Huaming Tan and Margaret Tawadrous and Hernan Valdez and Robert Wolk},
  journal={The Lancet},
  year={2015},
  volume={386},
  pages={552-561}
}
View on Elsevier
doi.org
325 Citations
Highly Influential Citations
9
Background Citations
70
Methods Citations
10
Results Citations
14

Figures and Tables from this paper

325 Citations

Oral tofacitinib efficacy, safety and tolerability in Japanese patients with moderate to severe plaque psoriasis and psoriatic arthritis: A randomized, double‐blind, phase 3 study

Tofacitinib (both doses) demonstrated efficacy in patients with moderate to severe plaque psoriasis and/or psoriatic arthritis through 52 weeks; safety findings were generally consistent with prior studies.

Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: Subgroup analyses from a randomized, placebo‐controlled phase 3 trial

Results were generally consistent with global analysis, suggesting sustained efficacy and a manageable safety profile, with increased herpes zoster incidence, of tofacitinib in Japanese patients with psoriasis.

The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study.

Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial

In adults with mild to moderate plaque psoriasis, 2 % tofacitinib ointment QD and BID showed greater efficacy than vehicle at Week 8, but not Week 12, with an acceptable safety and local tolerability profile.

Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study.

Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52‐week, randomized, controlled phase 3 studies in patients with moderate‐to‐severe plaque psoriasis

Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors

In this trial involving patients with active psoriatic arthritis who had had an inadequate response to TNF inhibitors, tofacitinib was more effective than placebo over 3 months in reducing disease activity.

Tofacitinib in Pediatric Psoriasis: An Open-Label Trial to Study Its Safety and Efficacy in Children

The treatment with tofacitinib was safe and well tolerated, and led to significant improvement of their disease and quality of life as reflected in CDLQI scores, however, the results need to be validated in larger multicenter trials.

Oral tofacitinib for the treatment of adults with moderate to severe chronic plaque psoriasis

An effective oral treatment without the organ toxicities of methotrexate and cyclosporine, tofacitinib is a promising alternative to biologics in the treatment of moderate-to-severe psoriasis.

Long‐term safety data for tofacitinib, an oral Janus kinase inhibitor, for the treatment for psoriasis

The safety data for tofacitinib from this open-label extension study are consistent with those previously reported and small increases in mean low-density and high-density lipoprotein cholesterol levels appeared stable during the study.
...

References

SHOWING 1-10 OF 34 REFERENCES

Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2)

Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis.

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.

Tofacitinib or adalimumab versus placebo in rheumatoid arthritis.

In patients with rheumatoid arthritis receiving background methotrexate, tofacitinib was significantly superior to placebo and was numerically similar to adalimumab in efficacy.

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

Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1)

Application of the Itch Severity Score in patients with moderate-to-severe plaque psoriasis: Clinically important difference and responder analyses*

The CID and CIR analyses play vital roles in the interpretation of the treatment effects measured by the Itch Severity Score, a 0–10 numeric rating scale used to assess pruritus due to psoriasis in a Phase 2 b trial of tofacitinib.

Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study.

Data from this 12-month interim analysis demonstrate that tofacitinib inhibits progression of structural damage and improves disease activity in patients with RA who are receiving MTX.

Dose Response and Pharmacokinetics of Tofacitinib (CP-690,550), an Oral Janus Kinase Inhibitor, in the Treatment of Chronic Plaque Psoriasis

Bayesian estimation was applied with prior information derived from the literature: nonclinical and clinical data in psoriasis, as well as other indications, to characterize the dose–response profile of tofacitinib using data from a placebo‐controlled dose‐ranging study.

Traditional therapies in the management of moderate to severe chronic plaque psoriasis: an assessment of the benefits and risks

The benefits and risks of traditional, nonbiological therapies for moderate to severe chronic plaque psoriasis must be weighed carefully for each patient, and treatment individualized accordingly.

Current status and new developments in the treatment of psoriasis and psoriatic arthritis with biological agents

  • W. Weger
  • Medicine, Biology
    British journal of pharmacology
  • 2010
A brief overview of the currently approved biological agents in the European Union and of some newer agents, such as briakinumab, certolizumab and golimumab are provided.