Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis

Abstract

Background: The ability to predict response to psoriasis treatments has important implications. Tofacitinib is an oral JAK inhibitor being investigated for psoriasis.

Objective: The objective of this study is to identify and validate the clinical predictors of responses in psoriasis patients treated with tofacitinib.

Methods: Selected baseline characteristics or early improvement in Psoriasis Area and Severity Index (PASI) in the phase 3 tofacitinib study OPT 1 (NCT01276639) were evaluated as predictors for a clinical response (75% improvement in PASI [PASI75]) at week 16. Predictive ability was assessed by the area-under-the-receiver operating characteristic curve (AUC-ROC). The predictive ability of the identified variables was validated with study OPT 2 (NCT01309737).

Results: PASI improvement at weeks 8 and 12 demonstrated good discriminatory abilities to predict PASI75 response at week 16 (AUC-ROC ≥86% and 94%, respectively) in OPT 1. Validation with PASI50 response at week 8 in OPT 2 to predict PASI75 response at week 16 showed that the sensitivity, specificity, PPV, and NPV were 88%, 69%, 80%, and 81%, respectively, in tofacitinib-treated subjects.

Conclusion: Achieving a PASI50 response after 8 weeks of treatment with tofacitinib in psoriasis patients appears to be a reliable predictor of achieving a PASI75 response at week 16. Trial registration: clinicaltrials.gov: NCT01276639 and NCT01309737

Keywords:

• PASI50
• PASI75
• AUC
• early clinical improvement
• predictor of efficacy

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Correction to: Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis

Acknowledgements

The authors would like to thank Supoat Charenkavanich of inVentiv Health Clinical for statistical analysis support.

Disclosure statement

Dr Gordon is a consultant and/or investigator for AbbVie Inc., Amgen Inc., Centocor, Merck, Eli Lilly, Novartis, and Pfizer Inc.

Dr Griffiths has received grants/research support from AbbVie, Actelion, Biotest, Celgene, Eli Lilly, Incyte, Janssen, Leo Pharma, MSD, Novartis, Pfizer Inc., Sandoz, Stiefel UK, Trident, Zymogenetics, and UCB.

Dr Mrowietz has been an advisor and/or received speaker's honoraria and/or received grants and/or participated in clinical trials of the following companies: Abbott/AbbVie, Almirall-Hermal, Amgen, BASF, Biogen Idec, Boehringer-Ingelheim, Celgene, Centocor, Eli Lilly, Foamix, Forward Pharma, Galderma, Janssen, Leo Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, Teva, VBL, and Xenoport.

Drs Tan, Valdez, Tallman, and Wolk are employees and shareholders of Pfizer Inc.

Funding

OPT Pivotal 1 and 2 were funded by Pfizer Inc.