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. J Dermatolog Treat 2017 Feb;28(1):3-7
Date
08/19/2016Pubmed ID
27538247DOI
10.1080/09546634.2016.1214671Scopus ID
2-s2.0-84982252380 (requires institutional sign-in at Scopus site) 8 CitationsAbstract
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.
Author List
Tan H, Valdez H, Griffins CE, Mrowietz U, Tallman A, Wolk R, Gordon KAuthor
Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Administration, OralDouble-Blind Method
Female
Humans
Male
Middle Aged
Piperidines
Psoriasis
Pyrimidines
Pyrroles
ROC Curve
Severity of Illness Index
Treatment Outcome
