Faculty Collaboration Database

Poor early response to methotrexate portends inadequate long-term outcomes in patients with moderate-to-severe psoriasis: Evidence from 2 phase 3 clinical trials. J Am Acad Dermatol 2017 Dec;77(6):1030-1037

Date

10/11/2017

Pubmed ID

28993007

DOI

10.1016/j.jaad.2017.08.017

Scopus ID

2-s2.0-85030755527 (requires institutional sign-in at Scopus site)   7 Citations

Abstract

BACKGROUND: Most methotrexate-treated psoriasis patients do not achieve a long-term PASI75 (75% reduction from baseline Psoriasis Area and Severity Index score) response. Indications of nonresponse can be apparent after only 4 weeks of treatment.

OBJECTIVE: To develop a prediction rule to identify patients unlikely to respond adequately to methotrexate.

METHODS: Patient-level data from CHAMPION (NCT00235820, N = 110) was used to construct a prediction model for week 16 PASI75 by using patient baseline characteristics and week 4 PASI25. A prediction rule was determined on the basis of the sensitivity and specificity and validated in terms of week 16 PASI75 response in an independent validation sample from trial M10-255 (NCT00679731, N = 163).

RESULTS: PASI25 achievement at week 4 (odds ratio = 8.917) was highly predictive of response with methotrexate at week 16. Patients with a predicted response probability <30% were recommended to discontinue methotrexate. The rates of week 16 PASI75 response were 65.8% and 21.1% (P < .001) for patients recommended to continue and discontinue methotrexate, respectively.

LIMITATIONS: The CHAMPION trial excluded patients previously treated with biologics, and the M10-255 trial had no restrictions.

CONCLUSION: A prediction rule was developed and validated to identify patients unlikely to respond adequately to methotrexate. The rule indicates that 4 weeks of methotrexate might be sufficient to predict long-term response with limited safety risk.

Author List

Gordon KB, Betts KA, Sundaram M, Signorovitch JE, Li J, Xie M, Wu EQ, Okun MM

Author

Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Dermatologic Agents
Female
Humans
Male
Methotrexate
Models, Statistical
Prognosis
Psoriasis
Severity of Illness Index
Time Factors
Treatment Outcome