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Journal of the American Academy of Dermatology
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le jeudi 30 janvier 2020
Doi : 10.1016/j.jaad.2019.12.044
accepted : 17 December 2019
Clinical response rates, placebo response rates, and significantly associated covariates are dependent on choice of outcome measure in hidradenitis suppurativa: A post hoc analysis of PIONEER 1 and 2 individual patient data
 

John W. Frew, MBBS, FACD a, , Caroline S. Jiang, MS b, Neha Singh, MS b, David Grand, BA a, c, Kristina Navrazhina, BA a, d, Roger Vaughan, DrPH b, James G. Krueger, MD, PhD a
a Laboratory of Investigative Dermatology, The Rockefeller University, New York, New York 
b Department of Biostatistics, The Rockefeller University, New York, New York 
c Albert Einstein College of Medicine, Bronx, New York 
d Weill Cornell/Rockefeller/Sloan Kettering Tri-Institutional MD-PhD Program, Weill Cornell University, New York, New York 

John W. Frew, MBBS, FACD, Laboratory of Investigative Dermatology, Rockefeller University, 1230 York Ave, New York, NY 10065.Laboratory of Investigative DermatologyRockefeller University1230 York AveNew YorkNY10065
Abstract
Background

The hidradenitis suppurativa clinical response (HiSCR) is the gold standard primary outcome measure for hidradenitis suppurativa clinical trials; however, it does not assess the presence of draining tunnels, a common finding in advanced disease. It is unclear what the effect of the presence or absence of draining tunnels has on the efficacy of adalimumab therapy in moderate and advanced disease.

Objectives

We evaluated the efficacy of adalimumab versus placebo using the International Hidradenitis Suppurativa Severity Scoring System (IHS4). Additionally, we assessed the effect of draining tunnels on therapeutic response as measured by both the HiSCR and change in nodule counts.

Methods

Reanalysis was conducted with the IHS4 and PIONEER 1 and 2 individual patient data. Both binary outcomes (achieving HiSCR and achieving change in IHS4 severity category) and continuous outcomes (nodule counts and IHS4 score) were calculated with R. Regression modeling was undertaken to assess the effect of draining tunnels and other variables. P  < .05 was considered statistically significant.

Results

The significance of adalimumab therapy depended on the outcome measure used. Placebo response rates were highest when binary outcome measures were used. Draining tunnels, smoking, antibiotics, and body mass index influenced HiSCR response in PIONEER 2. Significant differences in disease severity were observed between PIONEER 1 and 2 data sets.

Conclusions

Elevated placebo response rates in PIONEER 1 and 2 are partially attributable to the use of binary outcome measures. Draining tunnels influence clinical response as measured by HiSCR and nodule counts in PIONEER 2. Further investigation into the effect of body mass index on clinical response is required.

The full text of this article is available in PDF format.

Key words : hidradenitis suppurativa, acne inversa, HiSCR, IHS4, outcome measures, BMI, tunnels, placebo

Abbreviations used : BMI, CI, HiSCR, IHS4, OR



 Funding sources: Dr Frew was supported in part by grant UL1 TR001866 from the National Center for Advancing Translational Sciences, National Institutes of Health (NIH) Clinical and Translational Science Award program. Ms Navrazhina was supported by a Medical Scientist Training Program grant from the National Institute of General Medical Sciences of the NIH under award T32GM007739 to the Weill Cornell/Rockefeller/Sloan Kettering Tri-Institutional MD-PhD Program.
 Conflicts of interest: Dr Krueger has received research support (grants paid to institution) from AbbVie, Amgen, BMS, Boehringer, EMD Serono, Innovaderm, Kineta, LEO Pharma, Novan, Novartis, Paraxel, Pfizer, Regeneron, and Vitae and personal fees from AbbVie, Acros, Allergan, Aurigne, BiogenIdec, Boehringer, Escalier, Janssen, Lilly, Novartis, Pfizer, Roche, and Valeant. Drs Frew and Vaughan and Ms Jiang and Singh, Mr Grand, and Ms Navrazhina have no conflicts of interest to declare.
 This publication was based on research data from AbbVie Inc, which had no input into the design or execution of the study, statistical analysis, or composition of the article.
 Reprints not available from the authors.



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