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 - 14/04/20
, 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 aAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : hidradenitis suppurativa, acne inversa, HiSCR, IHS4, outcome measures, BMI, tunnels, placebo
Abbreviations used : BMI, CI, HiSCR, IHS4, OR
Plan
| 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. |
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| 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. |
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| 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. |
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| Reprints not available from the authors. |
Vol 82 - N° 5
P. 1150-1157 - mai 2020 Retour au numéro
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