K B Gordon1, K Reich2, J J Crowley3, N J Korman4, F T Murphy5,6, Y Poulin7,8, L Spelman9,10, P S Yamauchi11, A M Mendelsohn12, J Parno12, S J Rozzo12, C N Ellis13. 1. Medical College of Wisconsin, Milwaukee, WI, USA. 2. Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation®, Hamburg, Germany. 3. Bakersfield Dermatology, Bakersfield, CA, USA. 4. University Hospital Cleveland Medical Center, Cleveland, OH, USA. 5. Altoona Arthritis and Osteoporosis Center, Duncansville, PA, USA. 6. Villanova University, Villanova, PA, USA. 7. Centre Hospitalier de l'Université Laval, Hôpital Hôtel-Dieu de Québec, Québec City, QC, Canada. 8. Centre de Recherche Dermatologique du Québec Métropolitain, Québec City, QC, Canada. 9. Veracity Clinical Research, Brisbane, QLD, Australia. 10. Probity Medical Research, Waterloo, ON, Canada. 11. David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. 12. Sun Pharmaceutical Industries, Inc, Princeton, NJ, USA. 13. Department of Dermatology, University of Michigan Medical School, Ann Arbor, MI, USA.
Abstract
BACKGROUND: It is unclear whether primary efficacy outcomes in plaque psoriasis clinical trials represent residual disease during treatment. OBJECTIVES: To evaluate supplementing dichotomous efficacy with residual disease activity. METHODS: This post hoc analysis used pooled, patient-level data after tildrakizumab 100 mg (N = 616) or placebo (N = 309) treatment from reSURFACE 1/2 (NCT01722331/NCT01729754) phase 3 clinical trials of patients with moderate to severe plaque psoriasis. RESULTS: Median baseline Psoriasis Area and Severity Index (PASI) was 17.9 for patients receiving tildrakizumab 100 mg. At Week 12, median PASI was 2.9, whereas dichotomous PASI 90 response rate was 36.9%, and absolute PASI <5.0, <3.0, and <1.0 were 64.0%, 50.8%, and 23.3%, respectively. At Week 28, median PASI was 1.7, whereas PASI 90 response rate was 51.9%, and absolute PASI <5.0, <3.0, and <1.0 were 75.3%, 62.8%, and 38.0%, respectively. Dermatology Life Quality Index and PASI scores were correlated through Week 28 (r = 0.51, p ≤ .0001). CONCLUSIONS: Disease activity was more reliably estimated by PASI scores than percentage PASI improvement; this may partially explain efficacy disparities between clinical trials and practice. These results suggest supplementing dichotomous PASI improvement with PASI scores and consideration of patient treatment goals could facilitate clinical decisions.
BACKGROUND: It is unclear whether primary efficacy outcomes in plaque psoriasis clinical trials represent residual disease during treatment. OBJECTIVES: To evaluate supplementing dichotomous efficacy with residual disease activity. METHODS: This post hoc analysis used pooled, patient-level data after tildrakizumab 100 mg (N = 616) or placebo (N = 309) treatment from reSURFACE 1/2 (NCT01722331/NCT01729754) phase 3 clinical trials of patients with moderate to severe plaque psoriasis. RESULTS: Median baseline Psoriasis Area and Severity Index (PASI) was 17.9 for patients receiving tildrakizumab 100 mg. At Week 12, median PASI was 2.9, whereas dichotomous PASI 90 response rate was 36.9%, and absolute PASI <5.0, <3.0, and <1.0 were 64.0%, 50.8%, and 23.3%, respectively. At Week 28, median PASI was 1.7, whereas PASI 90 response rate was 51.9%, and absolute PASI <5.0, <3.0, and <1.0 were 75.3%, 62.8%, and 38.0%, respectively. Dermatology Life Quality Index and PASI scores were correlated through Week 28 (r = 0.51, p ≤ .0001). CONCLUSIONS: Disease activity was more reliably estimated by PASI scores than percentage PASI improvement; this may partially explain efficacy disparities between clinical trials and practice. These results suggest supplementing dichotomous PASI improvement with PASI scores and consideration of patient treatment goals could facilitate clinical decisions.
Entities:
Keywords:
Psoriasis; Psoriasis Area and Severity Index (PASI); disease activity; tildrakizumab
Authors: Finola M Bruins; Maartje R Van Acht; Inge M G J Bronckers; Hans M M Groenewoud; Elke M G J De Jong; Marieke M B Seyger Journal: Acta Derm Venereol Date: 2022-06-29 Impact factor: 3.875
Authors: Paolo Gisondi; Marina Talamonti; Andrea Chiricozzi; Stefano Piaserico; Paolo Amerio; Anna Balato; Federico Bardazzi; Piergiacomo Calzavara Pinton; Anna Campanati; Angelo Cattaneo; Paolo Dapavo; Clara De Simone; Valentina Dini; Maria C Fargnoli; Maria L Flori; Marco Galluzzo; Claudio Guarneri; Claudia Lasagni; Francesco Loconsole; Ada Lo Schiavo; Piergiorgio Malagoli; Giovanna Malara; Santo R Mercuri; Maria L Musumeci; Luigi Naldi; Manuela Papini; Aurora Parodi; Concetta Potenza; Francesca Prignano; Franco Rongioletti; Luca Stingeni; Rossana Tiberio; Marina Venturini; Luca Bianchi; Antonio Costanzo; Francesco Cusano; Giampiero Girolomoni; Anna M Offidani; Ketty Peris Journal: Dermatol Ther (Heidelb) Date: 2021-01-11
Authors: Alice B Gottlieb; Richard B Warren; Matthias Augustin; Llenalia Garcia; Christopher Cioffi; Luke Peterson; Christopher Pelligra; Valerie Ciaravino Journal: Adv Ther Date: 2021-09-02 Impact factor: 3.845