Alice B Gottlieb1, Jashin J Wu2, Christopher E M Griffiths3, Kwaku Marfo4, Elisa Muscianisi5, Xiangyi Meng5, Jennifer Frueh4, Mark Lebwohl1. 1. Icahn School of Medicine at Mount Sinai, New York, NY, USA. 2. Dermatology Research and Education Foundation, Irvine, CA, USA. 3. Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, The University of Manchester, Manchester, UK. 4. Novartis Pharma AG, Basel, Switzerland. 5. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Abstract
BACKGROUND: The influence of comorbidities on the efficacy and safety of biologic therapies in psoriasis has not been rigorously explored. OBJECTIVE: To assess the incremental burden of comorbidities on clinical efficacy and safety of secukinumab vs. etanercept and placebo among patients with plaque psoriasis pooled from 4 phase 3 trials. METHODS: Efficacy was assessed at week 12 according to achievement of Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA; modified 2011) responses. Efficacy comparisons between treatment arms stratified by comorbidity status were made using logistic regression analysis with nonresponder imputation. Relationships between baseline characteristics and clinical responses were evaluated by χ2 tests. RESULTS: Of 2401 patients, 1469 (61.2%) had ≥1 active baseline comorbidity. Regardless of comorbidity status, patients receiving secukinumab were more likely to achieve PASI and IGA responses than those receiving etanercept or placebo at week 12 (p < .05 for all comparisons). Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses (p < .01 for all comparisons). Safety was comparable across treatment arms stratified by comorbidity. CONCLUSIONS: Secukinumab improved clinical outcomes and was well tolerated in patients with concomitant baseline comorbid conditions.
BACKGROUND: The influence of comorbidities on the efficacy and safety of biologic therapies in psoriasis has not been rigorously explored. OBJECTIVE: To assess the incremental burden of comorbidities on clinical efficacy and safety of secukinumab vs. etanercept and placebo among patients with plaque psoriasis pooled from 4 phase 3 trials. METHODS: Efficacy was assessed at week 12 according to achievement of Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA; modified 2011) responses. Efficacy comparisons between treatment arms stratified by comorbidity status were made using logistic regression analysis with nonresponder imputation. Relationships between baseline characteristics and clinical responses were evaluated by χ2 tests. RESULTS: Of 2401 patients, 1469 (61.2%) had ≥1 active baseline comorbidity. Regardless of comorbidity status, patients receiving secukinumab were more likely to achieve PASI and IGA responses than those receiving etanercept or placebo at week 12 (p < .05 for all comparisons). Body weight of ≥90 kg was consistently associated with a decreased likelihood of achieving PASI and IGA responses (p < .01 for all comparisons). Safety was comparable across treatment arms stratified by comorbidity. CONCLUSIONS: Secukinumab improved clinical outcomes and was well tolerated in patients with concomitant baseline comorbid conditions.
Authors: Giovanni Damiani; Giulia Odorici; Alessia Pacifico; Aldo Morrone; Rosalynn R Z Conic; Tima Davidson; Abdulla Watad; Paolo D M Pigatto; Delia Colombo; Piergiorgio Malagoli; Marco Fiore Journal: Pharmaceuticals (Basel) Date: 2022-01-14