Background Tildrakizumab is a high-affinity, humanized, IgG1/κ, anti-IL-23p19 monoclonal antibody that has demonstrated efficacy in the treatment of chronic plaque psoriasis, a disorder associated with significant quality-of-life impairment.
Objectives This analysis evaluated Dermatology Life Quality Index (DLQI) questionnaire responses to assess how clinical improvements with tildrakizumab affect specific areas of daily life in psoriasis patients.
Methods This randomized, controlled study (NCT01225731) included 355 patients with moderate-to-severe chronic plaque psoriasis who were randomized to receive placebo, tildrakizumab 5 mg, 25 mg, 100 mg, or 200 mg for 16 weeks in Part 1 of the study. The primary endpoint was the proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI 75). Patients completed the Dermatology Life Quality Index (DLQI) questionnaire to assess the effect of treatment on health-related quality of life. Responses to individual DLQI questions were scored in terms of the level of impairment due to psoriasis: 3 (Very Much) to 0 (Not Relevant or Not at All). Individual questions were grouped and assessed in following categories: Symptoms/Feelings (total score of 6); Daily Activities (total score of 6); Leisure (total score of 6); Work/School (total score of 3); Personal Relationships (total score of 6); Treatment (total score of 3)(1). A change of at least 4 points in the overall score is considered a clinically important change(2).
Results There were 339 patients who completed 16 weeks of treatment. PASI 75 responses at Week 16 were 33.3%, 64.4%, 66.3%, 74.4% and 4.4%, in the 5 mg, 25 mg, 100 mg, 200 mg tildrakizumab and placebo groups, respectively (p≤0.001 vs. placebo); mean changes (95% CI) from baseline in DLQI were associated with PASI 75 responses and are presented in the Table (3). All tildrakizumab doses were associated with a clinically important change (>4 points)(2). Mean changes from baseline to Week 16 in individual DLQI categories are presented (Table). Tildrakizumab 25 mg, 100 mg, and 200 mg doses were associated with the largest improvements in individual categories, particularly in Symptoms/Feelings and Daily Activities.
Conclusions Treatment of chronic plaque psoriasis with tildrakizumab was associated with clinically important changes in DLQI including improvements in symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment categories that were correlated with improvements in PASI scores.
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Disclosure of Interest D. Thaçi Consultant for: Abbott (AbbVie), Almiral, Amgen, Astellas, Biogen Idec, Boehringer Ingelheim, Celgene, Dignity, Forward Pharma, Galderma, GlaxoSmithKline, Isotechnika, Janssen-Cilag, LEO Pharma, Lilly, Maruho, Medac, Medimmune, MSD, Merck Serono, Novartis, Regeneron, Sandoz, Sanofi-Aventis, Takeda and Pfizer., K. Papp Consultant for: Abbott (AbbVie), Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Centocor, Foreward Pharma, Galderma, Genentech, Incyte, Isotechnika, Janssen, Kyowa Kirin, LEO Pharma, Lilly, Medimmune, MSD, Merck Serono, Novartis, Regeneron, Stiefel, Takeda, Pfizer and USB., K. Reich Consultant for: AbbVie, Amgen, Biogen Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Lilly, Medac, Merck, Novartis, Pfizer, Vertex and Takeda., R. Langley Consultant for: AbbVie, Celgene, Centocor, Janssen-Cilag, LEO Pharma, Merck & Co., Inc., Novartis and Pfizer., A. Mehta Employee of: Merck & Co., Inc., Q. Li Employee of: Merck & Co., Inc., C. La Rosa Employee of: Merck & Co., Inc.