Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to- severe plaque psoriasis up to 1 year: Results from the CLEAR study

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Presentation transcript:

Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to- severe plaque psoriasis up to 1 year: Results from the CLEAR study Andrew Blauvelt, MD, MBA, Kristian Reich, MD, Tsen-Fang Tsai, MD, Stephen Tyring, MD, PhD, Francisco Vanaclocha, MD, Külli Kingo, MD, PhD, Michael Ziv, MD, BSc, Andreas Pinter, MD, Ronald Vender, MD, FRCPC, Sophie Hugot, MSc, Ruquan You, MSc, Marina Milutinovic, MD, Diamant Thaçi, MD Journal of the American Academy of Dermatology Volume 76, Issue 1, Pages 60-69.e9 (January 2017) DOI: 10.1016/j.jaad.2016.08.008 Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Study design to week 52. ↓ = Active dose administration; to keep the study blinded, subjects in the ustekinumab treatment group received placebo secukinumab injections. *Ustekinumab dose was based on body weight per label: 45 mg for subjects ≤100 kg and 90 mg for subjects >100 kg. BL, Baseline; PASI 75/90, ≥75%/≥90% improvement from baseline Psoriasis Area and Severity Index score. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 PASI 90 (A), PASI 100 (B), PASI 75 (C), and IGA 0/1 (D) responses until week 52. Missing data were handled using multiple imputation. *P < .05, †P < .01, and ‡P < .001 vs ustekinumab by logistic regression. IGA mod 2011 0/1, Investigator's Global Assessment, 2011 modified version, score 0/1; PASI 75/90/100, ≥75%/≥90%/100% improvement from baseline Psoriasis Area and Severity Index score. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Proportions of subjects with a DLQI score 0 or 1 over time. Missing data were imputed with last observation carried forward. *P < .05 and †P < .001 vs ustekinumab by the Fisher's exact test. DLQI, Dermatology Life Quality Index. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 A, Percentages of subjects with impairment* in EQ-5D-3L domains at baseline and week 52. B, Percentage reductions in impairment on the WPAI-PSO from baseline to week 52. Missing data were imputed with the last observation carried forward. *Subjects rated their level of impairment in each dimension with 1 of 3 categories of response (no problem, moderate problem, or severe problems); this figure shows the percentages of subjects who reported moderate or severe problems in each dimension. †P < .01 vs ustekinumab by analysis of covariance. EQ-5D, EuroQoL 5-Dimension Health Questionnaire (EQ-5D; version EQ-5D-3L); WPAI-PSO, Work Productivity and Activity Impairment Questionnaire-Psoriasis. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Percentages of subjects with concomitant PsA exhibiting HAQ-DI response* over time. Missing data were imputed with the last observation carried forward. *HAQ-DI response was defined as a decrease in score of at least 0.3 from baseline, the minimum clinically important difference (score range: 0-3). HAQ-DI, Health Assessment Questionnaire-Disability Index. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 1 Subject disposition. *Four subjects did not receive study treatment (2 withdrew consent: 1 due to a technical problem and 1 due to physician decision) and discontinued the study at randomization; 1 was excluded from all analyses because the informed consent form was obtained the day after a study-related procedure. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 2 PASI 90 response rates at week 16 and week 52: secukinumab vs. ustekinumab 45 mg or 90 mg. Missing data were handled by using nonresponder imputation. PASI 90, ≥90% improvement from baseline Psoriasis Area and Severity Index score. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 3 PASI 90 response rates at week 16 (A) and week 52 (B) by previous psoriasis therapy exposure. Missing data were handled by using multiple imputation. P values by logistic regression. PASI 90, ≥90% improvement from baseline Psoriasis Area and Severity Index score. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 4 PASI 90 responses to week 52 in the subgroup with concomitant psoriatic arthritis at baseline. Missing data were handled by using nonresponder imputation. *P < .05, †P < .01, and ‡P < .001 vs ustekinumab by logistic regression. PASI 90, ≥90% improvement from baseline Psoriasis Area and Severity Index score. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 5 Subject's assessment of psoriasis-related pain (A), itching (B), and scaling (C) over time. Missing data were handled by using last observation carried forward. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 6 Mean percentage improvements from baseline in DLQI total score and individual subscales at week 52. Missing data were imputed with last observation carried forward. *P = .0002 vs ustekinumab by the van Elteren test. P values for subscales were not assessed. DLQI, Dermatology Life Quality Index. Journal of the American Academy of Dermatology 2017 76, 60-69.e9DOI: (10.1016/j.jaad.2016.08.008) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions