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Efficacy and Safety of Ixekizumab in a Randomized, Double-Blinded, Placebo-Controlled Phase 3b Study of Patients with Moderate-to-Severe Genital Psoriasis.

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Presentation on theme: "Efficacy and Safety of Ixekizumab in a Randomized, Double-Blinded, Placebo-Controlled Phase 3b Study of Patients with Moderate-to-Severe Genital Psoriasis."— Presentation transcript:

1 Efficacy and Safety of Ixekizumab in a Randomized, Double-Blinded, Placebo-Controlled Phase 3b Study of Patients with Moderate-to-Severe Genital Psoriasis C Ryan,1 A Menter,2 L Guenther,3 A Blauvelt,4 R Bissonnette,5 K Meeuwis,6 J Sullivan,7 JC Cather,8 G Yosipovitch,9 AB Gottlieb,10 JF Merola,11 K Callis Duffin,12 S Fretzin,13 OO Osuntokun,14 R Burge,14 AN Naegeli,14 FE Yang,14 C-Y Lin,14 K Todd,14 A Potts Bleakman,14 on behalf of the IXORA-Q Study Group 1Department of Dermatology, Blackrock Clinic, Dublin, Ireland 2Department of Dermatology, Baylor University Medical Center, Dallas, TX, USA 3Guenther Dermatology Research Centre, London, ON, Canada 4Oregon Medical Research Center, Portland, OR, USA 5Innovaderm Research, Montreal, QC, Canada 6Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands 7Kingsway Dermatology, Miranda, NSW, Australia 8Modern Research Associates, Dallas, TX, USA 9Department of Dermatology and Itch Center, University of Miami School of Medicine, Miami, FL, USA 10Department of Dermatology, New York Medical College at Metropolitan Hospital, New York, NY, USA 11Department of Dermatology and Medicine, Division of Rheumatology, Harvard Medical School Brigham and Women’s Hospital, Boston, MA, USA 12Department of Dermatology, University of Utah School of Medicine, Salt Lake City, UT, USA 13Dawes Fretzin Dermatology Group, Indianapolis, IN, USA 14Eli Lilly and Company, Indianapolis, IN, USA British Journal of Dermatology. DOI: /bjd.16736

2 Introduction What’s already known?
Genital psoriasis is a common and burdensome form of plaque psoriasis but there are few controlled studies of effective therapies.

3 Objective To determine the efficacy of ixekizumab versus placebo in patients with moderate-to-severe genital psoriasis with BSA≥1%.

4 Methods Study design: Statistical analysis: Patients randomized 1:1
Placebo (PBO): every 2 weeks through week 12 Ixekizumab (IXE): 80 mg IXE every 2 weeks through week 12 (160-mg starting dose at week 0) Statistical analysis: Efficacy: all randomized patients (intention-to-treat analysis) Categorical variables: logistic regression with non-responder imputation Continuous variables: mixed-effects model for repeated measures Safety: randomized patients who received ≥1 dose of investigational product

5 Methods Primary endpoint: Major secondary endpoints:
sPGA-G 0/1: proportion of patients at week 12 achieving clear (0) or minimal (1) on the static Physician’s Global Assessment of Genitalia (sPGA) Major secondary endpoints: Overall sPGA 0/1: proportion of patients at week 12 achieving clear (0) or minimal (1) on the overall sPGA Genital itch NRS ≥3: proportion of patients at week 12 achieving a ≥3-point improvement from baseline on the genital itch numeric rating scale (among patients with a baseline score ≥3) Cont.

6 Methods GenPs-SFQ item 2 0/1: proportion of patients at week 12 achieving a Sexual Frequency Questionnaire (SFQ) item 2 score of 0 or 1 (among patients with a baseline score ≥2) GenPs-SFQ item 2 0/1 indicates sexual activity was never (0) or rarely (1) limited by genital psoriasis

7 Methods Patients: Adults with chronic plaque psoriasis for ≥6 months
Had plaque psoriasis in a non-genital area Had an sPGA-G ≥3, Overall sPGA ≥3, and Body Surface Area (BSA) involvement ≥1% Had previously failed to respond to, or intolerant of, ≥1 topical therapy for genital psoriasis

8 Methods Did not have forms of psoriasis other than plaque psoriasis
Had no pustules or vesicles in the genital area Never received previous treatment with IL-17 antagonists No recent history of suicide attempt or score of 3 on item 12 (thoughts of death or suicide) on the Quick Inventory of Depressive Symptomatology Self Report (16 items)

9 Baseline Characteristics and Safety Outcomes
Baseline demographics and disease characteristics Placebo (N=74) Ixekizumab (N=75) Age, years 44.4 (12.6) 43.1 (13.0) Male, n (%) 57 (77.0) 56 (74.7) Caucasian, n (%) 64 (86.5) 67 (89.3) Weight, kg 95.1 (26.3) 91.9 (23.1) sPGA-G 3.5 (0.5) 3.4 (0.6) Overall sPGA 3.5 (0.6) Genital itch NRS score 6.0 (2.4) 5.9 (2.4) GenPs-SFQ Item 2 score 2.0 (1.6) 1.8 (1.7) % BSA 16.8 (15.7) 14.2 (12.6) 1 to <10%, n (%) 28 (37.8) 31 (41.3) ≥10%, n (%) 46 (62.2) 44 (58.7) Unless otherwise indicated, all values are presented as mean (SD) Adverse events during the blinded treatment period (Week 0-12) of IXORA-Q Placebo N=74 Ixekizumab N=75 Treatment emergent adverse events 33 (44.6) 42 (56.0) Mild 15 (20.3) 23 (30.7) Moderate 18 (24.0) Severe 3 (4.1) 1 (1.3) Serious adverse event 1 (1.4) Discontinuation due to adverse event 5 (6.8) Death Values are presented as n (%) of patients

10 Improvement of Genital Psoriasis During 12 Weeks of Treatment with Ixekizumab
73%*** 56%*** 8% 5% * = p<0.05, ** = p<0.005, *** = p<0.001

11 Overall sPGA, Genital Itch NRS, and GenPs-SFQ Item 2 Response During 12 Weeks of Treatment with Ixekizumab 73%*** 40%*** 78%*** 3% 0% 21% 60%*** 8% * = p<0.05, ** = p<0.005, *** = p<0.001

12 Discussion Ixekizumab was superior to placebo for the treatment of moderate-to-severe genital psoriasis at week 12. Response was rapid, with significant improvements observed as early as week 1. Improvement in genital psoriasis was consistent in patients with both lower (1 to <10%) and higher (≥10%) BSA involvement. Safety profile was consistent with other studies of ixekizumab in overall psoriasis and psoriatic arthritis.

13 Discussion Strengths: Limitations:
The only phase 3, randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy of any therapy for the treatment of genital psoriasis. The study population was globally diverse (34 sites in 7 countries). Included patients with both lower and higher BSA involvement. Limitations: No active comparator as there are no well-established treatments for genital psoriasis. Predominantly Caucasian and male study population. Short duration of treatment (study is ongoing to collect longer term results).

14 Discussion Although a common and burdensome form of psoriasis, only a few open-label studies have evaluated the efficacy of treatments for genital psoriasis. Ixekizumab provided rapid and significant improvement in genital psoriasis compared to placebo, with consistent improvement across BSA subgroups.

15 Conclusions What does this study add?
Ixekizumab significantly improved the severity of genital psoriasis and associated disease characteristics. Ixekizumab may be appropriate for moderate-to-severe genital psoriasis treatment, even in patients with limited body surface involvement.

16 Call for correspondence
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