Why carry out this study?
|
Plaque psoriasis is a common, chronic immunologic disorder with an estimated prevalence ranging from approximately 1.0 to 8.5% worldwide and a negative impact on quality of life. |
Psoriasis is a chronic, lifelong disease, and it is therefore essential to understand the long-term efficacy and safety profile of psoriasis treatments. |
In this report, we present the 5-year efficacy and safety outcomes from the long-term extension periods of the UNCOVER-1 and UNCOVER-2 studies, phase-3 randomized-controlled trials in patients with moderate-to-severe psoriasis treated with the labeled dose of ixekizumab. |
What was learned from this study?
|
Ixekizumab therapy provided long-lasting efficacy in patients with psoriasis over 5 years of treatment. |
No unexpected safety signals were reported with long-term exposure to ixekizumab in this study. |
100% improvement in psoriasis severity (Psoriasis Area and Severity Index 100) was strongly associated with good patient-reported quality of life (Dermatology Life Quality Index 0,1) through 5 years, showing clear skin over long periods is the optimal treatment outcome for patients with psoriasis. |
Introduction
Methods
Study Design
Study Objectives
Compliance with Ethics Guidelines
Statistical Methods
Results
Baseline Characteristics and Patient Disposition
Characteristics | IXE Q2W/IXE Q4W 80 mg (N = 206) |
---|---|
Sex, n (%) | |
Male | 140 (68.0) |
Age (years), median (range) | 43.0 (18–77) |
Race, n (%) | |
Caucasian | 193 (93.7) |
Asian | 8 (3.9) |
Black or African American | 3 (1.5) |
Multiple | 2 (1.0) |
Geographic region, n (%) | |
North America | 102 (49.5) |
USA | 59 (28.6) |
Europe | 95 (46.1) |
Asia | 3 (1.5) |
Australia | 6 (2.9) |
Height (cm), median (range) | 173.15 (146.0–196.0) |
Weight (kg), median (range) | 88.25 (50.0–160.0) |
BMI (kg/m2), median (range) | 29.25 (17.5–55.3) |
Tobacco use, n (%) | 69 ( 33.5) |
Alcohol consumption, n (%) | 122 ( 59.2) |
Duration of psoriasis symptoms (years), mean (SD)a | 18.6 (12.3) |
Age of psoriasis onset (years), mean (SD) | 25.4 (12.5) |
Baseline efficacy/patient-reported outcome scores | |
PASI, mean (SD) | 19.3 (6.9) |
sPGA, mean (SD) | 3.5 (0.6) |
DLQI, mean (SD) | 12.1 (6.9) |
BSA involvement (%), mean (SD) | 27.1 (16.2) |
PsA present, n (%) | 49 (23.8) |
Previous systemic therapy, n (%) | |
Never used | 65 (31.6) |
Non-biologic onlyb | 72 (35.0) |
Biologic only | 16 (7.8) |
Biologic and non-biologic | 53 (25.7) |
Previous biologic therapy, n (%) | 69 (33.5) |
Previous phototherapy, n (%) | 93 ( 45.1) |
Previous non-biologic systemic therapy, n (%) | |
Never used | 81 (39.3) |
Used 1 therapy | 60 (29.1) |
Used 2 therapies | 36 (17.5) |
Used ≥ 3 therapies | 29 (14.1) |
Previous non-biologic systemic therapy: inadequate response, intolerance or contraindication, n (%) | |
Used < 3 therapies | 185 (89.8) |
Used ≥ 3 therapies | 21 (10.2) |
Disposition status | IXE Q2W/IXE Q4Wa 80 mg (N = 206) |
---|---|
Number of patients (%) | |
Completed | 172 (83.5) |
Discontinued | 34 (16.5) |
Reasons for discontinuation, n (%) | |
Adverse event | 7 (3.4) |
Related to study drug | 0 |
Patient decision | 12 (5.8) |
Investigator decision | 5 (2.4) |
Lack of efficacy | 3 (1.5) |
Lost to follow-up | 4 (1.9) |
Clinical relapse | 1 (0.5) |
Parent/caregiver decision | 1 (0.5) |
Protocol violation | 1 (0.5) |
Efficacy Outcomes Over 5 Years of Treatment
Patient-Reported Outcome: Dermatology Life Quality Index over 5 Years of Treatment
Safety Profile
Parameter | IXE Q2W/IXE Q4Wa 80 mg | |||||
---|---|---|---|---|---|---|
Year 1 205.1 Total PYb | Year 2 195.4 Total PYb | Year 3 165.6 Total PYb | Year 4 136.4 Total PYb | Year 5 119.5 Total PYb | LTE Period 604.3 Total PYb | |
n (IR) | n (IR) | n (IR) | n (IR) | n (IR) | n (IR) | |
Any TEAE(s) | 183 (89.2) | 139 (71.1) | 133 (80.3) | 116 (85.1) | 103 (86.2) | 190 (31.4) |
SAEs | 5 (2.4) | 19 (9.7) | 12 (7.2) | 12 (8.8) | 11 (9.2) | 41 (6.8) |
Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
Discontinued due to AEs | 0 | 1 (0.5) | 3 (1.8) | 3 (2.2) | 0 | 7 (1.2) |
Most frequent TEAEs | ||||||
Nasopharyngitis | 43 (21.0) | 26 (13.3) | 25 (15.1) | 21 (15.4) | 21 (17.6) | 61 (10.1) |
Upper respiratory tract infection | 31 (15.1) | 19 (9.7) | 14 (8.5) | 13 (9.5) | 6 (5.0) | 37 (6.1) |
TEAE severity | ||||||
Mild | 80 (39.0) | 62 (31.7) | 55 (33.2) | 47 (34.5) | 38 (31.8) | 48 (7.9) |
Moderate | 90 (43.9) | 63 (32.2) | 64 (38.6) | 59 (43.3) | 49 (41.0) | 102 (16.9) |
Severe | 13 (6.3) | 14 (7.2) | 14 (8.5) | 10 (7.3) | 16 (13.4) | 40 (6.6) |
AESIs | ||||||
Infection | 139 (67.8) | 87 (44.5) | 78 (47.1) | 67 (49.1) | 64 (53.5) | 150 (24.8) |
Allergic reactions/hypersensitivities | ||||||
Non-anaphylaxis | 24 (11.7) | 11 (5.6) | 8 (4.8) | 9 (6.6) | 4 (3.3) | 28 (4.6) |
Anaphylaxis | 0 | 0 | 0 | 0 | 0 | 0 |
Hepatic | 12 (5.9) | 4 (2.0) | 5 (3.0) | 4 (2.9) | 4 (3.3) | 14 (2.3) |
Cytopenias | 5 (2.4) | 4 (2.0) | 4 (2.4) | 3 (2.2) | 4 (3.3) | 11 (1.8) |
Injection-site reactions | 47 (22.9) | 12 (6.1) | 3 (1.8) | 3 (2.2) | 1 (0.8) | 12 (2.0) |
Cerebro-cardiovascular events | 0 | 1 (0.5) | 3 (1.8) | 2 (1.5) | 0 | 6 (1.0) |
Depression | 0 | 2 (1.0) | 4 (2.4) | 3 (2.2) | 1 (0.8) | 9 (1.5) |
Malignancies | 1 (0.5) | 1 (0.5) | 0 | 2 (1.5) | 0 | 3 (0.5) |
Crohn's disease | 0 | 1 (0.5) | 0 | 0 | 0 | 0 |
Pneumocystis pneumonia | 0 | 0 | 0 | 0 | 0 | 0 |
Interstitial lung disease | 0 | 0 | 0 | 0 | 0 | 0 |
Ulcerative colitis | 0 | 0 | 0 | 0 | 0 | 0 |