Why carry out this study?
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Secukinumab has shown rapid and sustained effectiveness with a favourable safety profile in the treatment of moderate-to-severe plaque psoriasis and its manifestations in real-world studies |
There is limited information on clinical data pertaining to outcomes with secukinumab use for psoriasis in Latin America. In addition, variation exists between patients (severity of disease and other patient characteristics), physician perspectives (drug prescription patterns) and health care systems (clinical practice, local guideline–driven management of disease and reimbursement policies) in routine clinical practice |
This study was conducted to assess the effectiveness and safety of secukinumab in a Latin American population |
What was learned from the study?
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The current study provides data on the real-world effectiveness of secukinumab in Latin American patients with moderate-to-severe plaque psoriasis |
The 12-month follow-up data from the PURE registry demonstrated improvements in psoriasis disease severity and a positive impact on quality of life with secukinumab treatment in a clinical setting |
The findings from this interim analysis are likely to support an evidence-based framework for clinical decisions on treating patients with chronic plaque psoriasis in Latin America |
Introduction
Methods
Study Design
Inclusion and Exclusion Criteria
Baseline Assessments
Outcome Measures and Variables
Statistical Analysis
Ethical Considerations
Results
Patient Population
Demographics and Baseline Disease Characteristics
Characteristics | Secukinumab N = 89 | Other Tx N = 98 | Overall N = 187 |
---|---|---|---|
Age (years), mean (SD) | 49.1 (12.9) | 45.6 (16.5) | 47.2 (15.0) |
Male, n (%) | 46 (51.7) | 53 (54.1) | 99 (52.9) |
Race, n (%) | |||
Caucasian | 44 (50.6) | 46 (46.9) | 90 (48.6) |
American Indian | 6 (6.9) | 2 (2.0) | 8 (4.3) |
Other | 37 (42.5) | 50 (51.0) | 87 (47.0) |
BMI (kg/m2), mean ± SD | 28.4 (5.4) | 27.7 (6.2) | 28.0 (5.8) |
Duration since first diagnosis of psoriasis (years), mean (SD) | 13.8 (12.3) | 10.8 (11.1) | 12.3 (11.7) |
Subjects with any current psoriasis therapies at baseline, n (%) | 75 (84.3) | 84 (85.7) | 159 (85.0) |
PASI total score, mean ± SD | 16.6 (9.51) | 15.5 (7.59) | 16.0 (8.56) |
Baseline IGA score, n (%) | |||
Moderate disease | 49 (57.0) | 63 (65.6) | 112 (61.5) |
Severe disease | 33 (38.4) | 26 (27.1) | 59 (32.4) |
DLQI total score, mean ±SD | 11.5 (7.1) | 11.5 (7.6) | 11.5 (7.4) |
Treatment Effectiveness
Skin Disease-Related Quality of Life
Safety
Events | Secukinumab N = 89 | Other Tx N = 98 | Overall N = 187 |
---|---|---|---|
Number of participants with any AEs, n (%) | 34 (38.2) | 35 (35.7) | 69 (36.9) |
EAIRa of AEs/100 PY | |||
AEs | 49.6 | 48.7 | 49.1 |
Serious AEs | 6.7 | 3.7 | 5.1 |
AEs related to study treatment | 14.8 | 25.9 | 20.6 |
Severe AEs | 5.4 | 1.8 | 3.5 |
AEs leading to study dose permanently discontinued | 5.4 | 2.5 | 3.9 |
AEs leading to hospitalization/prolongation of existing hospitalization | 6.0 | 3.1 | 4.5 |
AEs leading to death | 0.7 | 0.0 | 0.3 |
Serious AEs related to study treatment | 4.7 | 1.8 | 3.2 |
AEs by SOC (≥ 5%), n (%) | |||
Gastrointestinal disorders | 6 (6.7) | 5 (5.1) | 11 (5.9) |
Infections and infestations | 13 (14.6) | 19 (19.4) | 32 (17.1) |
Skin and subcutaneous tissue disorders | 4 (4.5) | 6 (6.1) | 10 (5.3) |
AEs by SOC (≥ 5%), by severity, n (%) | |||
Overall | |||
Total | 32 (36) | 34 (34.7) | 66 (35.3) |
Mild | 17 (19.1) | 22 (22.4) | 39 (20.9) |
Moderate | 12 (13.5) | 10 (10.2) | 22 (11.8) |
Severe | 5 (5.6) | 3 (3.1) | 8 (4.3) |
Gastrointestinal disorders | |||
Total | 6 (6.7) | 5 (5.1) | 11 (5.9) |
Mild | 3 (3.4) | 5 (5.1) | 8 (4.3) |
Moderate | 2 (2.2) | 0 (0.0) | 2 (1.1) |
Severe | 1 (1.1) | 0 (0.0) | 1 (0.5) |
Infections and infestations | |||
Total | 13 (14.6) | 19 (19.4) | 32 (17.1) |
Mild | 8 (9.0) | 14 (14.3) | 22 (11.8) |
Moderate | 3 (3.4) | 4 (4.1) | 7 (3.7) |
Severe | 2 (2.2) | 1 (1.0) | 3 (1.6) |
Skin and subcutaneous tissue disorders | |||
Total | 4 (4.5) | 6 (6.1) | 10 (5.3) |
Mild | 3 (3.4) | 4 (4.1) | 7 (3.7) |
Moderate | 1 (1.1) | 2 (2.0) | 3 (1.6) |
Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Number of participants with any SAEs, n (%) | 5 (5.6) | 4 (4.1) | 9 (4.8) |
Death, n (%) | 1 (1.1) | 0 (0.0) | 1 (0.5) |