Why carry out this study?
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Given the impact of psoriasis on the daily activities and psychology of patients, it is important to collect patients’ insights on their disease in clinical trials to better understand whether the changes in the physical presentation of psoriasis symptoms during the treatment course had any impact on health-related quality of life (HRQoL). |
PURE is a real-world registry evaluating secukinumab and other approved therapies (biologic therapy, oral systemic therapy, and phototherapy) for the management of moderate-to-severe plaque psoriasis in Canada and Latin America. |
In this interim analysis, the effectiveness of secukinumab has been evaluated using Psoriasis Area and Severity Index (PASI) total scores, PASI component sub-scores (erythema, thickening, and scaling), and PASI scores for each body region, for the resolution of symptoms of moderate-to-severe plaque psoriasis up to 36 months, in patients from Canada and Latin America. |
Considering the limited evidence to complement the clinical observations with the impact of psoriasis on patients' HRQoL, we also evaluated the trends in the components of Psoriasis Symptom Diary, a patient-reported outcome tool, up to 36 months in the PURE registry in this analysis. |
What was learned from the study?
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An early and sustained improvement in disease severity was observed with secukinumab treatment as demonstrated by the 36-month results. This improvement was also reflected in different body regions (head/neck, trunk, upper limbs, and lower limbs), where the lower limbs required a relatively longer time for the reduction of disease severity than the other body regions. |
The PASI score components (erythema, thickening, and scaling) demonstrated improvements as early as 3 months and were sustained throughout the follow-up period of 36 months. |
Overall, secukinumab treatment showed a positive impact on disease activity and HRQoL as evaluated using PASI and Psoriasis Symptom Diary, respectively. |
Introduction
Methods
Study Design
Inclusion and Exclusion Criteria
Baseline Demographics and Disease Characteristics
Outcomes Evaluated
Psoriasis Area and Severity Index (PASI)
Psoriasis Symptom Diary
Data Evaluation
Statistical Analysis
Ethical Consideration
Results
Baseline Demographics and Disease Characteristics
Characteristic | Overall (N = 848) | N |
---|---|---|
Age (years) | ||
Mean (± SD) | 49.7 (13.83) | 845 |
Sex, n (%) | ||
Male | 508 (60.0) | 847 |
Race, n (%) | 847 | |
Caucasian | 667 (78.7) | |
Black | 9 (1.1) | |
Asian | 88 (10.4) | |
Pacific Islander | 2 (0.2) | |
American Indian | 7 (0.8) | |
Other | 74 (8.7) | |
Weight (kg) | 805 | |
Mean (± SD) | 91.95 (23.64) | |
PASI total score (range, 0–72) | ||
Mean (± SD) | 13.3 (9.02) | 840 |
Median (range) | 12 (0–71) | |
PASI score—erythema (range, 0–24) | ||
Mean (± SD) | 4.8 (3.21) | 836 |
Median (range) | 4 (0–24) | |
PASI score—thickening (range, 0–24) | ||
Mean (± SD) | 4.3 (3.00) | 836 |
Median (range) | 4 (0–24) | |
PASI score—scaling (range, 0–24) | ||
Mean (± SD) | 4.2 (3.04) | 835 |
Median (range) | 4 (0–24) | |
BSA (%) | ||
Mean (± SD) | 17.0 (15.75) | 839 |
Median (range) | 13 (0–100) | |
Exposure to biologics before study enrollment, n (%) | ||
Yes | 321 (37.9) | 848 |
No | 527 (62.1) | |
Number of biologics used before study enrollment, n (%) | ||
1 | 180 (56.1) | 321 |
2 | 86 (26.8) | |
3 | 36 (11.2) | |
4 or more | 19 (5.9) | |
Time from diagnosis of psoriasis to study enrolment, years | ||
Mean (± SD) | 17.2 (13.12) | 845 |
Baseline medical history, n (%) | Overall (N = 848) |
---|---|
Musculoskeletal and connective tissue disorders | 378 (44.6) |
Psoriatic arthropathy | 189 (22.3) |
Arthralgia | 65 (7.7) |
Osteoarthritis | 46 (5.4) |
Arthritis | 38 (4.5) |
Back pain | 19 (2.2) |
Fibromyalgia | 17 (2.0) |
Rheumatoid arthritis | 11 (1.3) |
Metabolism and nutrition disorders | 311 (36.7) |
Hyperlipidemia | 110 (13.0) |
Diabetes mellitus | 69 (8.1) |
Type 2 diabetes mellitus | 68 (8.0) |
Vascular disorders | 304 (35.8) |
Hypertension | 289 (34.1) |
Psychiatric disorders | 229 (27.0) |
Depression | 111 (13.1) |
Anxiety | 96 (11.3) |
Gastrointestinal disorders | 222 (26.2) |
Gastroesophageal reflux disease | 143 (16.9) |
Irritable bowel syndrome | 20 (2.4) |
Immune system disorders | 208 (24.5) |
Drug hypersensitivity | 112 (13.2) |
Seasonal allergy | 43 (5.1) |
Hypersensitivity | 24 (2.8) |
Food allergy | 22 (2.6) |
Allergy to animals | 14 (1.7) |
Respiratory, thoracic, and mediastinal disorders | 146 (17.2) |
Asthma | 60 (7.1) |
Sleep apnea syndrome | 44 (5.2) |
Chronic obstructive pulmonary disorder | 27 (3.2) |
Infections and infestations | 141 (16.6) |
Latent tuberculosis | 13 (1.5) |
Nervous system disorders | 111 (13.1) |
Migraine | 38 (4.5) |
Headache | 24 (2.8) |
Endocrine disorders | 75 (8.8) |
Hypothyroidism | 67 (7.9) |
Thyroid mass | 3 (0.4) |
Basedow’s disease | 2 (0.2) |
Diabetes insipidus | 1 (0.1) |
Hepatobiliary disorders | 59 (7.0) |
Hepatic steatosis | 28 (3.3) |
Cholelithiasis | 10 (1.2) |
Cardiac disorders | 49 (5.8) |
Myocardial infarction | 12 (1.4) |
General disorders and administration site conditions | 29 (3.4) |
Oedema | 7 (0.8) |
Fatigue | 6 (0.7) |
Pain | 6 (0.7) |
Peripheral swelling | 4 (0.5) |
Effectiveness of Secukinumab
Total PASI Scores
Regional PASI Scores
Baseline | Month 3 | Month 12 | Month 24 | Month 36 | |
---|---|---|---|---|---|
Head/neck | N = 842 | N = 732 | N = 429 | N = 232 | N = 73 |
Erythema, n (%) | |||||
None | 197 (23.4) | 580 (79.2) | 351 (81.8) | 196 (84.5) | 56 (76.7) |
Severe | 154 (18.3) | 9 (1.2) | 6 (1.4) | 1 (0.4) | 0 (0.0) |
Very severe | 33 (3.9) | 2 (0.3) | 1 (0.2) | 0 (0.0) | 0 (0.0) |
Thickening, n (%) | |||||
None | 209 (24.8) | 605 (82.7) | 366 (85.3) | 204 (87.9) | 58 (79.5) |
Severe | 96 (11.4) | 4 (0.5) | 3 (0.7) | 0 (0.0) | 0 (0.0) |
Very severe | 27 (3.2) | 1 (0.1) | 1 (0.2) | 0 (0.0) | 0 (0.0) |
Scaling, n (%) | |||||
None | 196 (23.3) | 585 (79.9) | 354 (82.5) | 198 (85.3) | 57 (78.1) |
Severe | 111 (13.2) | 5 (0.7) | 5 (1.2) | 0 (0.0) | 0 (0.0) |
Very severe | 41 (4.9) | 2 (0.3) | 3 (0.7) | 0 (0.0) | 0 (0.0) |
Trunk | N = 842 | N = 732 | N = 429 | N = 232 | N = 73 |
Erythema, n (%) | |||||
None | 151 (17.9) | 546 (74.6) | 343 (80.0) | 195 (84.1) | 62 (84.9) |
Severe | 266 (31.6) | 24 (3.3) | 11 (2.6) | 7 (3.0) | 1 (1.4) |
Very severe | 62 (7.4) | 3 (0.4) | 3 (0.7) | 2 (0.9) | 0 (0.0) |
Thickening, n (%) | |||||
None | 154 (18.3) | 581 (79.4) | 352 (82.1) | 197 (84.9) | 62 (84.9) |
Severe | 180 (21.4) | 7 (1.0) | 5 (1.2) | 1 (0.4) | 1 (1.4) |
Very severe | 41 (4.9) | 4 (0.5) | 1 (0.2) | 0 (0.0) | 0 (0.0) |
Scaling, n (%) | |||||
None | 166 (19.7) | 588 (80.3) | 355 (82.8) | 201 (86.6) | 62 (84.9) |
Severe | 172 (20.4) | 6 (0.8) | 4 (0.9) | 4 (1.7) | 1 (1.4) |
Very severe | 32 (3.8) | 3 (0.4) | 1 (0.2) | 0 (0.0) | 0 (0.0) |
Upper limb | N = 842 | N = 732 | N = 429 | N = 232 | N = 73 |
Erythema, n (%) | |||||
None | 66 (7.8) | 428 (58.5) | 263 (61.3) | 162 (69.8) | 50 (68.5) |
Severe | 287 (34.1) | 32 (4.4) | 12 (2.8) | 5 (2.2) | 1 (1.4) |
Very severe | 59 (7.0) | 2 (0.3) | 3 (0.7) | 1 (0.4) | 0 (0.0) |
Thickening, n (%) | |||||
None | 72 (8.6) | 444 (60.7) | 273 (63.6) | 165 (71.1) | 49 (67.1) |
Severe | 215 (25.5) | 20 (2.7) | 17 (4.0) | 5 (2.2) | 2 (2.7) |
Very severe | 50 (5.9) | 4 (0.5) | 4 (0.9) | 2 (0.9) | 0 (0.0) |
Scaling, n (%) | |||||
None | 75 (8.9) | 445 (60.8) | 274 (63.9) | 165 (71.1) | 50 (68.5) |
Severe | 203 (24.1) | 18 (2.5) | 14 (3.3) | 3 (1.3) | 2 (2.7) |
Very severe | 45 (5.3) | 3 (0.4) | 4 (0.9) | 2 (0.9) | 0 (0.0) |
Lower limb | N = 842 | N = 732 | N = 428 | N = 232 | N = 73 |
Erythema, n (%) | |||||
None | 44 (5.2) | 373 (51.0) | 252 (58.9) | 144 (62.1) | 44 (60.3) |
Severe | 345 (41.0) | 48 (6.6) | 25 (5.8) | 10 (4.3) | 2 (2.7) |
Very severe | 119 (14.1) | 9 (1.2) | 7 (1.6) | 3 (1.3) | 0 (0.0) |
Thickening, n (%) | |||||
None | 45 (5.3) | 404 (55.2) | 262 (61.2) | 148 (63.8) | 44 (60.3) |
Severe | 275 (32.7) | 30 (4.1) | 15 (3.5) | 7 (3.0) | 3 (4.1) |
Very severe | 70 (8.3) | 7 (1.0) | 3 (0.7) | 1 (0.4) | 0 (0.0) |
Scalinga, n (%) | |||||
None | 49 (5.8) | 405 (55.3) | 259 (60.5) | 148 (63.8) | 45 (61.6) |
Severe | 251 (29.8) | 32 (4.4) | 12 (2.8) | 5 (2.2) | 1 (1.4) |
Very severe | 69 (8.2) | 7 (1.0) | 3 (0.7) | 1 (0.4) | 1 (1.4) |
Total IGA Scores
Psoriasis Symptom Diary Scores
Long-Term Safety of Secukinumab
Characteristics | n (%) |
---|---|
Patients with any AEs | 605 (71.3) |
Any AEs leading to treatment discontinuation* | 120 (14.2) |
Most frequent AEs (by SOC and PT) | |
Infections and infestations | 295 (34.8) |
Upper respiratory tract infection | 63 (7.4) |
Nasopharyngitis | 56 (6.6) |
Bronchitis | 18 (2.1) |
Sinusitis | 16 (1.9) |
Musculoskeletal and connective tissue disorders | 128 (15.1) |
Psoriatic arthropathy | 31 (3.7) |
Arthralgia | 29 (3.4) |
General disorders and administration-site conditions | 109 (12.9) |
Drug ineffective | 41 (4.8) |
Drug effect decreased | 17 (2.0) |
Fatigue | 14 (1.7) |
Injection site reaction | 12 (1.4) |
Gastrointestinal disorders | 103 (12.1) |
Diarrhea | 27 (3.2) |
Nausea | 16 (1.9) |
Gastroesophageal reflux disease | 12 (1.4) |
Nervous system disorders | 71 (8.4) |
Headache | 22 (2.6) |
Vascular disorders | 51 (6.0) |
Hypertension | 37 (4.4) |
Neoplasms benign, malignant and unspecified (including cysts and polyps) | 41 (4.8) |
Skin papilloma | 9 (1.1) |
Basal cell carcinoma | 7 (0.8) |
Seborrheic keratosis | 4 (0.5) |
Cardiac disorders | 16 (1.9) |
Myocardial ischemia | 2 (0.2) |
Acute myocardial infarction | 1 (0.1) |
Myocardial infarction | 1 (0.1) |
Blood and lymphatic system disorders | 9 (1.1) |
Lymphadenopathy | 5 (0.6) |
Anemia | 3 (0.4) |
SAEs | |
Patients with any SAEs | 67 (7.9) |
SAEs leading to treatment discontinuation | 9 (1.1) |
SAEs leading to hospitalization/prolongation of existing hospitalization | 48 (5.7) |
Death | 4 (0.5) |