Why carry out this study?
|
Obesity, smoking, and alcohol consumption are prevalent in patients with psoriasis. |
These lifestyle risk factors have been associated with increased psoriasis severity, limited systemic treatment options, and reduced treatment response. |
This analysis compared the efficacy of brodalumab versus ustekinumab in patients with moderate-to-severe psoriasis with or without the presence of at least one of these three aggravating lifestyle risk factors at baseline. |
What was learned from the study?
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This post hoc analysis of pooled data from the phase 3 AMAGINE-2 and -3 trials found higher levels of complete skin clearance and quality of life were achieved and maintained with brodalumab versus ustekinumab in patients with moderate-to-severe psoriasis, regardless of the presence of lifestyle risk factors. |
Brodalumab may offer a good treatment option for psoriasis patients who have a history of aggravating lifestyle risk factors. |
Introduction
Methods
Study Design and Patients
Assessments
Lifestyle Risk Factors
Disease Severity, Response, and QoL
Responder Analyses for Clearance (PASI100), DLQI 0/1, and PSI ≤ 8 at a Given Time Point by Risk Factor History
Competing Risk Model by Risk Factor History
Results
Patients
Characteristic | No risk factors | One risk factor | Two risk factors | Three risk factors | ||||
---|---|---|---|---|---|---|---|---|
Brodalumab (n = 51) | Ustekinumab (n = 76) | Brodalumab (n = 140) | Ustekinumab (n = 221) | Brodalumab (n = 122) | Ustekinumab (n = 236) | Brodalumab (n = 26) | Ustekinumab (n = 57) | |
Male, n (%) | 34 (66.7) | 48 (63.2) | 93 (66.4) | 144 (65.2) | 82 (67.2) | 170 (72.0) | 21 (80.8) | 42 (73.7) |
Age, years | 47.2 (14.7) | 40.8 (13.9) | 44.7 (13.4) | 45.9 (12.9) | 43.3 (13.2) | 46.4 (12.7) | 44.3 (11.9) | 42.6 (12.6) |
Weight, kg | 75.5 (10.8) | 75.8 (12.0) | 88.0 (23.9) | 85.7 (19.8) | 96.7 (26.9) | 96.9 (23.8) | 102.5 (12.3) | 107.5 (23.3) |
BMI, kg/m2 | 25.7 (2.8) | 25.6 (2.7) | 29.6 (7.7) | 29.3 (6.4) | 32.0 (8.2) | 32.2 (7.6) | 34.0 (3.1) | 35.3 (5.4) |
White, n (%) | 48 (94.1) | 64 (84.2) | 127 (90.7) | 200 (90.5) | 110 (90.2) | 216 (91.5) | 23 (88.5) | 52 (91.2) |
Duration of disease, years | 17.4 (10.6) | 18.7 (13.2) | 18.0 (12.0) | 18.5 (11.8) | 16.9 (12.0) | 19.0 (12.6) | 15.2 (11.7) | 17.6 (11.1) |
BSA, % | 26.5 (14.2) | 29.8 (18.9) | 27.6 (16.0) | 27.1 (18.6) | 27.3 (17.4) | 27.7 (18.8) | 23.6 (15.6) | 25.9 (17.7) |
PASI score | 20.7 (8.4) | 20.2 (8.3) | 20.2 (7.2) | 20.0 (8.3) | 20.8 (8.5) | 20.0 (8.5) | 19.2 (7.3) | 20.1 (8.2) |
DLQI score | 16.2 (6.5) | 15.8 (7.1) | 14.4 (7.3) | 14.6 (7.5) | 14.9 (7.7) | 14.7 (7.1) | 13.8 (6.4) | 15.6 (7.4) |
NAPSI score | 8.4 (3.3) | 7.9 (3.3) | 9.4 (3.2) | 9.9 (3.4) | 9.5 (4.3) | 9.9 (3.6) | 9.7 (2.9) | 11.4 (3.8) |
sPGA score | 3.4 (0.6) | 3.5 (0.6) | 3.4 (0.6) | 3.5 (0.6) | 3.6 (0.6) | 3.5 (0.6) | 3.6 (0.6) | 3.6 (0.6) |
PSI score | 19.6 (7.2) | 18.6 (7.1) | 18.4 (6.9) | 18.4 (7.1) | 19.6 (7.4) | 18.5 (6.7) | 18.8 (5.6) | 20.5 (6.3) |
Lifestyle Risk Factors
Lifestyle risk factor, n (%) | Brodalumab (n = 339) | Ustekinumab (n = 590) |
---|---|---|
None | 51 (15.0) | 76 (12.9) |
1 | 140 (41.3) | 221 (37.5) |
2 | 122 (36.0) | 236 (40.0) |
3 | 26 (7.7) | 57 (9.7) |
Brodalumab (n = 339) | Ustekinumab (n = 590) | |||
---|---|---|---|---|
Yes | No | Yes | No | |
Alcohol (current or stopped within last year) | 201 (59.3) | 138 (40.7) | 383 (64.9) | 207 (35.1) |
Smoking (current or stopped within last year) | 111 (32.7) | 228 (67.3) | 209 (35.4) | 381 (64.6) |
Obesity (BMI ≥ 30 kg/m2) | 147 (43.4) | 192 (56.6) | 271 (45.9) | 319 (54.1) |
Weight > 100 kg | 93 (27.4) | 246 (72.6) | 166 (28.1) | 424 (71.9) |
Responder Analysis for Complete Clearance (PASI100), PSI ≤ 8, and DLQI 0/1 by Number of Lifestyle Risk Factors
No risk factors | One risk factor | Two risk factors | Three risk factors | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Brodalumab (n = 51) | Ustekinumab (n = 76) | OR (95% CI) | Brodalumab (n = 140) | Ustekinumab (n = 221) | OR (95% CI) | Brodalumab (n = 122) | Ustekinumab (n = 236) | OR (95% CI) | Brodalumab (n = 26) | Ustekinumab (n = 57) | OR (95% CI) | |
PASI100 week 12 | 24 (47.1) | 16 (21.1) | 3.54 (1.41–8.87)** | 51 (36.4) | 44 (19.9) | 2.54 (1.52–4.25)*** | 56 (45.9) | 49 (20.8) | 3.59 (2.09–6.17)*** | 10 (38.5) | 12 (21.1) | 1.53 (0.45–5.22) |
PASI100 week 52 | 29 (56.9) | 26 (34.2) | 2.50 (1.14–5.46)* | 77 (55.0) | 49 (22.2) | 4.64 (2.80–7.69)*** | 56 (45.9) | 76 (32.2) | 2.06 (1.25–3.40)** | 11 (42.3) | 15 (26.3) | 2.55 (0.55–11.91) |
PSI response week 12 | 37 (72.5) | 47 (61.8) | 2.11 (0.80–5.53) | 89 (63.6) | 117 (52.9) | 1.57 (0.95–2.60) | 76 (62.3) | 134 (56.8) | 1.11 (0.66–1.88) | 20 (76.9) | 30 (52.6) | 2.37 (0.62–9.03) |
PSI response week 52 | 23 (45.1) | 36 (47.4) | 1.09 (0.48–2.43) | 70 (50.0) | 69 (31.2) | 2.56 (1.55–4.22)*** | 57 (46.7) | 100 (42.4) | 1.45 (0.86–2.45) | 10 (38.5) | 23 (40.4) | 1.03 (0.28–3.85) |
DLQI 0/1 week 12 | 30 (58.8) | 36 (47.4) | 1.75 (0.75–4.10) | 84 (60.0) | 89 (40.3) | 2.20 (1.37–3.54)*** | 69 (56.6) | 120 (50.8) | 1.14 (0.71–1.81) | 20 (76.9) | 24 (42.1) | 3.54 (0.84–14.92) |
DLQI 0/1 week 52 | 32 (62.7) | 36 (47.4) | 1.72 (0.78–3.79) | 76 (54.3) | 73 (33.0) | 2.49 (1.54–4.02)*** | 67 (54.9) | 108 (45.8) | 1.57 (0.97–2.54) | 11 (42.3) | 18 (31.6) | 2.07 (0.45–9.57) |