Table II.
Risankizumab effectiveness in relation to sex, age, body mass index (BMI), previous exposure to biologics, Psoriasis Area and Severity Index (PASI) at baseline, and cardiometabolic comorbidities
| Characteristics | OR (95% CI) | p-value | ||
|---|---|---|---|---|
| Week 16 | ΔPASI <75% | ΔPASI ≥75% | ||
| n = 77 | 11 | 66 | ||
| Sex, male, n (%) | 7 (63.6) | 51 (77.3) | 1.94 (0.50–7.54) | 0.337 |
| Age, years, mean ± SD | 55.1 ± 15.0 | 42.0 ± 14.9 | 0.94 (0.90–0.99) | 0.018 |
| BMI, kg/m2, median (IQR) | 30.4 (20.1–46.3) | 27.1 (19.8–39.2) | 0.87 (0.75–1.01) | 0.066 |
| Cardiometabolic comorbidities, n (%) | 7 (63.6%) | 35 (53.0%) | 0.65 (0.17–2.42) | 0.515 |
| Previous biological therapy, n (%) | ||||
| Bio-naïve | 5 (45.5) | 42 (63.6) | 1 | |
| 1 previous biologic | 1 (9.1) | 14 (21.2) | 1.66 (0.18–15.51) | 0.654 |
| ≥2 previous biologics | 5 (45.5) | 10 (15.2) | 0.24 (0.06–0.98) | 0.047* |
| Baseline PASI | 15 (8–16) | 16 (5–36) | 1.13 (0.98–1.31) | 0.093 |
| Baseline PASI (≥20) | 0 | 18 (27.3%) | – | |
| Week-16 | ΔPASI <90% | ΔPASI ≥90% | ||
| n = 77 | 30 | 47 | ||
| Sex, male, n (%) | 23 (76.7) | 35 (74.5) | 0.89 (0.30–2.59) | 0.827 |
| Age, years, mean ± SD | 46.2 ± 16.9 | 43.0 ± 14.7 | 0.99 (0.95–1.02) | 0.427 |
| BMI, kg/m2, median (IQR) | 28.1 (19.8–46.3) | 27.5 (20.0–39.2) | 0.97 (0.87–1.09) | 0.611 |
| Cardiometabolic comorbidities, n (%) | 20 (66.7) | 22 (46.8) | 0.44 (0.17–1.14) | 0.091 |
| Previous biological therapy, n (%) | ||||
| Bio-naïve | 14 (46.7) | 33 (79.2) | 1 | |
| 1 previous biologic | 7 (23.3) | 8 (17.0) | 0.48 (0.15–1.60) | 0.234 |
| ≥ 2 previous biologics | 9 (30.0) | 6 (12.8) | 0.28 (0.08–0.95) | 0.040* |
| Baseline PASI | 15 (8–27) | 16 (5–36) | 1.05 (0.97–1.14) | 0.211 |
| Baseline PASI (≥ 20) | 5 (16.7) | 13 (27.7) | 1.85 (0.62–5.54) | 0.271 |
| Week 16 | ΔPASI <100% | ΔPASI ≥100% | ||
| n = 77 | 55 | 22 | ||
| Sex, male, n (%) | 41 (74.6) | 17 (77.3) | 1.16 (0.36–3.73) | 0.802 |
| Age, years, mean ± SD | 45.2 ± 16.0 | 42.3 ± 15.0 | 0.99 (0.95–1.02) | 0.512 |
| BMI, kg/m2, median (IQR) | 28.4 (19.8–46.3) | 27.0 (20.0–36.0) | 0.95 (0.83–1.08) | 0.425 |
| Cardiometabolic comorbidities, n (%) | 33 (60.0) | 9 (40.9) | 0.46 (0.17–1.26) | 0.132 |
| Previous biological therapy, n (%) | ||||
| Bio-naïve | 33 (60.0) | 14 (63.6) | 1 | |
| 1 previous biologic | 10 (18.2) | 5 (22.7) | 1.18 (0.34–4.08) | 0.795 |
| ≥2 previous biologics | 12 (21.8) | 3 (13.6) | 0.59 (0.14–2.41) | 0.463 |
| Baseline PASI | 16 (5–36) | 15.5 (10–28) | 0.98 (0.91–1.06) | 0.669 |
| Baseline PASI (≥20) | 14 (25.5) | 4 (18.2) | 0.66 (0.20–2.16) | 0.498 |
| Week 40 | ΔPASI <75% | ΔPASI ≥75% | ||
| n = 77 | 1 | 76 | ||
| Week 40 | ΔPASI <90% | ΔPASI ≥90% | ||
| n = 77 | 11 | 66 | ||
| Sex, male, n (%) | 7 (63.4) | 51 (77.3) | 1.94 (0.50–7.54) | 0.337 |
| Age, years, mean ± SD | 53.9 ± 13.7 | 43.0 ± 15.5 | 0.96 (0.91–1.00) | 0.076 |
| BMI, kg/m2, median (IQR) | 32.0 (20.1–46.3) | 27.1 (19.8–36.8) | 0.82 (0.68–0.98) | 0.029* |
| Cardiometabolic comorbidities, n (%) | 8 (72.7) | 34 (51.5) | 0.40 (0.10–1.64) | 0.201 |
| Previous biological therapy, n (%) | ||||
| Bio-naïve | 3 (27.3) | 44 (66.7) | 1 | |
| 1 previous biologic | 1 (9.1) | 14 (21.2) | 0.95 (0.09–9.93) | 0.969 |
| ≥ 2 previous biologics | 7 (63.6) | 8 (12.1) | 0.08 (0.02–0.36) | 0.001* |
| Baseline PASI | 15 (12–36) | 16 (5–35) | 0.99 (0.90–1.09) | 0.824 |
| Baseline PASI (≥20) | 2 (18.2) | 16 (24.2) | 1.41 (0.30–6.67) | 0.662 |
| Week 40 | ΔPASI <100% | ΔPASI ≥100% | ||
| n=77 | 29 | 48 | ||
| Sex, male, n (%) | 23 (79.3) | 35 (72.9) | 0.70 (0.23–2.11) | 0.529 |
| Age, years, mean ± SD | 46.3 ± 15.6 | 43.2 ± 15.7 | 0.99 (0.95–1.02) | 0.455 |
| BMI, kg/m2, median (IQR) | 28.8 (19.8–46.3) | 27.0 (20.0–36.8) | 0.93 (0.82–1.05) | 0.228 |
| Cardiometabolic comorbidities, n (%) | 20 (69.0) | 22 (45.8) | 0.38 (0.14–1.00) | 0.051 |
| Previous biological therapy, n (%) | ||||
| Bio-naïve | 14 (48.3) | 33 (68.8) | 1 | |
| 1 previous biologic | 5 (17.2) | 10 (20.8) | 0.85 (0.24–2.94) | 0.795 |
| ≥2 previous biologics | 10 (34.5) | 5 (10.4) | 0.21 (0.06–0.73) | 0.014* |
| Baseline PASI | 16 (5–36) | 15 (6–35) | 0.96 (0.89–1.03) | 0.269 |
| Baseline PASI (≥20) | 8 (27.6%) | 10 (20.8%) | 1.81 (1.06–3.08) | 0.029* |
ΔPASI ≥75%: PASI 75; ΔPASI ≥90%: PASI 90; ΔPASI ≥100%: PASI 100; SD: standard deviation; IQR: interquartile range.