Table 2. Secondary Efficacy End Points.
| Secondary efficacy end points | DERMIS-1 trial | DERMIS-2 trial | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Roflumilast (n = 286) | Vehicle (n = 153) | Difference (95% CI) | Odds ratio (95% CI) | P value | Roflumilast (n = 290) | Vehicle (n = 152) | Difference (95% CI) | Odds ratio (95% CI) | P value | |
| I-IGA success at wk 8, % of patients (95% CI)a | 71.2 (58 to 82) | 13.8 (5 to 31) | 66.5 (47.1 to 85.8) | 17.94 (2.33-138.20) | <.001 | 68.1 (54 to 80) | 18.5 (8 to 37) | 51.6 (29.3 to 73.8) | 11.18 (2.33-53.68) | <.001 |
| No. | 52 | 29 | 47 | 27 | ||||||
| I-IGA status of clear at wk 8, % of patients (95% CI)b | 63.5 (50 to 75) | 10.3 (4 to 26) | 58.1 (39.3 to 76.9) | 29.36 (2.99-288.36) | <.001 | 57.4 (43 to 70) | 7.4 (2 to 23) | 52.2 (32.1 to 72.2) | 15.27 (3.10-75.35) | <.001 |
| No. | 52 | 29 | 47 | 27 | ||||||
| Achievement of 75% reduction in PASI score at wk 8, % of patients (95% CI)c | 41.6 (36 to 48) | 7.6 (4 to 13) | 36.1 (28.5 to 43.8) | 12.00 (5.15-27.93) | <.001 | 39.0 (33 to 45) | 5.3 (3 to 11) | 32.4 (24.9 to 39.8) | 10.42 (4.49-24.19) | <.001 |
| No. | 255 | 132 | 264 | 131 | ||||||
| WI-NRS success at wk 2, % of patients (95% CI)d | 34.9 (29 to 42) | 22.0 (15 to 31) | 10.8 (0.1 to 21.5) | 1.76 (0.98-3.19) | .12 | 41.9 (35 to 49) | 21.1 (14 to 30) | 18.9 (8.3 to 29.5) | 2.56 (1.43-4.58) | .003 |
| No. | 209 | 109 | 215 | 109 | ||||||
| WI-NRS success at wk 4, % of patients (95% CI)d | 50.2 (43 to 57) | 18.0 (12 to 27) | 30.7 (19.6 to 41.7) | 4.36 (2.31-8.26) | <.001 | 56.6 (50 to 63) | 21.9 (15 to 31) | 32.9 (22.3 to 43.4) | 4.93 (2.65-9.18) | <.001 |
| No. | 201 | 100 | 212 | 105 | ||||||
| WI-NRS success at wk 8, % of patients (95% CI)d | 67.5 (61 to 74) | 26.8 (19 to 36) | 42.6 (31.3 to 53.8) | 7.84 (3.85-15.94) | <.001 | 69.4 (63 to 75) | 35.6 (27 to 45) | 30.2 (18.2 to 42.2) | 3.59 (2.07-6.23) | <.001 |
| No. | 191 | 97 | 206 | 101 | ||||||
| Change from baseline PSD score at wk 4, least-squares mean (95% CI)e | −43.5 (−48.2 to −38.9) | −17.7 (−23.5 to −11.9) | −25.8 (−31.7 to −20.0) | <.001 | −42.7 (−47.7 to −37.7) | −16.7 (−22.8 to −10.6) | −26.0 (−31.9 to −20.0) | <.001 | ||
| No. | 261 | 130 | 262 | 135 | ||||||
| Change from baseline PSD score at wk 8, least-squares mean (95% CI)e | −50.1 (−55.0 to −45.1) | −19.2 (−25.3 to −13.0) | −30.9 (−37.2 to −24.6) | <.001 | −49.3 (−54.8 to −43.7) | −22.8 (−29.6 to −16.0) | −26.5 (−33.2 to −19.7) | <.001 | ||
| No. | 250 | 129 | 257 | 127 | ||||||
| Kaplan-Meier estimate of time to achievement of 50% reduction in PASI score, median (95% CI), dc | 31.0 (29.0 to 41.0) | 104.0 (85.0 to NE) | 3.867 (2.795-5.351)f | <.001 | 30.0 (29.0 to 42.0) | NE (71.0 to NE) | 4.207 (3.029-5.844)f | <.001 | ||
Abbreviations: I-IGA, intertriginous Investigator Global Assessment; NE, not estimable; PASI, Psoriasis Area and Severity Index; PSD, Psoriasis Symptom Diary; WI-NRS, Worst Itch Numeric Rating Scale.
I-IGA success indicates an I-IGA status of clear or almost clear plus ≥2-grade improvement from baseline assessed on a 5-point scale with scores ranging from 0 (clear) to 4 (severe). Conducted for patients with intertriginous area involvement of at least mild severity (I-IGA score ≥2), evaluating intertriginous areas only and not whole-body involvement.
Assessed on a 5-point scale ranging from 0 (clear) to 4 (severe). Conducted for patients with intertriginous area involvement of at least mild severity (I-IGA score ≥2) at baseline, evaluating intertriginous areas only and not whole-body involvement.
The PASI combines assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease).8
The WI-NRS is a single item to assess patient-reported severity of this symptom at its highest intensity during the previous 24-hour period on a scale from 0 (no itch) to 10 (worst imaginable itch).9 WI-NRS success indicates a ≥4-point reduction on the WI-NRS in patients with a WI-NRS score of ≥4 at baseline.
Patients used the PSD to determine the severity and impact of psoriasis-related signs and symptoms over the past 24 hours. Patients rated each variable in the 16-item assessment on a scale from 0 to 10, with the total score ranging from 0 to 160 and higher scores indicating greater severity or burden. The PSD end point was analyzed using analysis of covariance and performed using both multiple imputation and observed data. The values reported are the observed data, while the least-squares means and differences used multiple imputation for missing values.10 See eTable 3 in Supplement 5 for additional details.
Data are hazard ratios with 95% CIs.