Significant improvements were seen in PPPASI, PGA, PPSI, pruritus, and pain with apremilast versus placebo at week 16, which were sustained through week 32. |
Adverse events were consistent with the known safety profile of apremilast. |
1 Introduction
2 Methods
2.1 Study Design
2.2 Key Inclusion Criteria
2.3 Key Exclusion Criteria
2.4 Study Endpoints
2.5 Statistical Analysis
3 Results
3.1 Patients
Placebo (n = 44) | Apremilast 30 mg BID (n = 46) | |
---|---|---|
Age, years | ||
N | 44 | 46 |
Mean (SD) | 54.7 (11.68) | 54.9 (11.30) |
Sex, n (%) | ||
Male | 11 (25.0) | 10 (21.7) |
Female | 33 (75.0) | 36 (78.3) |
BMI, kg/m2 | ||
N | 44 | 46 |
Mean (SD) | 25.33 (5.309) | 24.37 (3.732) |
Tobacco use, n (%) | ||
User | 38 (86.4) | 37 (80.4) |
Nonuser | 6 (13.6) | 9 (19.6) |
Duration of PPP, years | ||
N | 44 | 46 |
Mean (SD) | 7.53 (9.026) | 7.34 (8.627) |
PPPASI score categories at randomization, n (%) | ||
≤ 20 | 14 (31.8) | 16 (34.8) |
≥ 21 to ≤ 30 | 19 (43.2) | 18 (39.1) |
≥ 31 | 11 (25.0) | 12 (26.1) |
PPSI total score | ||
N | 44 | 46 |
Mean (SD) | 8.2 (1.5) | 8.3 (1.5) |
PGA, n (%) | ||
2 | 1 (2.3) | 3 (6.5) |
3 | 24 (54.5) | 16 (34.8) |
4 | 17 (38.6) | 21 (45.7) |
5 | 2 (4.5) | 6 (13.0) |
Pruritus VAS | ||
N | 42 | 46 |
Mean (SD) | 57.0 (27.8) | 50.3 (31.6) |
Pain VAS | ||
N | 42 | 46 |
Mean (SD) | 50.3 (30.0) | 45.4 (31.9) |
DLQI total score | ||
N | 43 | 46 |
Mean (SD) | 7.2 (4.7) | 7.5 (4.9) |
Focal infection status at randomization, n (%) | ||
Presence | 32 (72.7) | 32 (69.6) |
Absence | 12 (27.3) | 14 (30.4) |
3.2 Efficacy in Disease Severity Outcomes
3.3 Efficacy in Patient-Reported Outcomes
3.4 Safety
Patients, n (%) | Week 16 | Apremilast Total (Week 32) | ||||||
---|---|---|---|---|---|---|---|---|
Placebo (n = 44) | Apremilast 30 mg BID (n = 46) | Placebo/Apremilast 30 mg BID (N = 41, patient-years = 12.5) | Apremilast 30 mg BID/Apremilast 30 mg BID (N = 46, patient years = 27.8) | |||||
n (%) | EAIR/100 patient-years | n (%) | EAIR/100 patient-years | n (%) | EAIR/100 patient-years | n (%) | EAIR/100 patient-years | |
Any TEAE | 31 (70.5) | 434.7 | 38 (82.6) | 854.6 | 32 (78.0) | 557.1 | 41 (89.1) | 639.7 |
Any severe TEAE | 1 (2.3) | 7.8 | 0 | 0 | 1 (2.4) | 8.1 | 1 (2.2) | 3.6 |
Any serious TEAE | 0 | 0 | 0 | 0 | 1 (2.4) | 8.1 | 2 (4.3) | 7.3 |
Any TEAE leading to drug withdrawal | 3 (6.8) | 23.5 | 0 | 0 | 0 | 0 | 0 | 0 |
Any TEAE leading to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Most commonly reported TEAEs (≥ 5% of patients) | ||||||||
Diarrhea | 6 (13.6) | 51.3 | 12 (26.1) | 112.3 | 6 (14.6) | 54.4 | 13 (28.3) | 63.1 |
Abdominal discomfort | 1 (2.3) | 7.9 | 7 (15.2) | 56.3 | 5 (12.2) | 43.0 | 8 (17.4) | 33.8 |
Headache | 0 | 0 | 6 (13.0) | 45.9 | 4 (9.8) | 34.0 | 6 (13.0) | 24.1 |
Nausea | 2 (4.5) | 16.1 | 6 (13.0) | 48.4 | 3 (7.3) | 25.9 | 6 (13.0) | 24.8 |
Contact dermatitis | 1 (2.3) | 7.8 | 5 (10.9) | 37.3 | 1 (2.4) | 8.2 | 9 (19.6) | 35.3 |
Nasopharyngitis | 2 (4.5) | 16.1 | 5 (10.9) | 37.6 | 4 (9.8) | 32.9 | 6 (13.0) | 23.7 |
Soft feces | 2 (4.5) | 16.2 | 5 (10.9) | 39.4 | 3 (7.3) | 25.9 | 5 (10.9) | 20.1 |
Decreased appetite | 0 | 0 | 3 (6.5) | 22.0 | 1 (2.4) | 8.1 | 3 (6.5) | 11.4 |
Eczema | 5 (11.4) | 42.0 | 3 (6.5) | 22.3 | 3 (7.3) | 25.5 | 3 (6.5) | 11.5 |
Folliculitis | 4 (9.1) | 32.0 | 1 (2.2) | 7.1 | 3 (7.3) | 24.6 | 1 (2.2) | 3.6 |