This phase III trial was designed to compare a candidate ustekinumab biosimilar, CT-P43, to originator ustekinumab in adults with moderate to severe plaque psoriasis. |
CT-P43 showed equivalent efficacy to originator ustekinumab, with comparable pharmacokinetics, safety and immunogenicity. |
1 Introduction
2 Methods
2.1 Study Design
2.2 Patients
2.3 Study Endpoints and Assessments
2.4 Statistical Analysis
3 Results
3.1 Patient Disposition
CT-P43 (N = 256) | Originator ustekinumab (N = 253) | |
---|---|---|
Baseline patient demographics and disease characteristics | ||
Age (years), median (range) | 41.0 (18–74) | 41.0 (18–77) |
Sex, n (%) | ||
Male | 161 (62.9) | 173 (68.4) |
Female | 95 (37.1) | 80 (31.6) |
Race, n (%) | ||
Asian | 25 (9.8) | 23 (9.1) |
White | 231 (90.2) | 230 (90.9) |
Ethnicity, n (%) | ||
Hispanic or Latino | 1 (0.4) | 1 (0.4) |
Non-Hispanic or Non-Latino | 255 (99.6) | 252 (99.6) |
Height (cm) at screening, median (range) | 173.95 (151.7–213.0) | 174.00 (141.0–195.0) |
Body weight (kg), median (range) | 84.25 (41.0–168.0) | 86.00 (46.1–151.5) |
Body mass index (kg/m2), median (range) | 27.515 (15.82–46.54) | 27.920 (15.85–48.36) |
Involved body surface area (%), mean (SD) | 26.1 (14.2) | 24.3 (13.2) |
Time since plaque-type psoriasis diagnosis (years), mean (SD) | 17.81 (12.144) | 15.56 (11.560) |
Concomitant PsA, n (%) | 80 (31.3) | 83 (32.8) |
PASI score, mean (SD) | 21.51 (7.939) | 20.88 (7.998) |
DLQI score, mean (SD) | 13.2 (7.08) | 11.9 (6.68) |
sPGA score, mean (SD) | 3.2 (0.37) | 3.2 (0.38) |
Prior use of non-biologic systemic agents, n (%) | 155 (60.5) | 146 (57.7) |
Prior use of systemic steroids, n (%) | 27 (10.5) | 20 (7.9) |
Stratification factors (first randomisation) | ||
Country, n (%) | ||
Estonia | 5 (2.0) | 6 (2.4) |
Poland | 189 (73.8) | 188 (74.3) |
Republic of Korea | 25 (9.8) | 23 (9.1) |
Ukraine | 37 (14.5) | 36 (14.2) |
Baseline body weight category, n (%) | ||
≤ 100 kg | 198 (77.3) | 199 (78.7) |
> 100 kg | 58 (22.7) | 54 (21.3) |
Use of prior biologic approved for psoriasis treatment, n (%) | ||
Yes | 38 (14.8) | 44 (17.4) |
No | 218 (85.2) | 209 (82.6) |
3.2 Efficacy
Analysis protocol | Treatment group | n | LS mean (SE) | Estimate (CI) of treatment difference (%) |
---|---|---|---|---|
FDAa | mITT set | 90% CI | ||
CT-P43 | 256 | 77.93 (1.771) | 2.05 (−0.23, 4.32) | |
Originator ustekinumab | 253 | 75.89 (1.739) | ||
PP set | 90% CI | |||
CT-P43 | 252 | 78.06 (1.767) | 2.00 (−0.29, 4.29) | |
Originator ustekinumab | 244 | 76.06 (1.735) | ||
EMAb | FAS | 95% CI | ||
CT-P43 | 198 | 78.26 (2.054) | 0.94 (−2.29, 4.16) | |
Originator ustekinumab | 194 | 77.33 (2.049) | ||
PP set | 95% CI | |||
CT-P43 | 195 | 78.41 (2.038) | 0.87 (−2.32, 4.07) | |
Originator ustekinumab | 193 | 77.54 (2.025) |
Week 12 | Week 28 | ||||
---|---|---|---|---|---|
CT-P43 (N = 256) | Originator ustekinumab (N = 253) | Continued CT-P43 (N = 253) | Continued originator ustekinumab (N = 125) | Switched to CT-P43 (N = 124) | |
Change from baseline in DLQI score | |||||
n | 255 | 248 | 250 | 124 | 124 |
Mean (SD) | −9.7 (6.74) | −8.5 (6.67) | −10.9 (7.20) | −8.8 (6.95) | −9.4 (6.66) |
Median (range) | −9.0 (−28 to 7) | −7.0 (−29 to 7) | −10.0 (−27 to 14) | −8.0 (−28 to 8) | −8.5 (−29 to 2) |
3.3 Pharmacokinetics
3.4 Safety
CT-P43 (N = 256) | Originator ustekinumab (N = 253) | |
---|---|---|
Total number of TEAEs | 158 | 110 |
Patients with ≥ 1 TEAE, n (%) | 95 (37.1) | 75 (29.6) |
Related to study drug | 18 (7.0) | 15 (5.9) |
Total number of TESAEs | 4 | 4 |
Patients with ≥ 1 TESAE, n (%) | 4 (1.6) | 4 (1.6) |
Related to study drug | 1 (0.4) | 0 |
Total number of TEAEs leading to study drug discontinuation | 0 | 0 |
Total number of TEAEs classified as infection | 39 | 35 |
Patients with ≥ 1 TEAE classified as infection, n (%) | 34 (13.3) | 32 (12.6) |
Related to study drug | 9 (3.5) | 8 (3.2) |
Total number of TEAEs classified as ISR | 3 | 2 |
Patients with ≥ 1 TEAE classified as ISR, n (%) | 3 (1.2) | 2 (0.8) |
Related to study drug | 3 (1.2) | 2 (0.8) |
Total number of TEAEs classified as hypersensitivity reaction | 0 | 0 |
Total number of TEAEs classified as malignancy | 0 | 0 |
Total number of TEAEs leading to death | 0 | 0 |
Continued CT‑P43 (N = 253) | Continued originator ustekinumab (N = 125) | Switched to CT-P43 (N = 124) | |
---|---|---|---|
Total number of TEAEs | 57 | 38 | 40 |
Patients with ≥ 1 TEAE, n (%) | 40 (15.8) | 28 (22.4) | 26 (21.0) |
Related to study drug | 4 (1.6) | 5 (4.0) | 6 (4.8) |
Total number of TESAEs | 0 | 0 | 0 |
Total number of TEAEs leading to study drug discontinuation | 2 | 1 | 0 |
Patients with ≥ 1 TEAE leading to study drug discontinuation, n (%) | 2 (0.8) | 1 (0.8) | 0 |
Related to study drug | 0 | 1 (0.8) | 0 |
Total number of TEAEs classified as infection | 14 | 7 | 8 |
Patients with ≥ 1 TEAE classified as infection, n (%) | 14 (5.5) | 7 (5.6) | 7 (5.6) |
Related to study drug | 1 (0.4) | 3 (2.4) | 1 (0.8) |
Total number of TEAEs classified as ISR | 1 | 0 | 2 |
Patients with ≥ 1 TEAE classified as ISR, n (%) | 1 (0.4) | 0 | 2 (1.6) |
Related to study drug | 0 | 0 | 2 (1.6) |
Total number of TEAEs classified as hypersensitivity reaction | 0 | 0 | 0 |
Total number of TEAEs classified as malignancy | 0 | 0 | 0 |
Total number of TEAEs leading to death | 0 | 0 | 0 |