Table 1.
Trial agent | Efalizumab [13] | Alefacept [14] | Etanercept [15] | Etanercept [16] | Tofacitinib [20] | Tofacitinib [21] |
---|---|---|---|---|---|---|
NCT number | NCT00602823 | NCT00422617 | NCT00245960 | NCT00663052 | NCT01276639 | NCT01815424 |
Mode of action | CD11a | Fusion CD2/T cell |
Fusion/receptor TNF |
Fusion/receptor TNF |
JAK | JAK |
Acronym | PRESTA | PRISTINE | ||||
Definition of moderate-to-severe psoriasis | PASI ≥ 12 and BSA ≥ 10% | PASI ≥ 12 and BSA ≥ 10% | GA score ≥ 3 and BSA ≥ 10% | PASI ≥ 10 and BSA ≥ 10% | PASI ≥ 12, PGA score ≥ 3, and BSA ≥ 10% | PASI ≥ 12, PGA score ≥ 3, and BSA ≥ 10% |
Intervention | Efalizumab 1 mg/kg once QW | Alefacept 15 mg QW | Etanercept 50 mg BIW or QW for 12 weeks, then QW for 12 weeks | Etanercept 50 mg BIW or QW for 12 weeks, then QW for 12 weeks | Tofacitinib 5 or 10 mg or placebo BIW. Placebo arm was re-randomized to receive tofacitinib 5 or 10 mg BID at week 16 | Tofacitinib 5 or 10 mg or placebo BIW. Placebo arm was re-randomized to receive tofacitinib 5 or 10 mg BID at week 16 |
Duration of treatment | 12 weeks, with 12-week treatment-free follow-up | 12 weeks, with 12-week treatment-free follow-up | 12-week double-blind period and 12-week open-label period, with 2-week follow-up | 12-week double-blind period and 12-week open-label period, with 2-week follow-up | 52 weeks and open-label extension up to 5 years | 52 weeks |
Age, mean ± SD | 56.2 ± 12.2 | 50.6 ± 13.3 | 50.7 ± 15.2 | 45.9 ± 9.3 | 43.3 ± 12.2 | 40.5 ± 12.2 |
Weight (kg), mean ± SD | 70.7 ± 12.7 | 74.6 ± 13.2 | 73.7 ± 19.7 | 74.6 ± 11.7 | 77.7 ± 16.6 | 70.6 ± 14.4 |
Duration since diagnosis (years), mean ± SD | 2.5 ± 2.8 | 2.0 ± 2.1 | 1.6 ± 2.3 | 2.8 ± 2.1 | 5.6 ± 2.9 | 3.8 ± 2.8 |
Biologic naive, n (%) | 25 (100.0%) | 8 (57.1%) | 11 (73.3%) | 14 (87.5%) | 14 (54.8%) | 12 (85.7%) |
Baseline PASI, mean ± SD | 27.2 ± 12.6 | 19.9 ± 11.4 | 23.6 ± 12.8 | 23.6 ± 8.1 | 21.1 ± 9.1 | 26.2 ± 12.9 |
Trial agent | Ixekizumab [22] | Secukinumab [18] | Secukinumab and ustekinumab [19] | Ustekinumab [17] | Ustekinumab and guselkumab [23] | Pooled |
---|---|---|---|---|---|---|
NCT number | NCT02513550 | NCT01365455, NCT01544595 | NCT02074982 | NCT00747344 | NCT02203032 | |
Mode of action | IL17 | IL17 | Secukinumab: IL17; ustekinumab: IL12/IL23 | IL12/IL23 | Ustekinumab: IL12/IL23; guselkumab: IL23 | |
Acronym | IXORA-P | ERASURE | CLEAR | PEARL | NAVIGATE | |
Definition of moderate-to-severe psoriasis | PASI ≥ 12 and PGA score ≥ 3 | PASI ≥ 12, PGA score ≥ 3, and BSA ≥ 10% | PASI ≥ 12, PGA score ≥ 3, and BSA ≥ 10% | PASI ≥ 12 and BSA ≥ 10% | PASI ≥ 12, PGA score ≥ 3, and BSA ≥ 10% | |
Intervention | Ixekizumab 80 mg Q2W or Q4W | Secukinumab 300 mg or 150 mg QW for 4 weeks, then monthly until week 48 | Secukinumab 300 mg QW for 4 weeks, then Q4W until week 48. Ustekinumab 45 or 90 mg at week 0, 4, 16, 28, 40 | Ustekinumab 45 mg at weeks 0, 4, 16 or placebo at weeks 0, 4 and ustekinumab 45 mg at weeks 12, 16 | Ustekinumab 45 or 90 mg at weeks 0, 4. Guselkumab 100 mg at weeks 16, 20, 28, 36, 44 or ustekinumab 45 or 90 mg at weeks 16, 28, 40 | |
Duration of treatment | 52 weeks | 12-week induction period and 40-week maintenance period, with 8-week follow-up | 2 years for secukinumab arm and 1 year for ustekinumab arm | 12-week placebo-controlled period, with follow-up until week 36 | 16-week open-label period and 28-week randomized period, with 16-week follow-up | |
Age, mean ± SD | 47.4 ± 10.4 | 27.4 ± 12.1 | 48.7 ± 17.1 | 53.0 ± 12.4 | 43.4 ± 12.2 | 48.6 ± 13.3 |
Weight (kg), mean ± SD | 93.9 ± 20.8 | 80.2 ± 17.0 | 72.5 ± 16.5 | 77.3 ± 14.7 | 75.6 ± 12.4 | 76.6 ± 16.6 |
Duration since diagnosis (years), mean ± SD | 4.7 ± 4.0 | 6.9 ± 3.8 | 5.0 ± 2.4 | 2.8 ± 2.6 | 4.9 ± 3.2 | 4.1 ± 3.3 |
Biologic naive, n (%) | 10 (66.7%) | 21 (61.8%) | 14 (58.3%) | 22 (73.3%) | 6 (42.9%) | 160 (69.0%) |
Baseline PASI, mean ± SD | 24.8 ± 11.4 | 23.1 ± 8.5 | 20.9 ± 8.3 | 23.9 ± 10.2 | 23.3 ± 11.1 | 23.3 ± 10.3 |
Clinical demographics of the trials that are included in this study and pooled data are arranged by mode of action. Key inclusion criteria, intervention agent, and duration of each trial were provided
NCT number clinicaltrials.gov identifier, PASI psoriasis area and severity index, TNF tumor necrosis factor, JAK Janus kinase