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. 2019 Jul 3;9(3):553–569. doi: 10.1007/s13555-019-0310-5

Table 1.

Trial list and patient demographics

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