Table 3.
Drug class | Compound | Dactylitis measure | Efficacy at week 24 |
---|---|---|---|
TNFα inhibitor | Adalimumab [53] | Scale of 0–3 for each digit of hands and feet (exploratory endpoint) | Mean improvement in dactylitis from baseline Improvement with adalimumab greater than placebo; statistical significance was not reached (values not presented) |
Infliximab [54] | Presence/absence of dactylitis (endpoint not specified) | Percentage of patients with dactylitis Infliximab (12%), placebo (34%); p < 0.001 |
|
Golimumab [55] | Scale of 0–3 for each digit of hands and feet (exploratory endpoint) | Median percentage change from baseline Golimumab 50 mg (100%), golimumab 100 mg (100%), placebo (42%); p = 0.09 vs. placebo and p < 0.001 vs. placebo, respectively |
|
Golimumab (intravenous) [56] | Scale of 0–3 for each digit of hands and feet (secondary endpoint at week 14) | Mean change from baseline Golimumab 2 mg/kg (− 8.2), placebo (− 5.0); p < 0.001 |
|
Etanercept [57] | Scale of 0–3 for each digit of hands and feet (secondary endpoint) | Mean percentage change from baseline Etanercept 50 mg BIW/QW (84.5%), etanercept 50 mg QW/QW (84.8%) |
|
Certolizumab pegol [58] | LDI (secondary endpoint) | Mean change from baseline Certolizumab pegol 200 mg (− 40.7), certolizumab pegol 400 mg (− 53.5), placebo (− 22.0); p = 0.002 vs. placebo and p < 0.001 vs. placebo, respectively |
|
IL-12/23 inhibitor | Ustekinumab [102] | Scale of 0–3 for each digit of hands and feet (exploratory endpoint) | Median percentage change from baseline Ustekinumab 45 mg (approximately − 75%; p = 0.0003 vs. placebo) and ustekinumab 90 mg (approximately − 70%; p = 0.0003 vs. placebo) |
IL-23 inhibitor | Guselkumaba [103] | Scale of 0–3 for each digit of hands and feet (secondary endpoint) | Median percentage change from baseline Guselkumab (− 100%), placebo (− 33%); p < 0.001 vs. placebo |
IL-17A inhibitor | Ixekizumab [104] | LDI (secondary endpoint) | Percentage of patients who achieved complete resolution of dactylitis Ixekizumab Q4W (75%), ixekizumab Q2W (50%), placebo (21%); p = 0.002 vs. placebo and p = 0.06 vs. placebo, respectively |
Secukinumab [105] | Scale of 1 (presence) or 0 (absence) for each digit of hands and feet (secondary endpoint) | Percentage of patients who achieved complete resolution of dactylitis Secukinumab 300 mg (56.5%), secukinumab 150 mg (50.0%), placebo (14.8%); p = 0.0021 vs. placebo and p = 0.0056 vs. placebo, respectively |
|
Small-molecule PDE4 inhibitor | Apremilast [106] | Scale of 1 (presence) or 0 (absence) for each digit of hands and feet (secondary endpoint at week 16) | Percentage of patients achieving complete resolution of dactylitis Apremilast 20 mg (50.9%), apremilast 30 mg (47.7%), placebo (40.9%); statistical significance was not reached |
T-cell inhibitor | Abatacept [89] | LDI (prespecified exploratory endpoint) | Percentage of patients achieving complete resolution of dactylitis Abatacept (44.3%), placebo (34.0%); statistical significance was not reached |
Small-molecule JAK inhibitor | Tofacitinib [90] | Dactylitis severity score (secondary endpoint) | Mean change from baseline Tofacitinib 5 mg (− 6.0), tofacitinib 10 mg (− 6.0) |
Efficacy results are presented at week 24 for consistency, and studies with secondary endpoints at other timepoints are indicated in the ‘Dactylitis measure’ column. All agents are approved for PsA unless otherwise noted. The score range for the dactylitis severity score is 0–20. LDI is determined by the number of tender and swollen digits with a circumference ≥ 10% higher than the contralateral digit according to the LDI basic score
BIW twice weekly, IL interleukin, JAK Janus kinase, LDI Leeds Dactylitis Index, PDE4 phosphodiesterase-4, PsA psoriatic arthritis, QW once weekly, Q4W every 4 weeks, Q2W every 2 weeks, TNF tumor necrosis factor
aExperimental compound in PsA, approved for moderate-to-severe psoriasis