Table 4.
Pivotal phase III trials of TNFi in psoriatic arthritis.
| Reference | Study size (n) |
Doses (vs. placebo) | % Achieving ACR20 response (tx/ placebo) (primary endpt wk) |
% Achieving PASI75 response (tx/placebo) (primary endpt wk) |
Inhibition of radiographic progression |
|
|---|---|---|---|---|---|---|
| Infliximab | IMPACT [97,98] | 104 | 5 mg/kg IV | 65.4/9.6 (16) | 68/0 (16) | 50 wks |
| IMPACT 2 [99,100] | 200 | 5 mg/kg IV | 58/11 (14) | 64/2 (14) | 6 months and 1 yr | |
| Etanercept | 12-wk study [101] | 60 | 25 mg SC 2x wk | 73/13 (12) | 26/0 (12) | Not studied |
| 24-wk study [94,102] | 205 | 25 mg SC 2x wk | 59/15 (12) | – | 12 months and 2 yrs | |
| Adalimumab | ADEPT [92] | 313 | 40 mg SC eow | 58/14 (12) | – | 24 wks |
| Golimumaba | GO-REVEAL [90,91] | 405 | 50 mg/100 mg | 51/45/9 (14) | 40/58/3 (14) | 24 wks and 256 wks |
| Certolizumabb | RAPID-PsA [93,96] | 409 | 200 mg/400 mg | 58/51.9/24.3 (12) | 46.7/47.4/14 (12) | 96 wks |
ACR20: American College of Rheumatology 20% improvement criteria; endpt: end point; eow: every other week; IV: intravenous; PASI75: ≥75% improvement in Psoriasis Area and Severity Index; SC: subcutaneous; tx: treatment; TNFi: tumor necrosis factor inhibitor; wk: week; yrs: years.
a
SC dosing every 4 weeks.
b
200 mg SC every 2 weeks; 400 mg SC every 4 weeks.