Main efficacy and safety outcomes for the new drugs for the treatment of PsA, at time point of the trial's primary end point
| Trial, time point | Treatment arm | ACR20 (%) (NNT) | ACR50 (%) (NNT) | PASI75 (%) (NNT) | Delta HAQ mean (95%CI or SD) | Delta mSvdH mean (SD) | Withdrawals due to AEs (%) |
|---|---|---|---|---|---|---|---|
| PSUMMIT 1 24W1 | UST 90 mg (N=204) | 49.5 (3.7) | 27.9 (5.2) | 62.4 (1.9) | −0.25 (−0.75 to 0.00) | 0.4 (2.4)* | 1.5 |
| UST 45 mg (N=205) | 42.4 (5.1) | 24.9 (6.2) | 57.2 (2.2) | −0.25 (−0.63 to 0.00) | 0.4 (2.1)* | 1.5 | |
| PBO (N=206) | 22.8 | 8.7 | 11.0 | 0.00 (−0.38 to 0.00) | 1.0 (3.9)* | 3.4 | |
| PSUMMIT 2 24W2 34 | UST 90 mg (N=105) | 43.8 (4.2) | 22.9 (6.2) | 55.6 (2.0) | −0.25 (−0.50 to 0.00) | † | 2.9 |
| UST 45 mg (N=103) | 43.7 (4.3) | 17.5 (9.3) | 51.3 (2.2) | −0.13 (−0.38 to 0.00) | † | 1.9 | |
| PBO (N=104) | 20.2 | 6.7 | 5.0 | 0.00 (−0.13 to 0.13) | † | 10.6 | |
| PALACE 1 16W3 | APR30 mg (N=168) | 38.1 (5.2) | NA | NA | −0.24 (0.04) | NA | NA |
| APR20 mg (N=168) | 30.4 (8.8) | NA | NA | −0.20 (0.04) | NA | NA | |
| PBO (N=168) | 19.0 | NA | NA | −0.09 (0.04) | NA | NA | |
| PALACE 2 16W38 | APR30 mg (N=162) | 34.4 (6.7) | NA | NA | NA | NA | NA |
| APR20 mg (N=163) | 38.4 (5.3) | NA | NA | NA | NA | NA | |
| PBO (N=159) | 19.5 | NA | NA | NA | NA | NA | |
| PALACE 3 16W39 | APR30 mg (N=159) | 42.8 (4.2) | NA | NA | NA | NA | NA |
| APR20 mg (N=163) | 29.4 (9.5) | NA | NA | NA | NA | NA | |
| PBO (N=164) | 18.9 | NA | NA | NA | NA | NA | |
| PALACE 4 16W40–43 | APR30 mg (N=175) | 32.3 (6.5) | NA | NA | NA | NA | NA |
| APR20 mg (N=175) | 29.2 (8.1) | NA | NA | NA | NA | NA | |
| PBO (N=176) | 16.9 | NA | NA | NA | NA | NA | |
| FUTURE 1 24 W5 | SEC 150 mg (N=202) | 50.0 (3.1) | 34.7 (3.7) | 61.1 (1.9) | −0.40 (0.04) | 0.13 (0.09) | 1.5 |
| SEC 75 mg (N=202) | 50.5 (3.0) | 30.7 (4.3) | 64.8 (1.8) | −0.41 (0.04) | 0.02 (0.12) | 2.0 | |
| PBO (N=202) | 17.3 | 7.4 | 8.3 | −0.17 (0.05) | 0.57 (0.19) | 2.5 | |
| FUTURE 2 24 W4 | SEC 300 mg (N=100) | 54.0 (2.6) | 35.0 (3.6) | 63.0 (2.1) | −0.56 (0.05) | NA | 2.0 |
| SEC 150 mg (N=100) | 51.0 (2.8) | 35.0 (3.6) | 48.0 (3.1) | −0.48 (0.05) | NA | 0.0 | |
| SEC 75 mg (N=99) | 29.0 (7.1) | 18.0 (9.0) | 28.0 (7.9) | −0.32 (0.05) | NA | 2.0 | |
| PBO (N=98) | 15.0 | 7.0 | 16.0 | −0.31 (0.06) | NA | 3.0 |
*Results reflect a pooled analysis of PSUMMIT 1 and 2, as a priori predefined.
†See results for PSUMMIT 1 which reflect a pooled analysis of PSUMMIT 1 and 2, as a priori predefined.
ACR20: American College of Rheumatology 20% improvement; AE, adverse event; APR, apremilast; HAQ, health assessment questionnaire; mSvDH, modified Sharp-van der Heijde score; NA, not available; NNT, number needed to treat; PALACE, psoriatic arthritis long-term assessment of clinical efficacy; PASI, psoriatic arthritis skin index; PBO, placebo; SEC, secukinumab; UST, ustekinumab.