Table 2.
Efficacy endpoints at week 16
| Endpoint | Placebo n=66 |
Deucravacitinib | |
| 6 mg once a day n=70 |
12 mg once a day n=67 |
||
| Primary endpoint | |||
| ACR-20 | |||
| Response rate, % (95% CI) | 31.8 (20.6 to 43.1) | 52.9 (41.2 to 64.6) | 62.7 (51.1 to 74.3) |
| Adjusted OR vs placebo (95% CI) | 2.4 (1.2 to 4.8) | 3.6 (1.8 to 7.4) | |
| P value | 0.0134* | 0.0004* | |
| Secondary endpoints | |||
| HAQ-DI | |||
| Adjusted mean change from baseline (95% CI) | −0.1 (−0.2 to 0.0) | −0.4 (−0.5 to −0.2) | −0.4 (−0.5 to −0.3) |
| Difference from placebo (95% CI) | −0.3 (−0.4 to −0.1) | −0.3 (−0.5 to −0.1) | |
| P value | 0.0020* | 0.0008* | |
| PASI-75 | |||
| Response rate, % (95% CI) | 20.4 (9.6 to 31.1) | 42.4 (29.8 to 55.0) | 59.6 (46.3 to 73.0) |
| Adjusted OR vs placebo (95% CI) | 2.9 (1.3 to 6.7) | 5.8 (2.4 to 13.8) | |
| P value | 0.0136* | <0.0001* | |
| SF-36 PCS | |||
| Adjusted mean change from baseline (95% CI) | 2.3 (0.4 to 4.2) | 5.6 (3.8 to 7.5) | 5.8 (3.9 to 7.7) |
| Difference from placebo (95% CI) | 3.3 (0.9 to 5.7) | 3.5 (1.1 to 5.9) | |
| P value | 0.0062* | 0.0042* | |
| Additional endpoints | |||
| ACR-50 | |||
| Response rate, % (95% CI) | 10.6 (3.2 to 18.0) | 24.3 (14.2 to 34.3) | 32.8 (21.6 to 44.1) |
| Adjusted OR vs placebo (95% CI) | 2.7 (1.1 to 7.1) | 4.2 (1.7 to 10.9) | |
| P value | 0.0326 | 0.0016 | |
| ACR-70 | |||
| Response rate, % (95% CI) | 1.5 (0.0 to 4.5) | 14.3 (6.1 to 22.5) | 19.4 (9.9 to 28.9) |
| Adjusted OR vs placebo (95% CI) | 12.0 (1.5 to 99.3) | 19.0 (2.3 to 155.2) | |
| P value | 0.0044 | 0.0003 | |
| HAQ-DI | |||
| Response rate†, % (95% CI) | 15.2 (6.5 to 23.8) | 38.6 (27.2 to 50.0) | 40.3 (28.6 to 52.0) |
| Adjusted OR vs placebo (95% CI) | 3.8 (1.6 to 8.8) | 3.7 (1.6 to 8.4) | |
| P value | 0.0019 | 0.0015 | |
| SF-36 MCS | |||
| Adjusted mean change from baseline (95% CI) | 0.7 (−1.3 to 2.7) | 3.6 (1.7 to 5.5) | 3.5 (1.5 to 5.5) |
| Adjusted mean difference from placebo (95% CI) | 2.9 (0.4 to 5.3) | 2.8 (0.3 to 5.3) | |
| P value | 0.0211 | 0.0263 | |
| Enthesitis resolution (LEI) | n=31 | n=39 | n=26 |
| Response rate, % (95% CI) | 22.6 (7.9 to 37.3) | 51.3 (35.6 to 67.0) | 50.0 (30.8 to 69.2) |
| Adjusted OR vs placebo (95% CI) | 3.6 (1.3 to 10.3) | 3.4 (1.1 to 10.7) | |
| P value | 0.0138 | 0.0393 | |
| Dactylitis resolution | n=25 | n=30 | n=24 |
| Response rate, % (95% CI) | 60.0 (40.8 to 79.2) | 76.7 (61.5 to 91.8) | 79.2 (62.9 to 95.4) |
| Adjusted OR vs placebo (95% CI) | 2.2 (0.7 to 7.1) | 2.8 (0.8 to 10.5) | |
| P value | NA | NA | |
| PASDAS | |||
| Adjusted mean change from baseline (95% CI) | −1.1 (−1.5 to −0.7) | −2.0 (−2.4 to −1.6) | −2.1 (−2.5 to −1.8) |
| Adjusted mean difference from placebo (95% CI) | −0.9 (−1.4 to −0.4) | −1.1 (−1.5 to −0.6) | |
| P value | 0.0003 | <0.0001 | |
| DAPSA | |||
| Adjusted mean change from baseline (95% CI) | −13.3 (−17.7 to −9.0) | −23.2 (−27.5 to −19.0) | −25.6 (−30.0 to −21.2) |
| Adjusted mean difference from placebo (95% CI) | −9.9 (−15.3 to −4.5) | −12.3 (−17.7 to −6.8) | |
| P value | 0.0004 | <0.0001 | |
| MDA | |||
| Response rate, % (95% CI) | 7.6 (1.2 to 14.0) | 22.9 (13.0 to 32.7) | 23.9 (13.7 to 34.1) |
| OR vs placebo (95% CI) | 3.8 (1.3 to 11.1) | 4.1 (1.4 to 12.2) | |
| P value | 0.0119 | 0.0068 | |
*Statistical analyses of primary and secondary endpoints at week 16 were adjusted for multiplicity. Additional endpoints were not controlled for multiple comparisons and nominal p values are reported.
†Response criteria of ≥0.35 improvement from baseline (minimum clinically important difference in PsA).
ACR, American College of Rheumatology; DAPSA, Disease Activity Index for Psoriatic Arthritis; HAQ-DI, Health Assessment Questionnaire-Disability Index; LEI, Leeds Enthesitis Index; MCS, Mental Component Summary; MDA, minimal disease activity; NA, not analysed; PASDAS, Psoriatic Arthritis Disease Activity Score; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Summary; PsA, psoriatic arthritis; SF-36, Short Form-36.