TABLE 1.
Summary of upadacitinib key registrational trials supporting approved indications and summary of upadacitinib efficacy compared to placebo for key efficacy endpoints from representative registrational clinical trials across approved indications.
| Patient population | UPA approved dose | Study | Doses evaluated | Comparator | Efficacy endpoint | Efficacy timepoint | Percentage of subjects achieving efficacy endpoint | ||
|---|---|---|---|---|---|---|---|---|---|
| UPA | Placebo | Active comparator | |||||||
| RA | 15 mg q.d. | SELECT‐COMPARE (NCT02629159) | 15 mg q.d. | Placebo/Adalimumab 40 mg eow | ACR20 | Week 12 | 459/651 (71%) | 237/651 (36%) | 206/327 (63%) |
| RA | 15 mg q.d. |
SELECT‐MONOTHERAPY |
15 and 30 mg q.d. | Methotrexate | ACR20 | Week 14 | 147/217 (68%) | – | 89/216 (41%) |
| RA | 15 mg q.d. |
SELECT‐NEXT |
15 and 30 mg q.d. | Placebo | ACR20 | Week 12 | 141/221 (64%) | 79/221 (36%) | – |
| RA | 15 mg q.d. |
SELECT‐BEYOND |
15 and 30 mg q.d. | Placebo | ACR20 | Week 12 | 106/164 (65%) | 48/169 (28%) | – |
| RA | 15 mg q.d. |
SELECT‐EARLY |
7.5, 15, and 30 mg q.d. | Methotrexate | ACR50 | Week 12 | 165/317 (52%) | – | 89/314 (28%) |
| PsA | 15 mg q.d. |
SELECT‐PsA 1 |
15 and 30 mg q.d. | Placebo/Adalimumab 40 mg eow | ACR20 | Week 12 | 303/429 (71%) | 153/423 (36%) | 279/429 (65%) |
| PsA | 15 mg q.d. |
SELECT‐PsA 2 |
15 and 30 mg q.d. | Placebo | ACR20 | Week 12 | 120/211 (57%) | 51/212 (24%) | – |
| AS | 15 mg q.d. |
SELECT‐AXIS 1 |
15 mg q.d. | Placebo | ASAS 40 | Week 14 | 48/93 (52%) | 24/94 (26%) | – |
| AS | 15 mg q.d. |
SELECT‐AXIS 2 Study 1 |
15 mg q.d. | Placebo | ASAS 40 | Week 14 | 94/211 (45%) | 38/209 (18%) | – |
| nr‐axSpA | 15 mg q.d. |
SELECT‐AXIS 2 Study 2 |
15 mg q.d. | Placebo | ASAS 40 | Week 14 | 70/156 (45%) | 35/157 (23%) | – |
| AD | 15 mg q.d. |
MEASURE UP 1 |
15 and 30 mg q.d. | Placebo | EASI75 | Week 16 | 196/281 (70%) | 46/281 (16%) | – |
| AD | 30 mg q.d. |
MEASURE UP 1 |
15 and 30 mg q.d. | Placebo | EASI75 | Week 16 | 227/285 (80%) | 46/281 (16%) | – |
| AD | 15 mg q.d. |
MEASURE UP 2 |
15 and 30 mg q.d. | Placebo | EASI75 | Week 16 | 166/276 (60%) | 37/278 (13%) | – |
| AD | 30 mg q.d. |
MEASURE UP 2 |
15 and 30 mg q.d. | Placebo | EASI75 | Week 16 | 206/282 (73%) | 37/278 (13%) | – |
| AD | 15 mg q.d. |
AD UP |
15 and 30 mg q.d. + TCS | Placebo | EASI75 | Week 16 | 194/300 (65%) | 80/304 (26%) | – |
| AD | 30 mg q.d. |
AD UP |
15 and 30 mg q.d. + TCS | Placebo | EASI75 | Week 16 | 229/297 (77%) | 80/304 (26%) | – |
| AD | 30 mg q.d. |
HEADS UP |
30 mg q.d. | Dupilumab | EASI75 | Week 16 | 247/348 (71%) | – | 210/344 (61%) |
| UC |
45 mg q.d. (Induction) |
U‐ACHIEVE |
45 mg q.d. | Placebo | Clinical remission | Week 8 | 83/319 (26%) | 7/154 (5%) | – |
| UC |
45 mg q.d. (Induction) |
U‐ACCOMPLISH |
45 mg q.d. | Placebo | Clinical remission | Week 8 | 114/341 (34%) | 7/174 (4%) | – |
| UC |
15 mg q.d. (Maintenance) |
U‐ACHIEVE Maintenance |
15 and 30 mg q.d. | Placebo | Clinical remission | Week 52 | 63/148 (42%) | 8/149 (12%) | – |
| UC |
30 mg q.d. (Maintenance) |
U‐ACHIEVE Maintenance |
15 and 30 mg q.d. | Placebo | Clinical remission | Week 52 | 80/154 (52%) | 8/149 (12%) | – |
| CD |
45 mg q.d. (Induction) |
U‐EXCEL |
45 mg q.d. | Placebo | Clinical remission | Week 12 | 173/350 (50%) | 51/176 (29%) | – |
| CD |
45 mg q.d. (Induction) |
U‐EXCEED |
45 mg q.d. | Placebo | Clinical remission | Week 12 | 126/324 (39%) | 36/171 (21%) | – |
| CD |
15 mg q.d. (Maintenance) |
U‐ENDURE |
15 and 30 mg q.d. | Placebo | Clinical remission | Week 52 | 63/169 (37%) | 25/165 (15%) | – |
| CD |
30 mg q.d. (Maintenance) |
U‐ENDURE |
15 and 30 mg q.d. | Placebo | Clinical remission | Week 52 | 80/168 (48%) | 25/165 (15%) | – |
Abbreviations: ACR20, 20% improved in disease activity defined by the American College of Rheumatology; AD, atopic dermatitis; AS, ankylosing spondylitis; ASAS40, 40% improvement from baseline defined by theAssessment in Spondyloarthritis International Society; CD, Crohn’s disease; EASI75, 75% reduction from baseline in the Eczema Area and Severity Index; e.o.w., every other week; nr‐axSpA, non‐radiographic axial spondyloarthritis; PsA, psoriatic arthritis; q.d., once‐daily; RA, rheumatoid arthritis; TCS, topical corticosteroid; UC, ulcerative colitis; UPA, upadacitinib.