Indication | Study | Concomitant medications | Efficacy end point | Week | Adalimumab Response rate (%) | Placebo response rate (%) | Placebo-adjusted response rate (%) |
---|---|---|---|---|---|---|---|
Rheumatoid arthritis* | Weinblatt et al10 | MTX | ACR20 | 24 | 65 | 13 | 52 |
van de Putte et al11 | None | ACR20 | 26 | 46 | 19 | 27 | |
ACR20 | 24 | 63 | 30 | 33 | |||
Keystone et al12 | MTX | ACR20 | 52 | 59 | 24 | 35 | |
Furst et al13 | None | ACR20 | 24 | 53 | 35 | 18 | |
Psoriatic arthritis* | Mease et al14 | None | ACR20 | 12 | 58 | 14 | 44 |
ACR20 | 24 | 57 | 15 | 42 | |||
Genovese et al15 | None | ACR20 | 12 | 39 | 16 | 23 | |
Ankylosing spondylitis* | van der Heijde et al16 | None | ASAS20 | 12 | 58 | 21 | 37 |
Crohn's disease† | Hanauer et al17 | None | Clinical response‡ | 4 | 59 | 37 | 22 |
Sandborn et al18 | None | Clinical response | 4 | 52 | 34 | 18 | |
Colombel et al19 | None | Clinical response | 26 | 54 | 28 | 26 | |
Clinical response | 56 | 43 | 18 | 25 | |||
Ulcerative colitis†§ | Reinisch et al20 | None | Clinical remission¶ | 8 | 18 | 9 | 9 |
Sandborn et al21 | None | Clinical remission | 8 | 17 | 9 | 8 | |
Clinical response** | 52 | 30 | 18 | 12 | |||
Plaque psoriasis†† | Menter et al22 | None | PASI75 | 16 | 71 | 7 | 64 |
Saurat et al23 | None | PASI75 | 16 | 80 | 19 | 61 |
*Dosage of adalimumab for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: 40 mg every other week.
†Dosage of adalimumab for Crohn's Disease and Ulcerative Colitis: Initial dose (Day 1) is 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week.
‡Clinical response is defined as a decrease in the Crohn's Disease Activity Index ≥70.
§Ulcerative colitis is an approved indication for Humira in Europe by the EMA, but not in the USA by the FDA.
¶Clinical remission is defined as Mayo score ≤2 with no subscore >1.
**Clinical response is defined as a decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the RBS≥1 or an absolute RBS of 0 or 1.
††Dosage of adalimumab for plaque psoriasis: initial dose is 80 mg, followed by 40 mg every other week starting one week after initial dose.
ACR20, 20% improvement in the American College of Rheumatology criteria; ASAS20, 20% improvement in the Assessments in Spondyloarthritis international Society score; EMA, European Medicines Agency; EU, European Union; FDA, Food and Drug Administration; MTX, methotrexate; PASI75, 75% reduction in the Psoriasis Area and Severity Index score; RBS, rectal bleeding subscore.