Table 2.
Efficacy and long-term effectiveness of adalimumab in randomized controlled trials
| Reference | Study design | Intervention (n); comparator (n) | Study population % females; age range disease severity at baseline1 | Primary efficacy assessment | Results Psoriasis vulgaris: PASI 50, 75, 90 response rate Psoriatic arthritis: ACR 204, 50, 70 response rate
|
||
|---|---|---|---|---|---|---|---|
| Adalimumab | Comparator | ||||||
| Plaque psoriasis | |||||||
| Gordon 200648 | 12-week, double-blind, placebo-controlled RCT; open-label extension until week 60 | Adalimumab (A) 40 mg weekly (n = 50) vs A 40 mg eow2 (n = 46) vs placebo (n = 52) | 33% 20–86 years 16 | PASI 75 at week 12 | A 40 mg/week week 12 88%, 80%, 48% week 60 64%, 64%, 48% | A 40 mg/eow week 12 76%, 53%, 24% week 60 66%, 56%, 33% | Placebo week 12 n.r., 4%, n.r. |
| Menter 200849 | 16-week, double-blind, placebo-controlled RCT; open-label extension until week 52; rerandomization of responders at week 33 | A 40 mg eow (n = 814) vs placebo (n = 398) | 34% mean: 45 years 19 | PASI 75 at week 16 Loss of response2 between week 33 and 52 | Week 16
n.r., 71%, 45% Loss of response3 within 19 weeks after discontinuation: 5% |
Placebo
Week 16 n.r., 7%,2% Loss of response: 28% |
|
| Saurat 200850 | 16-week, double-blind RCT adalimumab vs methotrexate vs placebo | A 40 mg eow (n = 108) vs methotrexate initially 7.5 mg orally/week, increased as needed to 25 mg (n = 110) vs placebo (n = 53) | 34% mean 41 years 19 | PASI 75 at week 16 | 88%, 80%, 52% | Methotrexate 62%, 36%, 14%
Placebo 30%, 19%, 11% |
|
| Psoriatic arthritis | |||||||
| Mease 200557 Gladman 200756 Mease 200858 |
24-week, double-blind, placebo-controlled RCT, open-label extension study | A 40 mg eow (n = 151) vs placebo (n = 162) | 44% mean 49 years 14/25 | ACR 204 response at week 12 Mean change in modified total Sharp score at week 24 | ACR 20, 50, 70 response rates Week 12: 58%, 36%, 20% Week 48 (n = 151): 56%, 44%, 30%
Week 104 (n = 281): 57%, 45%, 30% Sharp score (structural joint damage) Week 24: −0.1 Week 48: +0.1 Week 144: +0.5 |
ACR response rates week 12 14%, 4%, 1%
Sharp score Week 24: +1.0 |
|
| Genovese 200759 | 12-week, double-blind, placebo-controlled RCT, open-label extension until week 24 | A 40 mg eow (n = 51) vs placebo (n = 49) | 46% mean 49 years 18/27 | ACR 20 response at week 12 | 39%, 25%, 14% | 16%, 2%, 0% | |
1
Notes: Psoriasis vulgaris: mean PASI at baseline, Psoriatic arthritis: mean number of swollen/tender joints;
2
every other week;
3
<PASI 50 and ≥6 Point increase in PASI;
4
American College of Rheumatology 20% improvement; n.r. not reported.