Treatment effectiveness for enthesitis outcomes in randomized controlled trials in psoriatic arthritis.
| Study | Agent | No. | Enthesitis Measure | Results (p value vs placebo, at followup) | Effect Size [95%CI] |
|---|---|---|---|---|---|
| Clegg 199615 | Sulfasalazine, 2 g qd | 221 | Modified Mander Enthesitis Index | Mean at baseline (± SD)/ mean change (± SD) 36 wks. S: 4.3 ± 5.9/–1.5 ± 4.5; P: 4.4 ± 5.6/–0.9 ± 4.1; NS | –0.1 [–0.4, 0.1] |
| Antoni 20058 | Infliximab, 5 mg/kg q8w | 104 | IMPACT Index | % at baseline/16 wks. I: 25/14. P: 25/31 (p = 0.021) | NA |
| Antoni 20059 | Infliximab, 5 mg/kg q8w | 200 | IMPACT Index | % at baseline/14 wks/24 wks. I: 42/22/20; P: 35/34/37; (p = 0.016/p = 0.002) | NA |
| Mease 200510 | Adalimumab, 40 mg q2w | 313 | IMPACT Index | NR/NS | NA |
| Genovese 200711 | Adalimumab, 40 mg q2w | 100 | IMPACT Index | Mean (± SD) at baseline/mean change 16 wks. Ad: 0.9 ± 1.2/–0.5; P: 1.0 ± 1.3/–0.2; NS | –0.24 [–0.6, 0.2] |
| Kavanaugh 20097,12 | Golimumab, 50 mg q4w; 100 mg q4w | 406 | PsA modified MASES | % at baseline/14 wks/24 wks. G100: 79/61/50 (NS/p = 0.003); G50: 75/55/49 (p = 0.008/p = 0.002); P:78/71/69 | |
| Mean (± SD) at baseline/mean % change 24 wks. G100: 6.1 ± 4.1/–52.4 (p < 0.001) | –0.62 [–0.9, −0.4] | ||||
| G50: 5.7 ± 4.0 /–46.1 (p < 0.001) | –0.49 [–0.7, −0.2] | ||||
| Gtot: 5.9 ± 4.1/–49.4 (p < 0.001); P: 5.0 ± 4.1/–12.9 | –0.55 [–0.8, −0.3] | ||||
| Gottlieb 200913 | Ustekinumab, 90 mg or 63 mg qw for 4 wks | 146 | IMPACT Index | % at baseline/12 wks. U: 45/23; P: 46/42; p = 0.0163 | NA |
| Sterry* 201014 | Etanercept, 50 mg biw/qw; 50 mg qw/qw | 752 | IMPACT Index | % at baseline/improved** 12 wk/24 wk. E (biw/qw): 40.4/73.7/80.9; E (qw/qw): 35.9/70.0 /81.3; (NR) | NA |
| McInnes 201316 | Ustekinumab, 45 mg q12w; 90 mg q12w | 615 | PsA modified MASES | % at baseline/24 wks. U90: 75.5/60.8 (p = 0.0002); U45: 69.3/68.6 (p = 0.0179); P: 70.4/81.0 | |
| Mean (± SD) at baseline/mean change 24 wks | |||||
| U90: 5.7 ± 3.8/–2.5 (p = 0.002)^ | –0.31 [–0.5, −0.1] | ||||
| U45: 5.0 ± 3.6/–2.0 (p = 0.057)^ | –0.19 [–0.4, 0.0] | ||||
| Utot: 5.4 ± 3.7/–2.2 (p = 0.003)^; P: 5.4 ± 3.9/–1.3 | –0.25 [–0.4, −0.1] | ||||
| Ritchlin 201419 | Ustekinumab, 45 mg q12w; 90 mg q12w | 312 | PsA modified MASES | % at baseline/24 wks U90: 72.4/70.0 (p = 0.01) U45: 69.9/75.7 (p < 0.05); P: 70.2/88.2 | |
| Mean (± SD) at baseline/mean change 24 wks. U90: 5.7 ± 3.9/–2.1 (p = 0.08)^ | –0.24 [–0.5, 0.3] | ||||
| U45: 6.5 ± 3.9/–1.9 (p = 0.16) ^ | –0.19 [–0.5, 0.1] | ||||
| Utotal: 6.1 ± 3.9/–2.0 (p = 0.07); P: 5.5 ± 4.3/–1.1 | –0.22 [–0.5, 0.1] | ||||
| Mease 201417 | Certolizumab, 400 mg q4wk; 200 mg q2wk | 409 | LEI | Mean(± SD) at baseline/change (± SD) 24 wks. C400: 2.9 ± 1.6/−1.8 ± 1.9 (p = 0.003) | –0.44 [–0.7, −0.2] |
| C200: 3.1 ± 1.7/–2.0 ± 1.8 (p < 0.001); P: 2.9 ± 1.6/–1.1 ± 1.8 | –0.55 [–0.8, −0.3] | ||||
| Kavanaugh 201418 | Apremilast, 20 mg bid, 30 mg bid | 504 | MASES | Mean(± SD)at baseline/change (± SE) 24 wks | |
| Ap30: 4.4 ± 3.1/–1.7 ± 0.3 (p = 0.03) | –0.27 [–0.5, −0.1] | ||||
| Ap20: 5.0 ± 3.3/–1.6 ± 0.3 (NS); P: 5.4 ± 3.5/–0.8 ± 0.3 | –0.24 [–0.5, −0.2] |
↵* All studies are double-blind randomized controlled trials (DBRCT) except for Sterry 2010 (2 active arms).
↵** % with improvement in ≥ 1 site.
↵^ p values for comparison of means calculated using the t test. NA: not applicable; NR: not reported; NS: not significant; Ad: adalimumab; Ap: apremilast; C: certolizumab; E: etanercept; G: golimumab; I: infliximab; P: placebo; S: sulfasalazine; U: ustekinumab; bid: twice daily; biw: twice weekly; qd: daily; qw: weekly. Values in bold face are statistically significant.