Efficacy outcome measures at week 2, week 16 and week 52†
| Week 2 | Week 16 | Week 52 | ||||
| Placebo n=109 | Apremilast n=110 | Placebo n=109 | Apremilast n=110 | Placebo/Apremilast n=91 | Apremilast n=80 | |
| ACR20, n/m (%) | 7/109 (6.4) | 18/110 (16.4)* | 22/109 (20.2) | 42/110 (38.2)‡ | 54/90 (60.0) | 53/79 (67.1) |
| ACR50, n/m (%) | 2/109 (1.8) | 3/110 (2.7) | 5/109 (4.6) | 20/110 (18.2)‡ | 26/91 (28.6) | 29/79 (36.7) |
| ACR70, n/m (%) | 0/109 (0.0) | 0/110 (0.0) | 0/109 (0.0) | 7/110 (6.4)* | 7/91 (7.7) | 17/80 (21.3) |
| DAS-28 (CRP), mean change | −0.31 | −0.59* | −0.39 | −1.07§ | −1.46 | −1.71 |
| SJC, mean % change | −17.5 | −27.7 | 4.2 | −46.4§ | −71.9 | −77.5 |
| TJC, mean % change | −16.2 | −14.8 | 2.5 | −32.3‡ | −61.4 | −70.4 |
| GEI (0–6), mean change¶ | −0.4 | −1.1* | −0.4 | −1.5‡ | −1.4 | −1.6 |
| GEI=0¶, n/m (%) | 10/51 (19.6) | 20/56 (35.7) | 17/51 (33.3) | 26/56 (46.4) | 24/43 (55.8) | 30/43 (69.8) |
| HAQ-DI score (0–3), mean change | −0.05 | −0.13* | −0.06 | −0.21* | −0.32 | −0.40 |
| HAQ-DI MCID ≥0.35, n/m (%) | 13/109 (11.9) | 24/110 (21.8) | 30/109 (27.5) | 39/110 (35.5) | 38/91 (41.8) | 40/80 (50.0) |
| SF-36v2 PF, mean change | NA | NA | −1.04 | 2.43‡ | 5.11 | 6.00 |
| SF-36v2 PCS, mean change | NA | NA | −0.31 | 4.03§ | 5.64 | 6.49 |
| Improvement in morning stiffness severity, n/m (%) | 23/109 (21.1) | 47/110 (42.7)‡ | 28/109 (25.7) | 51/110 (46.4)‡ | 52/91 (57.1) | 46/80 (57.5) |
| Morning stiffness duration (minutes), median % change | 0.00 | 0.00* | 0.00 | −33.33‡ | −41.67 | −55.00 |
*P<0.05 versus placebo; based on a Cochran-Mantel-Haenszel test for binary parameters and mixed-effects model for repeated measures for continuous parameters (except using stratified Van Elteren test for morning stiffness duration, with last-observation-carried-forward approach for missing data).
†Full analysis set was used for weeks 2 and 16; for response parameters, patients without sufficient data (observed or imputed) for the determination of response status were categorised as non-responders. Week 52 analyses were as observed; actual number of patients may vary for each outcome depending on availability of data.
‡P<0.005; §P≤0.0001 versus placebo; based on a Cochran-Mantel-Haenszel test for binary parameters and mixed-effects model for repeated measures for continuous parameters (except using stratified Van Elteren test for morning stiffness duration, with last-observation-carried-forward approach for missing data).
¶Evaluated in patients with enthesitis at baseline (GEI >0).
ACR20, 20% improvement in modified American College of Rheumatology response criteria; DAS-28 (CRP), 28-joint count Disease Activity Score using C reactive protein; GEI, Gladman Enthesitis Index; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimal clinically important differences; NA, not assessed at time point; n/m, number of responders/number of patients with sufficient data for evaluation; PCS, physical component summary; PF, Physical Functioning domain; SF-36v2, 36-item Short-Form Health Survey version 2.