Efficacy end points at week 16 (intent-to-treat population) and week 52 (data as observed)
| Week 16 (intent-to-treat population) | Week 52 (data as observed) | ||||||
|---|---|---|---|---|---|---|---|
| Placebo n=169 | Apremilast 20 mg twice daily n=169 | Apremilast 30 mg twice daily n=167 | Placebo/ apremilast 20 mg twice daily n=55 | Placebo/ apremilast 30 mg twice daily n=67 | Apremilast 20 mg twice daily n=120 | Apremilast 30 mg twice daily n=126 | |
| ACR20, n/m (%)* | 31/169 (18) | 48/169 (28)§ | 68/167 (41)|| | 32/54 (59) | 39/67 (58) | 65/116 (56) | 80/127 (63) |
| ACR50, n/m (%)* | 14/169 (8) | 21/169 (12) | 25/167 (15) | 15/53 (28) | 21/66 (32) | 30/119 (25) | 38/126 (30) |
| ACR70, n/m (%)* | 4/169 (2) | 8/169 (5) | 6/167 (4) | 11/53 (21) | 10/67 (15) | 11/120 (9) | 13/125 (10) |
| ACR response components | |||||||
| HAQ-DI (0–3), mean change (SD) | −0.07 (0.41) | −0.13 (0.45) | −0.20 (0.46)§ | −0.34 (0.41) | −0.34 (0.49) | −0.33 (0.51) | −0.35 (0.51) |
| HAQ-DI MCID ≥0.30†, n/m (%)* | 40/169 (24) | 52/169 (31) | 54/167 (32) | 31/55 (56) | 37/67 (55) | 55/122 (45) | 66/127 (52) |
| CRP (normal range: 0–0.5), mg/dL, mean change (SD) | −0.02 (1.25) | −0.23 (1.24) | −0.11 (1.78) | −0.02 (1.06) | −0.28 (1.17) | −0.23 (1.56) | −0.33 (1.68) |
| SJC (0–76), mean change (SD) | −1.3 (7.0) | −2.3 (8.6) | −3.5 (8.1)§ | −7.3 (6.0) | −7.1 (8.0) | −7.5 (9.5) | −7.8 (7.8) |
| SJC (0–76), mean per cent change (SD) | −9.6 (72.5) | −21.9 (72.4) | −24.5 (95.8) | −66.6 (38.6) | −69.1 (41.6) | −62.6 (44.3) | −66.8 (49.2) |
| TJC (0–78), mean change (SD) | −0.8 (8.9) | −4.0 (10.3)§ | −6.3 (10.5)|| | −8.4 (14.6) | −8.9 (8.9) | −11.0 (14.1) | −10.7 (11.5) |
| TJC (0–78), mean per cent change (SD) | 0.9 (67.8) | −24.8 (51.8)|| | −32.1 (55.5)|| | −46.4 (71.9) | −58.7 (45.1) | −53.8 (46.2) | −53.5 (47.6) |
| Patient's global assessment of disease activity (0–100 mm VAS), mean change (SD) | −4.1 (26.1) | −5.2 (30.3) | −9.7 (28.9)§ | −21.1 (23.4) | −15.3 (30.5) | −11.4 (27.4) | −17.9 (29.1) |
| Physician's global assessment of disease activity (0–100 mm VAS), mean change (SD) | −7.4 (21.1) | −13.9 (24.0)§ | −20.0 (22.3)|| | −29.8 (23.3) | −28.2 (20.4) | −30.4 (22.9) | −31.5 (21.0) |
| DAS-28 (CRP), mean change (SD) | −0.28 (1.0) | −0.57 (1.2)§ | −0.77 (1.1)|| | −1.3 (1.1) | −1.3 (1.2) | −1.2 (1.1) | −1.4 (1.2) |
| DAS-28 (CRP) <2.6, n/m (%)* | 13/169 (8) | 29/169 (17)§ | 30/167 (18)§ | 18/54 (33) | 26/67 (39) | 34/121 (28) | 38/127 (30) |
| PASI-50, n/m (%)*‡ | 21/89 (24) | 30/91 (33) | 37/90 (41)§ | 16/24 (67) | 19/35 (54) | 31/63 (49) | 35/64 (55) |
| PASI-75, n/m (%)*‡ | 7/89 (8) | 18/91 (20)§ | 19/90 (21)§ | 8/24 (33) | 10/35 (29) | 18/63 (29) | 25/64 (39) |
Note: For week 16 data, the n reflects the number of randomised patients; actual number of patients available for continuous parameters may vary slightly due to missing value at baseline or missing postbaseline value at or before week 16. For week 52 data, placebo/apremilast 20 mg twice daily and placebo/apremilast 30 mg twice daily groups include patients who were randomised to placebo at baseline and then randomised to apremilast 20 mg twice daily or 30 mg twice daily, respectively, at week 16 and week 24. Apremilast 20 mg twice daily and 30 mg twice daily groups include patients randomised to the respective regimen at baseline; data as observed. The n reflects the number of randomised patients who completed 52 weeks; actual number of patients may vary for each end point depending on availability of data.
*Patients who discontinued or did not have sufficient data at week 16 were counted as non-responders.
†Prespecified MCID threshold, based on the literature18 at the time of protocol development and analysis planning.
‡At week 16, examined among patients with body surface area ≥3% at baseline (placebo: n=89; apremilast 20 mg twice daily: n=91; apremilast 30 mg twice daily: n=90); at week 52, examined among patients with body surface area ≥3% at baseline and having data at week 52 (placebo/apremilast 20 mg twice daily: n=24; placebo/apremilast 30 mg twice daily: n=35; apremilast 20 mg twice daily: n=63; apremilast 30 mg twice daily: n=64).
§p<0.05; ||p≤0.0001 versus placebo, based on ANCOVA model for continuous end points and Cochran-Mantel-Haenszel test for categorical end points.
ACR, American College of Rheumatology; ANCOVA; analysis of covariance; CRP, C reactive protein; DAS-28, 28-joint disease activity score; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimal clinically important difference; PASI-75, 75% reduction from baseline Psoriasis Area and Severity Index score; SJC, swollen joint count; TJC, tender joint count; VAS, visual analogue scale.