Table 2.
MASES† | Week 24 | Week 52 | Week 104 | Week 156 | |||||
Placebo (n=302) |
Apremilast | Apremilast | Apremilast | Apremilast | |||||
30 mg two times per day (n=315) | 20 mg two times per day (n=298) | 30 mg two times per day (n=377) | 20 mg two times per day (n=326) | 30 mg two times per day (n=302) | 20 mg two times per day (n=261) | 30 mg two times per day (n=278) | 20 mg two times per day (n=227) | ||
Baseline, mean | 4.8 | 4.4 | 4.6 | 4.4 | 4.5 | 4.3 | 4.6 | 4.2 | 4.4 |
Mean change from baseline | −0.9 | −1.3‡ | −1.2 | −2.0 | −2.2 | −2.6 | −2.6 | −2.7 | −2.8 |
Mean per cent change from baseline | −7.0 | −23.6‡ | −19.3 | −43.5 | −42.2 | −57.5 | −55.2 | −65.2 | −57.6 |
Median per cent change from baseline§ | −21.1 | −50.0‡ | −40.0 | −66.7 | −66.7 | −85.7 | −100.0 | −100.0 | −100.0 |
Score of 0¶, n/m (%) | 70/311 (22.5) | 90/327 (27.5) | 84/307 (27.4) | 142/377 (37.7) | 134/326 (41.1) | 147/302 (48.7) | 135/261 (51.7) | 153/278 (55.0) | 125/227 (55.1) |
*The n at week 24 represents patients with a baseline value >0 and ≥1 postbaseline value at or before week 24. Data as observed for weeks 52, 104 and 156; the n represents the number of patients taking apremilast, regardless of when treatment started (baseline, week 16 or week 24), with a baseline value >0 and a value at the specific visit.
†MASES ranges from 0 to 13, with 0 indicating no pain at any assessed entheses and 13 indicating pain at all assessed entheses.
‡P<0.05 vs placebo.
§The per cent change noted occurred in >50% of patients.
¶Patients who did not have sufficient data (observed or imputed) for a definitive determination of response status at week 24 are counted as non-responders.
LOCF, last observation carried forward; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score.