Table 3.
Dactylitis count† | Week 24 | Week 52 | Week 104 | Week 156 | |||||
Placebo (n=194) |
Apremilast | Apremilast | Apremilast | Apremilast | |||||
30 mg two times per day (n=214) | 20 mg two times per day (n=202) | 30 mg two times per day (n=249) | 20 mg two times per day (n=225) | 30 mg t two times per day (n=200) | 20 mg two times per day (n=182) | 30 mg two times per day (n=181) | 20 mg two times per day (n=157) | ||
Baseline, mean | 3.3 | 3.2 | 3.4 | 3.4 | 3.3 | 3.4 | 3.2 | 3.4 | 3.0 |
Mean change from baseline | −1.3 | −1.8‡ | −1.6 | −2.5 | −2.3 | −2.9 | −2.4 | −3.0 | −2.4 |
Mean per cent change from baseline | −38.2 | −48.6 | −43.2 | −67.9 | −70.2 | −80.0 | −75.6 | −83.6 | −73.4 |
Median per cent change from baseline§ | −66.7 | −79.3 | −75.0 | −100.0 | −100.0 | −100.0 | −100.0 | −100.0 | −100.0 |
Dactylitis count of 0¶, n/m (%) | 80/205 (39.0) | 102/221 (46.2) | 95/207 (45.9) | 168/249 (67.5) | 150/225 (66.7) | 155/200 (77.5) | 132/182 (72.5) | 144/181 (79.6) | 116/157 (73.9) |
*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.
†Dactylitis count is the sum of all scores for each of the 20 digits, with each digit scored as 0=absence or 1=presence of dactylitis.
‡P<0.01 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.