Table 2.
Variable | Month 0 | Month 3 | Month 6 | Month 9 | Month 12 | Month 18 | Month 24 |
---|---|---|---|---|---|---|---|
MDA | 0.9 (14/1578) | 27.0 (402/1488) | 35.5 (597/1684) | 37.3 (456/1223) | 41.3 (454/1098) | 43.3 (398/920) | 45.5 (348/764) |
TJC ≤1 | 4.2 (71/1684) | 39.6 (647/1635) | 46.6 (785/1684) | 50.5 (696/1377) | 52.5 (658/1253) | 54.4 (594/1091) | 57.8 (525/909) |
SJC ≤1 | 19.1 (321/1684) | 64.0 (588/1635) | 70.1 (1180/1684) | 71.9 (990/1377) | 75.2 (942/1253) | 75.5 (824/1091) | 81.1 (737/909) |
BSA ≤3%a | 34.4 (546/1587) | 57.0 (863/1513) | 64.8 (1901/1684) | 66.7 (838/1257) | 69.5 (781/1123) | 70.7 (666/924) | 70.8 (558/788) |
Pain ≤1 | 2.3 (39/1684) | 17.1 (276/1614) | 21.1 (353/1671) | 22.6 (307/1361) | 23.9 (293/1228) | 24.0 (258/1073) | 24.5 (218/890) |
PGA ≤2 | 0.6 (10/1674) | 31.5 (513/1629) | 40.1 (676/1684) | 42.3 (581/1374) | 45.1 (564/1251) | 47.2 (515/1092) | 49.3 (450/912) |
Functional remissionb | 29.5 (493/1674) | 46.4 (750/1618) | 47.4 (798/1684) | 49.4 (670/1356) | 54.0 (662/1226) | 52.4 (562/1072) | 55.1 (489/888) |
No enthesitis | 72.7 (1225/1684) | 87.1 (1425/1636) | 88.8 (1496/1684) | 90.3 (1254/1389) | 90.3 (1135/1257) | 90.6 (997/1100) | 92.0 (839/912) |
Data are presented as percentage of patients (number of patients who achieved criterion/number of patients with data for the specified outcome at this visit).
Baseline (month 0) MDA assessments were based on BSA <3% due to the use of pre-specified categories (<3, 3–10, 11–20 and >20%) for baseline BSA evaluations. Subsequent MDA assessments were based on BSA ≤3% as per the published MDA criterion due to BSA assessments at post-baseline visits as an estimated percentage without pre-specified categorizations.
FFbH ≥83% assessed on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity). BSA: body surface area; FFbH: Funktionsfragebogen Hannover; MDA: minimal disease activity; PGA: patient global disease activity assessment; SJC: swollen joint count; TJC: tender joint count.