Pain Responder (NRS change score ≥ 20% decrease; n = 49) | Pain Nonresponder (NRS change score < 20% decrease; n = 68) | |||||||
---|---|---|---|---|---|---|---|---|
PRO Scores | Baseline Mean (SD) | Endpoint, Day 196 Mean (SD) | Change Score Mean (SD) | Effect Sizeb | Baseline Mean (SD) | Endpoint, Day 196 Mean (SD) | Change Score Mean (SD) | Effect Sizeb |
SF-36v2 subscale scores (0–100) | ||||||||
Bodily pain | 38.1 (10.5) | 46.8 (9.8) | 8.8 (9.1) | 0.8 | 36.4 (7.7) | 36.0 (8.5) | −0.4 (7.7) | −0.1 |
General health | 33.8 (10.0) | 39.4 (11.9) | 5.6 (7.5) | 0.6 | 34.3 (9.5) | 34.8 (9.5) | 0.5 (6.3) | 0.1 |
Mental health | 42.8 (12.5) | 46.9 (11.6) | 4.1 (10.0) | 0.3 | 42.1 (13.5) | 42.8 (13.3) | 0.7 (9.0) | 0.1 |
Physical functioning | 35.1 (10.9) | 42.0 (11.6) | 7.0 (9.7) | 0.6 | 33.7 (10.9) | 33.4 (10.6) | −0.3 (7.2) | 0.0 |
Role-emotional | 38.6 (13.3) | 43.5 (11.8) | 4.9 (13.1) | 0.4 | 35.1 (14.7) | 35.4 (15.3) | 0.3 (12.9) | 0.0 |
Role-physical | 36.9 (10.8) | 42.6 (10.5) | 5.7 (9.8) | 0.5 | 35.1 (10.4) | 34.0 (10.2) | −1.1 (8.9) | −0.1 |
Social functioning | 35.5 (12.3) | 44.2 (10.6) | 8.7 (10.6) | 0.7 | 36.0 (12.6) | 34.5 (12.9) | −1.5 (9.0) | −0.1 |
Vitality | 41.3 (11.3) | 46.7 (12.4) | 5.4 (9.3) | 0.5 | 39.5 (10.4) | 39.6 (11.1) | 0.2 (8.4) | 0.0 |
SF-36v2 summary scores (0–100) | ||||||||
Mental component summary | 41.2 (12.2) | 46.6 (11.5) | 4.5 (10.6) | 0.4 | 40.6 (13.5) | 40.9 (14.6) | 0.3 (9.5) | 0.0 |
Physical component summary | 34.9 (10.1) | 42.3 (10.8) | 7.4 (7.4) | 0.7 | 34.1 (9.0) | 33.3 (9.1) | −0.7 (6.2) | −0.1 |
Patient global health assessment NRS score (0–100) | 51.7 (26.5) | 25.7 (21.5) | −26.0 (21.6) | −1.0 | 46.3 (23.6) | 54.6 (24.2) | 8.2 (22.7) | 0.3 |
Physician global assessment of disease activity score (0–3) | 1.5 (0.5) | 0.8 (0.5) | −0.7 (0.6) | −1.5 | 1.4 (0.5) | 1.1 (0.6) | −0.3 (0.5) | −0.6 |
Higher SF-36v2 scores reflect better health status; higher scores indicate worse condition on other PRO measures (Patient global health assessment score and MDGA). Higher scores on the patient global health assessment score indicate worse overall status; higher MDGA scores indicate more severe disease.
↵a Patient pain NRS was used to identify pain responder status, where improvement was defined as a 20% or more decrease in pain NRS score from baseline to endpoint. Change scores were computed as change score = endpoint score–baseline score, where a negative change score represented improvement. Pain NRS change score ≥ 20% decrease was defined as a pain responder and pain NRS change score < 20% decrease was defined as a pain nonresponder.
↵b Effect size was computed as PRO change score/SD of PRO score at baseline. MDGA: physician global assessment; NRS: numeric rating scale; PRO: patient-reported outcome; SF-36v2: Medical Outcome Study Short Form-36 Health Survey Version 2; SLE: systemic lupus erythematosus; VAS: visual analog scale.