Summary of change from baseline in primary and secondary clinical, glandular and patient-reported outcome measures at days 169 and 365
| Day 1 (baseline scores) | Day 169 (adjusted mean change from baseline [SE] scores) | Day 365 (adjusted mean change from baseline [SE] scores) | |||||
| Abatacept | Placebo | Abatacept | Placebo | Adjusted mean treatment difference for abatacept versus placebo (95% CI) | Abatacept | Placebo | |
| Disease activity | |||||||
| ESSDAI score | 8.7 (3.4) | 10.1 (5.0) | –3.2 (0.7) | –3.7 (0.7) | 0.5 (–0.7 to 1.6) | –3.8 (0.6) | –4.4 (0.6) |
| ESSDAI responders*, n/N (%) | NA | NA | 51/92 (55.4) | 55/95 (57.9) | –2.7 (–17.2 to 11.7)** | 44/92 (47.8) | 53/95 (55.8) |
| DAS28 (CRP) | 3.5 (1.3) | 3.6 (1.3) | –0.9 (0.1) | –1.1 (0.1) | 0.3 (0.0 to 0.5) | –0.9 (0.1) | –1.1 (0.1) |
| Physician GDA | 47.8 (17.3) | 47.8 (19.3) | –23.0 (2.4) | –23.7 (2.4) | 0.6 (–4.3 to 5.6) | ND | ND |
| Patient-reported outcomes | |||||||
| ESSPRI score | |||||||
| Total | 6.6 (2.1) | 6.5 (1.9) | –1.3 (0.3) | –1.5 (0.3) | 0.3 (–0.3 to 0.8) | –1.4 (0.3) | –1.5 (0.3) |
| Dryness | 7.0 (2.4) | 7.0 (2.3) | –0.8 (0.3) | –1.0 (0.3) | 0.2 (–0.5 to 0.8) | –1.2 (0.3) | –1.4 (0.3) |
| Fatigue | 6.6 (2.4) | 6.6 (2.5) | –1.3 (0.3) | –1.6 (0.3) | 0.3 (–0.4 to 0.9) | –1.9 (0.4) | –2.0 (0.3) |
| Pain | 6.1 (2.7) | 6.0 (2.7) | –1.1 (0.3) | –1.5 (0.3) | 0.3 (–0.3 to 1.0) | –1.3 (0.4) | –1.4 (0.3) |
| ESSPRI responders, n/N (%)‡ | NA | NA | 38/92 (41.3) | 50/95 (52.6) | –11.2 (–25.6 to 3.2)** | 38/92 (41.3) | 48/95 (50.5) |
| Ocular dryness, NRS§ | 6.8 (2.4) | 6.6 (2.5) | –0.9 (0.3) | –1.0 (0.3) | ND | –1.3 (0.4) | –1.4 (0.3) |
| Oral dryness, NRS§ | 7.3 (2.3) | 6.9 (2.5) | –1.3 (0.3) | –1.2 (0.3) | ND | –1.7 (0.3) | –1.6 (0.3) |
| Patient GDA | 58.6 (22.4) | 58.0 (21.1) | –10.1 (3.1) | –9.0 (3.0) | –1.1 (–7.4 to 5.1) | –12.9 (3.4) | –12.6 (3.2) |
| PROMIS-Fatigue | 61.2 (8.8) | 59.5 (8.6) | –5.6 (1.2) | –5.6 (1.1) | 0.04 (–2.3 to 2.4) | –6.5 (1.2) | –6.3 (1.2) |
| FSFI | 13.9 (8.7)†† | 17.3 (9.7)†† | –2.3 (1.7) | –1.9 (1.8) | –0.5 (–3.5 to 2.6) | –0.3 (1.0) | 2.3 (1.0) |
| Glandular function | |||||||
| Schirmer’s test, mm | 7.4 (9.4)†† | 5.0 (8.0)†† | 1.7 (1.1) | 1.0 (1.1) | 0.7 (–1.5 to 2.9) | 1.3 (1.2) | 2.4 (1.1) |
| TBUT, s | 4.7 (3.8)†† | 3.7 (3.1)†† | –0.2 (0.4) | –0.3 (0.4) | 0.1 (–0.8 to 0.9) | 0.3 (0.5) | –0.1 (0.5) |
| OSS | 6.1 (3.2)†† | 6.5 (3.5)†† | –1.5 (0.4) | –0.7 (0.4) | –0.7 (–1.6 to 0.1) | –1.8 (0.5) | –1.3 (0.2) |
| SWSF, mL/min | 1.1 (0.9) | 0.9 (0.8) | 0.1 (0.1) | 0.1 (0.1) | –0.1 (–0.2 to 0.1) | 0.1 (0.1) | 0.1 (0.1) |
| UWSF, mL/min | 0.1 (0.1)†† | 0.1 (0.1)†† | 0.02 (0.01) | 0.03 (0.01) | –0.004 (–0.03 to 0.03) | 0.02 (0.01) | 0.03 (0.01) |
Values are mean (SD) unless otherwise noted. Ocular assessments are for study eye. The primary and key secondary endpoints (except those marked §) were analysed by a longitudinal repeated measures model, which included randomisation stratification factors of current corticosteroid use (yes/no), current hydroxychloroquine use (yes/no), enrolment in Japan (yes/no) and SWSF </≥0.1 mL/min. Data at day 169, including adjusted mean treatment differences, are based on the primary analysis, while data at day 365 are based on the 1-year analysis. The change in outcome measures was equal to the difference between the values at baseline (day 1) and day 169 or day 365, as shown. The adjusted mean treatment difference was equal to the adjusted change in the abatacept group minus the adjusted change in the placebo group. Baseline data are for all randomised patients, except where marked with †, which were based on those patients included at day 29 or ††, which were based on day 85 (earliest post-baseline analysis) of the primary analysis. SWSF data at baseline and day 169 are for patients in the mITT population with SWSF of at least 0.1 mL/min at baseline and data at day 365 are for the overall mITT population; baseline measurements for this endpoint were from those patients included at day 169.
*Patients with minimally clinically important improvement from baseline (≥3 points) in ESSDAI total score.
**Estimate of difference (rather than adjusted mean treatment difference).
‡Patients with minimally clinically important improvement from baseline (≥1 point) in ESSPRI total score.
DAS28 (CRP), 28-joint Disease Activity Score based on C reactive protein; ESSDAI, EULAR Sjögren’s Syndrome Disease Activity Index; ESSPRI, EULAR Sjögren’s Syndrome Patient Reported Index; FSFI, Female Sexual Function Index; GDA, global disease assessment; NA, not available; ND, not determined; NRS, numeric rating scale; OSS, ocular staining scores; PROMIS-Fatigue, Patient-Reported Outcomes Measurement Information System Fatigue Score; SWSF, stimulated whole salivary flow; TBUT, tear break-up time; UWSF, unstimulated whole salivary flow.