Table 1.

Primary and secondary efficacy endpoints and post-hoc analyses, Week 52

Group, by IST treatmentCohortNΔmRSS, mean (SD)ΔFVC% mean (SD)ΔFVC, mL mean (SD)ΔHAQ-DI mean (SD)ACR CRISS median
mITT population, MMRM primary analysis method
AllPlacebo123-8.1 (7.72)-1.0 (8.68)-51 (317)-0.13 (0.468)0.887
Lenabasum 20 mg120-6.7 (6.59)-1.6 (6.91)-78 (265)-0.13 (0.436)0.888
Placebo subjects, per protocol completers, LOCF
No ISTPlacebo16-2.3 (9.4)-2.8 (7.4)-97 (244)0.12 (0.34)0.417
All ISTPlacebo97-8.9 (7.07)-1.0 (9.2)-43 (330)-0.17 (0.474)0.936
MMF, no other ISTPlacebo29-10.7 (8.1)-0.58 (7.1)-37 (235)-0.12 (0.456)0.935
MMF ≤ 2 years, no other ISTPlacebo23-11.7 (8.1)-0.3 (6.0)-41 (197)-0.13 (0.495)0.935
Non-MMF ≤ 2 yearsPlacebo24-6.7 (6.2)-1.4 (7.87)-52 (281)-0.15 (0.357)0.931
Post-hoc comparisons, per protocol completers, LOCF
No ISTPlacebo16-2.3 (9.4)-2.8 (7.4)-97 (244)0.12 (0.34)0.417
Lenabasum 20 mg10-6.3 (6.02)-2.3 (5.58)-99 (209)-0.06 (0.498)0.811
Established IST1Placebo26-6.1 (5.35)-4.6 (10.11)-170 (350)-0.17 (0.445)0.619
Lenabasum 20 mg38-7.4 (5.08)-0.4 (5.70)2-21 (233)3-0.07 (0.357)0.941
Established IST, subjects with ILDPlacebo22-5.9 (5.28)-3.7 (5.43)-133 (206)-0.10 (0.372)0.553
Lenabasum 20 mg33-7.2 (5.70)-1.0 (10.5)-47 (365)-0.06 (0.391)0.819
  • 2 P = 0.0386 two-sample t-test; 3 P = 0.0481 two-sample t-test; other comparisons were not significant