ASAS40 response for RINVOQ vs placebo at Week 14
Secondary (RINVOQ vs placebo at Week 14)*
• Change from baseline ASDAS†
• Change from baseline in SPARCC MRI spine score†
• BASDAl 50†
• ASAS partial remission†
• Change from baseline in BASFI†
• Change from baseline in ASQoL‡
• Change from baseline in BASMI‡
• Change from baseline in MASES‡
• Change from baseline in WPAI§
• Change from baseline in ASAS health index‡
Data for treatment-emergent adverse events and laboratory assessments were collected during the study. Treatment-emergent adverse events were defined as adverse events that began or worsened in severity after the first dose of study medication through 30 days after the last dose.
*The multiplicity-controlled secondary endpoints were tested in a sequential manner: ASDAS, SPARCC MRI spine, group of endpoints tested by Hochberg procedure (BASDAl 50, ASQoL, ASAS partial remission, BASFI, BASMI, MASES, and WPAI), and ASAS Health Index. ASAS Health Index could not be evaluated within the multiplicity-controlled sequence because some endpoints in the Hochberg procedure were not significant (NS).
†Statistically significant in multiplicity-controlled analysis.
‡Not multiplicity-controlled; nominal P<0.05 vs placebo. No clinical inferences can be drawn.
§Not multiplicity-controlled. No clinical inferences can be drawn.
ASAS: Assessment of Ankylosing Spondylitis International Society; ASDAS: Ankylosing Spondylitis Disease Activity Score; ASQoL: ankylosing spondylitis quality of life; BASDAI 50: at least 50% improvement in Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; BASMI: Bath Ankylosing Spondylitis Metrology Index; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; SPARCC MRI: Spondyloarthritis Research Consortium of Canada magnetic resonance imaging; WPAI: Work Productivity and Activity Impairment.