NUCALA: Longer time in remission

Time in remission with NUCALA

Co-primary endpoint: Patients spent significantly more time in remission vs placebo over 52 weeks (OR: 5.9, 95% CI: 2.7, 13.0; P<0.001).1

Percentage of patients who achieved some time
in remission over 52 weeks

Remission graph

Subanalysis. Results are descriptive.

Based on the above co-primary endpoint2

The remission benefit of NUCALA 300mg + SOC was consistent regardless of:

  • Duration of disease
  • Use of concomitant immunosuppressant therapy
  • Baseline BVAS
  • Baseline vascular damage index

Preplanned analyses.

Remission as defined in the pivotal trial1*

Prednisolone or prednisone dose ≤4 mg/day

+

BVAS3†=0

 

No active vasculitis in any of 9 organ systems

Constitutional

Cutaneous

Nervous
system

ENT

Chest

Cardiovascular

Abdominal

Renal

Mucous
membranes/
eyes

Constitutional

Cutaneous

Nervous
system

ENT

Chest

Cardiovascular

Abdominal

Renal

Mucous
membranes/
eyes

The study definition was more stringent than the EULAR (European League Against Rheumatism) definition of remission (BVAS=0 and OCS dose ≤7.5 mg/day).1,4

BVAS (Birmingham Vasculitis Activity Score) is a standardized, validated measure of vasculitis. Scores can range from 0 to 63, with higher scores meaning more active disease.3,5

More patients in remission with NUCALA

Co-primary endpoint: Significantly more patients on NUCALA were in remission at both Week 36 and Week 48 vs placebo
(OR: 16.7, 95% CI: 3.6, 77.6; P<0.001).1 

Remission achieved at both Week 36 and Week 48

Remission pie charts

32%

NUCALA 300 mg + SOC
(n=22/68)

VS

Remission pie charts

3%

Placebo + SOC
(n=2/68)

BVAS=Birmingham Vasculitis Activity Score; CI=confidence interval; ENT=ear nose throat; OCS=oral corticosteroid; OR=odds ratio; SOC=standard of care.