Vasculitis & polymyalgia rheumatica

The impact of treatment with avacopan on health-related quality of life in antineutrophil cytoplasmic antibody-associated vasculitis: a post-hoc analysis of data from the ADVOCATE trial

Lancet RheumatolPublished Post-hoc analysis of the ADVOCATE randomised controlled trial

Authors' conclusion

Patients with ANCA-associated vasculitis who received avacopan reported statistically significant and clinically meaningful improvements in health-related quality of life at 26 and 52 weeks and in health utility EQ-5D and SF-6D scores at 52 weeks.

Study context

Population
Patients with newly diagnosed or relapsing AAV
Participants
331 patients
Comparison
Avacopan vs prednisone taper
  • Avacopann = 166
  • Prednisonen = 165reference
Primary endpoint
Health-related quality of life: SF-36 v2 summary and domain scores, EQ-5D-5L and EQ-5D health utility; SF-6D health utility
Follow-up
Weeks 26 and 52
Methodological detailsphase 3, double-blind, double-dummy, modified intention-to-treat population
  • Phase 3
  • Double-blind
  • Double-dummy
  • Modified intention-to-treat population

Primary result

As reported in the abstract

SF-36 physical component summary, LS mean difference from baseline
  • Significantly greater in Avacopan than Prednisone at weeks 26 and 52
  • Significantly greater in Avacopan in five of eight SF-36 domains at week 26 and two of eight at week 52
  • Modified intention-to-treat population

Further findings

Proportion with scores ≥ normative values, SF-36 domains · weeks 26 and 52

Higher in Avacopan across all SF-36 domains; not statistically significant except role physical and vitality domains at week 26

LS mean change from baseline in EQ-5D-5L VAS, EQ-5D and SF-6D health utility scores · up to week 52

Significantly greater in Avacopan than Prednisone

Median total prednisone up to week 52

≈2500 mg less in Avacopan

Original publication

The impact of treatment with avacopan on health-related quality of life in antineutrophil cytoplasmic antibody-associated vasculitis: a post-hoc analysis of data from the ADVOCATE trial. Lancet Rheumatol. Published 24 July 2023. doi:10.1016/s2665-9913(23)00092-9

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