Background: Mepolizumab (MEPO) proved its efficacy in the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in the randomised controlled MIRRA trial. The ANCA-associated vasculitis patient-reported outcomes (AAV-PRO) questionnaire is a novel, disease-specific tool, validated with the aim of assessing the impact of the disease and its treatment on the patients’ perspectives. Objectives: To prospectively evaluate the impact and the rapidity of the effect of MEPO on the AAV-PRO score and patient global assessment (PtGA) in a multicentre cohort of patients with EGPA. Methods: Patients with EGPA satisfying the 2022 ACR/EULAR and/or MIRRA trial classification criteria and initiating treatment with MEPO were included. PtGA and AAV-PRO score were prospectively evaluated at MEPO initiation and after 7, 14, 30, 90 and 180 days of treatment. Predictors of improved AAV-PRO response during treatment with MEPO were also investigated. Results: Seventy patients were included in the study: female 54.3%, mean age at diagnosis 48.7±12.6 years, 20% ANCA positive. Sixty-three patients (90%) had a history of relapsing disease. Forty-seven (67.1%) and 23 (32.9%) patients received MEPO 100 mg and 300 mg/4 weeks, respectively, with the main indication being refractory asthma and/or rhinosinusitis. Prednisone (PDN)-equivalent mean dose was 10.8±9.2 mg/day. At MEPO initiation, mean PtGA, total AAV-PRO, organ-specific symptoms, systemic symptoms, treatment side effects, social and emotional impact, concerns about the future and physical function domain 0-100 score were 59.1±21.2, 29.2±14.4, 30.9±17.8, 25.5±18.6, 18.8±18.1, 32.6±21.9, 37.7±22.1 and 28.2±21.2, respectively. After 7 days, a statistically significant reduction of both PtGA and total AAV-PRO 0-100 score [ratio 0.87 (95% CI 0.87—0.95); ratio 0.92, 95% CI (0.87—0.95), respectively; Table 1] was observed. At 14 days, all AAV-PRO domains, except treatment side effects, showed a statistically significant improvement compared to baseline. Conversely, no relevant amelioration of the AAV-PRO domains was demonstrated between 30 and 180 days of follow-up (Figure 1). Previous history of vasculitic relapse, BVAS ≤3, C-reactive protein ≤5 mg/L and PDN equivalent dose ≤10 mg/day at MEPO initiation were the main predictors of a better response of the AAV-PRO questionnaire during follow-up. MEPO 300 mg/4 weeks positively influenced organ-specific symptoms compared to MEPO 100 mg/4 weeks, although with a less significant improvement of the treatment side effects domain. Conversely, age, educational level and ANCA status at baseline had no impact on the AAV-PRO domains. Conclusion: MEPO allows a quick and remarkable improvement of several aspects of health-related quality of life in patients with refractory EGPA.
POS0320 IMPACT OF MEPOLIZUMAB ON PATIENT-REPORTED OUTCOMES IN EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS BY USING THE ANCA-ASSOCIATED VASCULITIS PATIENT-REPORTED OUTCOMES (AAV-PRO) QUESTIONNAIRE: A EUROPEAN MULTICENTRE PROSPECTIVE STUDY
Ricciardi, L.;
2024-01-01
Abstract
Background: Mepolizumab (MEPO) proved its efficacy in the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in the randomised controlled MIRRA trial. The ANCA-associated vasculitis patient-reported outcomes (AAV-PRO) questionnaire is a novel, disease-specific tool, validated with the aim of assessing the impact of the disease and its treatment on the patients’ perspectives. Objectives: To prospectively evaluate the impact and the rapidity of the effect of MEPO on the AAV-PRO score and patient global assessment (PtGA) in a multicentre cohort of patients with EGPA. Methods: Patients with EGPA satisfying the 2022 ACR/EULAR and/or MIRRA trial classification criteria and initiating treatment with MEPO were included. PtGA and AAV-PRO score were prospectively evaluated at MEPO initiation and after 7, 14, 30, 90 and 180 days of treatment. Predictors of improved AAV-PRO response during treatment with MEPO were also investigated. Results: Seventy patients were included in the study: female 54.3%, mean age at diagnosis 48.7±12.6 years, 20% ANCA positive. Sixty-three patients (90%) had a history of relapsing disease. Forty-seven (67.1%) and 23 (32.9%) patients received MEPO 100 mg and 300 mg/4 weeks, respectively, with the main indication being refractory asthma and/or rhinosinusitis. Prednisone (PDN)-equivalent mean dose was 10.8±9.2 mg/day. At MEPO initiation, mean PtGA, total AAV-PRO, organ-specific symptoms, systemic symptoms, treatment side effects, social and emotional impact, concerns about the future and physical function domain 0-100 score were 59.1±21.2, 29.2±14.4, 30.9±17.8, 25.5±18.6, 18.8±18.1, 32.6±21.9, 37.7±22.1 and 28.2±21.2, respectively. After 7 days, a statistically significant reduction of both PtGA and total AAV-PRO 0-100 score [ratio 0.87 (95% CI 0.87—0.95); ratio 0.92, 95% CI (0.87—0.95), respectively; Table 1] was observed. At 14 days, all AAV-PRO domains, except treatment side effects, showed a statistically significant improvement compared to baseline. Conversely, no relevant amelioration of the AAV-PRO domains was demonstrated between 30 and 180 days of follow-up (Figure 1). Previous history of vasculitic relapse, BVAS ≤3, C-reactive protein ≤5 mg/L and PDN equivalent dose ≤10 mg/day at MEPO initiation were the main predictors of a better response of the AAV-PRO questionnaire during follow-up. MEPO 300 mg/4 weeks positively influenced organ-specific symptoms compared to MEPO 100 mg/4 weeks, although with a less significant improvement of the treatment side effects domain. Conversely, age, educational level and ANCA status at baseline had no impact on the AAV-PRO domains. Conclusion: MEPO allows a quick and remarkable improvement of several aspects of health-related quality of life in patients with refractory EGPA.Pubblicazioni consigliate
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