N/A
N=118
Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan
Churg-Strauss Syndrome · Eosinophilic Granulomatosis With Polyangiitis
Bottom Line
View on ClinicalTrials.gov: NCT04551989 ↗Enrolled (actual)
118
Serious AEs
22.0%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) — 69; 26; 42 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) |
69; 26; 42 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions (ADRs) |
— | — |
| SECONDARY Percentage of Participants With Clinical Symptoms |
90; 10; 0; 10; 92; 7 | — |
| SECONDARY Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse |
10 | — |
| SECONDARY Annualized Rate of Hospitalization for EGPA-related Events |
0.02 | — |
| SECONDARY Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events |
0.07 | — |
| SECONDARY Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) |
3.00; 3.00; 2.50; 2.00; 2.00; 2.00 | — |
| SECONDARY Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) |
37; 45; 23; 13; 36; 46 | — |
Summary
Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as the Churg-Strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels. NUCALA® (mepolizumab 300 milligrams [mg], subcutaneous administration) was approved in Japan in 2018 for the treatment of EGPA in adult participants. This is a single-arm, multi-center, prospective, non-interventional study that aims to assess long-term (2 to 4 years) real-world safety and effectiveness of NUCALA. Approximately 120 participants who completed the NUCALA Post Marketing Surveillance (PMS) study (National Clinical Trial [NCT]03557060) will be enrolled in the study.
NUCALA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Eligibility Criteria
Inclusion Criteria
- Adult participants with EGPA of >=20 years of age inclusive, at the time of signing the informed consent.
- Participants must have a current clinical diagnosis of EGPA by physician.
- Participants have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan.
- Participants thus were registered and completed the NUCALA PMS study (special drug use investigation; Protocol Number 208505, NCT03557060) prior to be enrolled in this study.
- Physician's decision to continue treatment with NUCALA for the treatment of EGPA as mentioned in the current label in Japan.
- Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.
Exclusion Criteria
- Participants who have previously discontinued NUCALA treatment for EGPA for more than 12 weeks.
- Participating in another clinical trial within the past 12 months, in which the participant has been exposed to an investigational or non-investigational pharmaceutical product.
- Participants with any reasons that in physician's opinion would place the participants at risk.
- Participants who are pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT04551989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.