Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Mepolizumab, a Humanized Anti-IL-5 Antibody, Has Steroid-Sparing Potential in Churg-Strauss Syndrome.
Moosig1, Frank, Butherus1, Kristina, Hellmich2, Bernhard, Gross1, Wolfgang L.
In Churg-Strauss-Syndrome (CSS), a condition closely related to the hypereosinophilic syndrome (HES), high doses of glucocorticoids (GC) are often needed to control activity despite additional immunosuppression. Currently, severe cases demand treatment with cytotoxic agents such as cyclophosphamide and 1520% of patients are refractory to standard therapy. Therefore, new targeted therapeutic options are needed. Interleukin-5 (IL-5) is the major inductor of hypereosinophilia and eosinophils (EO) are believed to mediate organ damage. In HES, a steroid-sparing effect of mepolizumab has been demonstrated. Therefore, targeting IL-5 in CSS is reasonable.
In this phase II trial, we included 10 CSS patients with active disease (Birmingham vasculitis activity score [BVAS] >3) under standard therapy. After stopping previous immunosuppressive medication, except GC, 750 mg mepolizumab was administered IV every 4 weeks for a total of 9 infusions. GC were tapered, as feasible, without loss of disease control. Methotrexate was initiated after the last mepolizumab infusion.
The initial median BVAS was 9 (range 415), the GC dose 20 mg/d (range 12.570 mg/d) and the EO count 205/ml (range 134867/ml). One patient was excluded from the study because of non-compliance after 3 infusions. All 9 remaining patients reached remission (BVAS 0 and GC dose <7.5 mg/d prednisolone). GC dose could be reduced in all 9 patients (week 32: 4.5 mg/d [range 412.5 mg/d]). BVAS and EO counts improved significantly (week 32: BVAS 0 (0±0), p=0.0057; EO 18/ml (range 464.8/ml), p=0.0059). No severe adverse events attributable to mepolizumab occurred and the overall safety profile was good. After stopping mepolizumab, 2 patients experienced major and 3 minor relapse during a follow up of 10 months (range 414 months).
This phase II trial strongly suggests that mepolizumab may be an effective and safe therapeutic option in refractory CSS and might offer benefits beyond its steroid-sparing potential.
ClinicalTrials.gov Identifier: NCT00716651
To cite this abstract, please use the following information:
Moosig, Frank, Butherus, Kristina, Hellmich, Bernhard, Gross, Wolfgang L.; Mepolizumab, a Humanized Anti-IL-5 Antibody, Has Steroid-Sparing Potential in Churg-Strauss Syndrome. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :2203