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Phase II prospective open-label trial of recombinant interleukin-11 in women with mild von Willebrand disease and refractory menorrhagia

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: http://dx.doi.org/10.1160/TH11-04-0274
Issue: 2011: 106/4 (Oct) pp. 567–752
Pages: 641-645

Phase II prospective open-label trial of recombinant interleukin-11 in women with mild von Willebrand disease and refractory menorrhagia

M. V. Ragni (1, 2), R. C. Jankowitz (1), K. Jaworski (2), E. P. Merricks (3), M. T. Kloos (3), T. C. Nichols (3)

(1) Department of Medicine, Division of Hematology/Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA; (2) Hemophilia Center of Western Pennsylvania, Pittsburgh, Pennsylvania, USA; (3) Department of Pathology and Laboratory Medicine/ Francis Owen Blood Research Laboratory, University of North Carolina, Chapel Hill, North Carolina, USA

Keywords

Clinical Trial, women, von Willebrand disease, menorrhagia, interleukin-11

Summary

Lack of effective treatment for menorrhagia is the greatest unmet healthcare need in women with von Willebrand disease (VWD). We conducted a single-centre phase II clinical trial to determine efficacy and safety of recombinant IL-11 (rhIL-11, Neumega®) given subcutaneously for up to seven days during six consecutive menstrual cycles each in seven women with mild VWD and menorrhagia refractory to haemostatic or hormonal agents. rhIL-11 reduced menstrual bleeding severity as measured by pictorial blood assessment chart (PBAC) ≥50% (to <100) in 71% of subjects, cycle severity ≥50% in 71%, and bleeding duration ≥2 days in 85%, all p≤0.01. After rhIL-11, plasma VWF:RCo increased 1.1-fold, but did not correlate with PBAC, r=0.116, bleeding duration, r=0.318, or cycle severity, r=-0.295, or hsCRP, r=-0.003, all p>0.05. Platelet VWF mRNA expression by quantitative PCR increased mean four-fold (1.0–13.5). rhIL-11 was well tolerated with grade 1 or less fluid retention, flushing, conjunctival erythema, and local bruising. In summary, rhIL-11 reduces menorrhagia safely and warrants further study.

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