Phase II prospective open-label trial of recombinant interleukin-11 in women with mild von Willebrand disease and refractory menorrhagia*
Published Date:Aug 11 2011
Source:Thromb Haemost. 2011; 106(4):641-645.
Von Willebrand Disease
Von Willebrand Diseases
Von Willebrand Factor
Pubmed Central ID:PMC3947632
Funding:1-H-30-MC-00038-01/PHS HHS/United States
R24 HL063098/HL/NHLBI NIH HHS/United States
R24 HL063098-13/HL/NHLBI NIH HHS/United States
U10DD000193/DD/NCBDD CDC HHS/United States
UL-1 RR024153/RR/NCRR NIH HHS/United States
Description: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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