title: Lack of seasonal variation in bleeding and patient-assessed pain patterns in patients with haemophilia B receiving on-demand therapy.
abstract: Spontaneous haemorrhage in patients with haemophilia is generally considered to occur randomly and without a predictable temporal or seasonal pattern; however, there is a lack of evidence in the literature on the effects of weather, temperature and atmosphere on bleeding episodes. This post hoc analysis of a multicentre, open-label crossover study examined the influence of seasonality on bleeding frequency and patient-assessed pain in patients with moderately severe and severe (FIX C ≤ 2%) haemophilia B. Fifty patients were enrolled and treated on-demand for 16 weeks; 47 were subsequently randomized to one of two prophylactic regimens (nonacog alfa 100 IU kg(-1) once weekly or 50 IU kg(-1) twice weekly) for 16 weeks. Patients then underwent an 8-week washout period of on-demand therapy before being crossed over to the other prophylactic regimen for 16 weeks. Bleeding episodes during the on-demand treatment periods were analysed. To assess for temporal trends, data were graphed as scatter plots. The primary end point was the annualized bleeding rate (ABR). Additional measures included raw and median pain scores during every joint bleeding event (spontaneous or traumatic), with pain scored using the Brief Pain Inventory (0 = 'no pain' to 10 = 'pain as bad as you can imagine'). The observed ABRs during the on-demand periods showed no distinguishable trend over time. Analysis of pain associated with joint bleeding episodes also did not demonstrate any discernible temporal trend. No apparent seasonal variation in bleeding pattern or patient-reported pain was observed in this analysis of patients with haemophilia B.
authors.affiliation: Pfizer Inc, Collegeville, PA, USA.
authors.forename: F
authors.initials: F
authors.lastname: Shafer
authors.forename: L
authors.initials: L
authors.lastname: Smith
authors.forename: N
authors.initials: N
authors.lastname: Vendetti
authors.forename: P
authors.initials: P
authors.lastname: Rendo
authors.forename: M
authors.initials: M
authors.lastname: Carr
mesh_terms: D000293:Adolescent; D000328:Adult; D018592:Cross-Over Studies; D005164:Factor IX / Q000008:administration & dosage; D005260:Female; D002836:Hemophilia B / Q000188:drug therapy* / Q000503:physiopathology*; D006470:Hemorrhage / Q000188:drug therapy / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012651:Self Medication; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D005164:Factor IX
keywords: factor IX; haemophilia B; pain; recombinant factor IX; seasonality