Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
A randomised, blinded, placebo-controlled, dose escalation study of the tolerability and efficacy of filgrastim for haemopoietic stem cell mobilisation in patients with severe active rheumatoid arthritis
Autore:
Snowden, JA; Biggs, JC; Milliken, ST; Fuller, A; Staniforth, D; Passuello, F; Renwick, J; Brooks, PM;
Indirizzi:
St Vincents Hosp, Dept Haematol, Sydney, NSW 2010, Australia St Vincents Hosp Sydney NSW Australia 2010 l, Sydney, NSW 2010, Australia St Vincents Hosp, Med Professorial Unit, Sydney, NSW 2010, Australia St Vincents Hosp Sydney NSW Australia 2010 t, Sydney, NSW 2010, Australia Amgen Australia, Melbourne, Vic, Australia Amgen Australia Melbourne Vic Australia ralia, Melbourne, Vic, Australia
Titolo Testata:
BONE MARROW TRANSPLANTATION
fascicolo: 11, volume: 22, anno: 1998,
pagine: 1035 - 1041
SICI:
0268-3369(199812)22:11<1035:ARBPDE>2.0.ZU;2-T
Fonte:
ISI
Lingua:
ENG
Soggetto:
COLONY-STIMULATING FACTOR; BONE-MARROW TRANSPLANTATION; SEVERE AUTOIMMUNE-DISEASES; COLLAGEN-INDUCED ARTHRITIS; FACTOR G-CSF; FELTYS-SYNDROME; FLARE-UP; LEUKOCYTOCLASTIC VASCULITIS; INDUCED AGRANULOCYTOSIS; NEUTROPENIA;
Keywords:
rheumatoid arthritis; stem cell transplantation; granulocyte colony-stimulating factor;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
55
Recensione:
Indirizzi per estratti:
Indirizzo: Snowden, JA Royalandllamshire Hosp, Dept Haematol, Sheffield S10 2JF, S Yorkshire, Engl Royal Hallamshire Hosp Sheffield S Yorkshire England S10 2JF
Citazione:
J.A. Snowden et al., "A randomised, blinded, placebo-controlled, dose escalation study of the tolerability and efficacy of filgrastim for haemopoietic stem cell mobilisation in patients with severe active rheumatoid arthritis", BONE MAR TR, 22(11), 1998, pp. 1035-1041

Abstract

Autologous haemopoietic stem cell transplantation (HSCT) represents a potential therapy for severe rheumatoid arthritis (RA), As a prelude to clinical trails, the safety and efficacy of haemopoietic stem cell (HSC) mobilisation required investigation as colony-stimulating factors (CSFs) have been reported to flare RA, A double-blind, randomised placebo-controlled dose escalation study was performed. Two cohorts of eight patients fulfilling strict eligibility criteria for severe active RA (age median 40 Sears, range 24-60 years; median disease duration 10.5 years, range 218 years) received filgrastim (r-Hu-methionyl granulocyte(G)CSF) at 5 and 10 mu g/kg/day, randomised in a 5:3 ratio with placebo. Patients were unblinded on the fifth day of treatment and those randomised to filgrastim underwent cell harvesting (leukapheresis) daily until 2 x 10(6)/kg CD34(+) cells (haemopoietic stem andprogenitor cells) were obtained. Patients were assessed by clinical and laboratory parameters before, during and after filgrastim administration. RA flare was defined as an increase of 30% or more in two of the following parameters: tender joint count, swollen joint count or pain score. Efficacy was assessed by quantitation of CD34+ cells and CFU-GM, One patient in the 5 mu g/kg/day group and two patients in the 10 mu g/kg/day group fulfilled criteria for RA flare, although this did not preclude successful stem cell collection. Median changes in swollen and tender joint counts were not supportive of filgrastim consistently causing exacerbation of disease, but administration of filgrastim at 10 mu g/kg/day was associated with rises in median C-reactive protein and median rheumatoid factor compared with placebo. Other adverse events were well recognised for filgrastim and included bone pain (80%) and increases in alkaline phosphatase (four-fold) and lactate dehydrogenase (two-fold), With respect to efficacy, filgrastim at 10 mu g/kg/day was more efficient with all patients (n = 5) achieving target CD34(+) cell counts with a single leukapheresis (median = 2.8, range = 2.3-4.8 x 10(6)/kg, median CFU-GM = 22.1, range = 4.2-102.9 x 10(4)/kg), whereas 1-3 leukaphereses were necessary to achieve the target yield using 5 mu g/kg/day, Weconclude that filgrastim may be administered to patients with severe active RA for effective stem cell mobilisation. Flare of RA occurs in a minorityof patients and is more likely with 10 than 5 mu g/kg/day. However, on balance, 10 mu g/kg/day remains the dose of choice in view of more efficient CD34(+) cell mobilisation.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/01/20 alle ore 03:46:04