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Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group study

Berth-Jones, John ; Damstra, Robert J ; Golsch, Stefan ; Livden, John K ; Van Hooteghem, Oliver ; Allegra, Fulvio ; Parker, Christine A

BMJ, 2003-06, Vol.326 (7403), p.1367-1370 [Periódico revisado por pares]

London: British Medical Journal Publishing Group

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  • Título:
    Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group study
  • Autor: Berth-Jones, John ; Damstra, Robert J ; Golsch, Stefan ; Livden, John K ; Van Hooteghem, Oliver ; Allegra, Fulvio ; Parker, Christine A
  • Assuntos: Adolescent ; Adult ; Aged ; Androstadienes - administration & dosage ; Androstadienes - adverse effects ; Atopic dermatitis ; Biological and medical sciences ; Corticosteroids ; Cream ; Dermatitis ; Dermatitis, Atopic - prevention & control ; Dermatologic Agents - administration & dosage ; Dermatologic Agents - adverse effects ; Dermatology ; Disease-Free Survival ; Double-Blind Method ; Drug Administration Schedule ; Emollients ; Emollients - administration & dosage ; Emollients - adverse effects ; Fluticasone ; Humans ; Lesions ; Medical research ; Medical sciences ; Medical treatment ; Middle Aged ; Ointments ; Pharmacology. Drug treatments ; Placebos ; Primary Care ; Propionates ; Relapse ; Risk Factors ; Secondary Prevention ; Skin, nail, hair, dermoskeleton ; Treatment Outcome
  • É parte de: BMJ, 2003-06, Vol.326 (7403), p.1367-1370
  • Notas: href:bmj-326-1367.pdf
    PMID:12816824
    J Berth-Jones
    istex:1494802DA1462ACF31CAC13F984F3F85E1FAD3BD
    ark:/67375/NVC-1M9VS87D-3
    ArticleID:bmj.326.7403.1367
    local:bmj;326/7403/1367
    J Berth-Jones johnberthjones@a ol.com
    The authors thank the following investigators who recruited patients and took part in this study (Study FLTB4012): Belgium: M Creusot, J Delescluse, P-D Ghislain, S Henne, A Henrijean, N Kiesch, J Lambert, K Lapiere, A-F Leclerc, B Leroy, L Monbaliu, V Reding, M Song, J De Weert. Germany: E Christophers, M L Gruppi, W Kloevekorn, L Malek, M Meurer, T Ruzicka, G Wozel. Italy: P Barachini, A Garcovich, M Gatti, R Gianfaldoni, A Giannetti, G Micali, M L Musumeci, A Pompili, M B Santoni, A
    Funding: Glaxo Wellcome (now GlaxoSmithKline) R & D, United Kingdom.
    Sapuppo, S Seidenari, A G Di Stefano. Netherlands: L H van Bergen,P J M J Bessems, N H C M N Crombag, H J L van Gerwen,M I Koedam,G R R Kuiters, J C C A Lambers,A P Oranje, R L M A Prevoo,H B Thio,K H Tjiam, A Wolkerstorfer. Norway: L Aulie, J Austad, L I Hanssen, T Langeland, N-J Mork. United Kingdom: S Agarwal, G Barclay, J N Barker, S Blackford, J E Bothwell, R Burd, G J Charlwood, G Charlwood, M M Chowdhury, A C Chu, S Davison, H P Drewitt, L C Fuller, R A C Graham-Brown, S A Hall, K Jackson, J E Mellerio, G Osborne, O M V Schofield, C H Smith, A Takwale, C P S Thorpe, B P Wood.
    Contributors: JBJ and CP were involved in the design of the study, as were Robin Graham Brown (Leicester Royal Infirmary, UK) and Jan B van der Meer (Academic Hospital, Groningen, Netherlands). Eltjo J Glazenburg (GSK), Michael Herdman (GSK consultant) and Julie Duncan (GSK) were also involved in the design of the study and contributed to discussion of results. All named authors commented on the study design, took part in the study and contributed to the interpretation of analysed data during the preparation, review and approval of the final manuscript. Martin J Rimmer (GSK) provided statistical advice during the writing of the paper and Susan Daly (GSK consultant) managed the publication process through to the final manuscript. JBJ is the guarantor.
    Ethical approval: The study was approved by appropriate local research ethics committees.
    Competing interests: CP is employed full time by GlaxoSmith-Kline.
  • Descrição: Abstract Objective To explore the efficacy and safety of fluticasone propionate, cream and ointment, applied twice weekly in addition to maintenance treatment with emollients, in reducing the risk of relapse of chronic recurrent atopic dermatitis. Design Randomised, double blind, parallel group study of 20 weeks' duration. Setting Dermatology outpatient clinics (6 countries, 39 centres). Participants Adult (aged 12-65) patients with moderate to severe atopic dermatitis who were experiencing a flare. Methods Participants applied fluticasone propionate (0.05% cream or 0.005% ointment; once or twice daily) regularly for four weeks to stabilise their condition. The patients whose disease was brought under control then continued into a 16 week maintenance phase, applying emollient on a daily basis with a bath oil as needed and either the same formulation of fluticasone propionate or its placebo base (emollient alone) twice weekly to the areas that were usually affected. Main outcome measure Time to relapse of atopic dermatitis during maintenance phase. Results 376 patients entered the stabilisation phase, and 295 continued into the maintenance phase. After 16 weeks in the maintenance phase, the disease remained under control in 133 patients (87 using fluticasone propionate twice weekly, 46 using emollient alone), 135 (40 fluticasone propionate, 95 emollient) had experienced a relapse, and 27 had discontinued. Median time to relapse was six weeks for emollient alone compared with more than 16 weeks for additional fluticasone propionate. Patients who applied fluticasone propionate cream twice weekly were 5.8 times less likely (95% confidence interval 3.1 to 10.8, P < 0.001) and patients using fluticasone propionate ointment 1.9 times less likely (1.2 to 3.2, P=0.010) to have a relapse than patients applying emollient alone. The groups showed no differences in adverse events. Conclusion After atopic dermatitis had been stabilised the addition of fluticasone propionate twice weekly to maintenance treatment with emollients significantly reduced the risk of relapse.
  • Editor: London: British Medical Journal Publishing Group
  • Idioma: Inglês
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