Acta Dermato-Venereologica 99-12CompleteContent | Page 10

1078 CLINICAL REPORT Efficacy and Safety of Oral Administration of a Mixture of Probiotic Strains in Patients with Psoriasis: A Randomized Controlled Clinical Trial Vicente NAVARRO-LÓPEZ 1,2 , Asunción MARTÍNEZ-ANDRÉS 2,3 , Ana RAMÍREZ-BOSCÀ 2,3 , Beatriz RUZAFA-COSTAS 2 , Eva NÚÑEZ-DELEGIDO 2 , Miguel A. CARRIÓN-GUTIÉRREZ 2 , David PRIETO-MERINO 4,5 , Francisco CODOÑER-CORTÉS 6 , Daniel RAMÓN-VIDAL 7 , Salvador GENOVÉS-MARTÍNEZ 7 , Empar CHENOLL-CUADROS 7 , José M. PÉREZ-ORQUÍN 8 , Jose A. PICÓ- MONLLOR 8,9 and Sara CHUMILLAS-LIDÓN 2 1 Clinical Microbiology and Infectious Disease Unit, Hospital Universitario Vinalopó, Elche, 2 Department of Clinical Medicine, MiBioPath Research Group, Universidad Católica San Antonio de Murcia (UCAM), Murcia, 3 Department of Dermatology, Centro Dermatológico Estético de Alicante, Alicante, 4 Applied Statistical Methods in Medical Research Group, Universidad Católica San Antonio de Murcia (UCAM), Murcia, Spain, 5 Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK, 6 ADM Lifesequencing S.L., Paterna, 7 ADM Biopolis, Paterna, Valencia, 8 Health Coach S.L., Alcoy, Alicante, and 9 Department of Pharmacy, Universidad Miguel Hernández de Elche, Elche, Spain The aim of this 12-week randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of a probiotic mixture in the reduction of psoriasis severity. Ninety 18–70-year-old adults with plaque psoriasis were randomized into probiotic and placebo groups. At 12-week follow-up, 66.7% of pa- tients in the probiotic group and 41.9% in the placebo group showed a reduction in Psoriasis Area and Seve- rity Index of up to 75% (p  < 0.05). A clinically relevant difference was observed in Physician Global Assess- ment index: 48.9% in the probiotic group achieved a score of 0 or 1, compared with 30.2% in the placebo group. The results of follow-up 6 months after the end of the study showed a lower risk of relapse after the intake of the probiotic mixture. Analysis of gut micro- biota confirmed the efficacy of the probiotic in modula- tion of the microbiota composition. Key words: psoriasis; dermatology; probiotic; microbiome; microbiota. Accepted Aug 26, 2019; E-published Aug 27, 2019 Acta Derm Venereol 2019: 99: 1078–1084. Corr: Vicente Navarro López, MiBioPath Research Group. Universidad Católica San Antonio de Murcia (UCAM). Av. de los Jerónimos, 135, ES- 30107 Guadalupe, Murcia, Spain. E-mail: [email protected], vicente. [email protected] P soriasis is traditionally defined as an immune-med- iated, inflammatory dermatological disease charac­ terized by a chronic-relapsing course and associated with multifactorial inheritance. Until recently psoriasis was considered to be a dermatological disease only, but is currently defined as a systemic one because of the involvement of multiple organs with important impact on social life and relationships (1). Social, psychological and economic impacts are comparable to other chronic diseases, such as chronic bronchitis, diabetes mellitus or depression (2). The disease affects 0.09–11.4% of the population worldwide, with variability between different countries (2). doi: 10.2340/00015555-3305 Acta Derm Venereol 2019; 99: 1078–1084 SIGNIFICANCE This clinical trial evaluated the effect of a probiotic mixture as coadjutant treatment together with topical steroids in 90 patients with plaque psoriasis. The results showed a larger reduction in the score of severity indexes in the probiotic group compared with the placebo group. Gut microbiota analysis demonstrated the efficacy of the probiotic in mo- dulation of the composition of the microbiota. After the end of the probiotic or placebo intake, patients were followed- up for 6 months. The results showed a lower risk of relapse in patients in the probiotic group. The pathogenesis of psoriasis can be explained by dysregulation of immunological cell function, as well as keratinocyte proliferation/differentiation. Recently, the immunological pathomechanism has been substantially clarified (3). The elevation of inflammatory markers, such as tumour necrosis factor (TNF)-α, interleukin (IL)-12, IL-23 and IL-17, is characteristic in peripheral blood of patients with psoriasis (4). Treatment has been based for years on the use of topical or systemic immunosuppres- sants, such as systemic corticosteroids, methotrexate or cyclosporine, or phototherapy (narrow-band ultraviolet B (UVB) phototherapy, broad-band UVB or psoralen- UVA photochemotherapy) (5). In recent years, there has been marked progress in treatment of the disease due to development of drugs such as anti-TNF-α, and anti-interleukin (IL)-23 and anti-IL-17 monoclonal anti- bodies (6, 7). These drugs are generally more effective than topical or systemic immunosuppressants; however, there is a high economic cost and, rarely, they may cause severe side-effects, such as emergence of latent infectious diseases, such as tuberculosis or hepatitis B, which required complex treatment (7, 8). In addition, after some time, in a few cases antibodies are produced against these drugs, decreasing their effectiveness (9). Recent findings demonstrate the presence of bacterial DNA (bactDNA) in peripheral blood samples from pa- This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2019 Acta Dermato-Venereologica.