Extracorporeal photopheresis for systemic sclerosis: A meta-analysis of randomized clinical trials.
meta-analysis
photopheresis
scleroderma
systematic review
systemic
systemic sclerosis
Journal
Dermatologic therapy
ISSN: 1529-8019
Titre abrégé: Dermatol Ther
Pays: United States
ID NLM: 9700070
Informations de publication
Date de publication:
07 2022
07 2022
Historique:
revised:
11
04
2022
received:
13
03
2022
accepted:
18
04
2022
pubmed:
22
4
2022
medline:
15
7
2022
entrez:
21
4
2022
Statut:
ppublish
Résumé
Systemic sclerosis (scleroderma) (SSc) is a rare autoimmune disorder characterized by excessive production of collagen. Extracorporeal photopheresis (photochemotherapy, phototherapy) (ECP) involves repeated exposure of peripheral blood lymphocytes to ultraviolet A (UVA) radiation. The rationale for treating patients with SSc by ECP lies in its presumed immunomodulatory effects, though, rigorous data on the specific effects of ECP are limited, particularly in patients with SSc. The objective was to evaluate the effects of extracorporeal photopheresis as a treatment modality for patients with SSc. We searched the databases CENTRAL and MEDLINE on 13 March 2022 and included randomized clinical trials (RCTs) on patients diagnosed with SSc and treated with ECP. Primary outcome was the change of skin scores. We applied independent extraction and judgment by multiple observers. We conducted a meta-analysis applying the inverse variance method and the random effects model; the main outcome measure was standard mean difference of skin scores. We identified three relevant RCTs including 162 randomized (132 analyzed) people who received ECP in a simple parallel design. Pooled data of the three studies were indifferent. We estimated a standard mean difference from baseline of -0.11 (95% confidence interval -0.45 to 0.23), p = 0.54, I
Types de publication
Journal Article
Meta-Analysis
Langues
eng
Sous-ensembles de citation
IM
Pagination
e15530Informations de copyright
© 2022 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC.
Références
Systemic scleroderma. Genetic and Rare Diseases Information Center (GARD). National Center for Advancing Translational Sciences https://rarediseases.info.nih.gov/diseases/9748/systemic-scleroderma. Accessed 13 March 2022
Scleroderma. Mayo Foundation for Medical Education and Research (MFMER). https://www.mayoclinic.org/diseases-conditions/scleroderma/symptoms-causes/syc-20351952. Accessed 13 March 2022
Scleroderma. National Health System (NHS). https://www.nhs.uk/conditions/scleroderma/. Accessed 13 March 2022
van den Hoogen F, Khanna D, Fransen J, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European league against rheumatism collaborative initiative. Arthritis Rheum. 2013;65(11):2737-2747.
Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003;9(4):215-233.
LeRoy EC, Black C, Fleischmajer R, et al. Scleroderma (systemic sclerosis): classification, subsets and pathogenesis. J Rheumatol. 1988;15(2):202-205.
Johnson SR, van den Hoogen F, Devakandan K, Matucci-Cerinic M, Pope JE. Systemic sclerosis: to subset or not to subset, that is the question. Eur J Rheumatol. 2020;7(Suppl. 3):S222-S227.
Bergamasco A, Hartmann N, Wallace L, Verpillat P. Epidemiology of systemic sclerosis and systemic sclerosis-associated interstitial lung disease. Clin Epidemiol. 2019;11:257-273.
Scleroderma. Orphanet. The portal for rare diseases and orphan drugs. https://www.orpha.net/consor/cgi-bin/OC_Exp.php?lng=EN&Expert=801. Accessed 13 March 2022
Knobler R, Arenberger P, Arun A, et al. European dermatology forum: updated guidelines on the use of extracorporeal photopheresis 2020 - part 2. J Eur Acad Dermatol Venereol. 2021;35(1):27-49.
Du AX, Osman M, Gniadecki R. Use of extracorporeal photopheresis in scleroderma: a review. Dermatology. 2020;236(2):105-110.
Barnett AJ, Miller MH, Littlejohn GO. A survival study of patients with scleroderma diagnosed over 30 years (1953-1983): the value of a simple cutaneous classification in the early stages of the disease. J Rheumatol. 1988;15(2):276-283.
Enomoto DN, Mekkes JR, Bossuyt PM, et al. Treatment of patients with systemic sclerosis with extracorporeal photochemotherapy (photopheresis). J Am Acad Dermatol. 1999;41(6):915-922.
Knobler RM, French LE, Kim Y, et al. A randomized, double-blind, placebo-controlled trial of photopheresis in systemic sclerosis. J Am Acad Dermatol. 2006;54(5):793-799.
Rook AH, Freundlich B, Jegasothy BV, et al. Treatment of systemic sclerosis with extracorporeal photochemotherapy. Results of a multicenter trial. Arch Dermatol. 1992;128(3):337-346.
Edelson R, Berger C, Gasparro F, et al. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy. Preliminary results. N Engl J Med. 1987;316(6):297-303.
Bladon J, Taylor PC. Extracorporeal photopheresis: a focus on apoptosis and cytokines. J Dermatol Sci. 2006;43(2):85-94.
Rodnan GP, Lipinski E, Luksick J. Skin thickness and collagen content in progressive systemic sclerosis and localized scleroderma. Arthritis Rheum. 1979;22(2):130-140.
Khanna D, Furst DE, Clements PJ, et al. Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis. J Scleroderma Relat Disord. 2017;2(1):11-18.
Kahaleh MB, Sultany GL, Smith EA, Huffstutter JE, Loadholt CB, LeRoy EC. A modified scleroderma skin scoring method. Clin Exp Rheumatol. 1986;4(4):367-369.
Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.
Review Manager (RevMan) [Computer program]. Version 5.3. Copenhagen: The Nordic Cochrane Centre, 2014
Higgins JPT, Deeks JJ, Altman DG. Chapter 16: special topics in statistics. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (Updated March 2011). Cochrane; 2011 https://handbook-5-1.cochrane.org/chapter_16/16_1_3_2_imputing_standard_deviations_for_changes_from_baseline.htm. Accessed 13 March 2022
Higgins JPT, Deeks JJ. Chapter 7: selecting studies and collecting data. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (Updated March 2011). Cochrane; 2011 https://handbook-5-1.cochrane.org/chapter_7/7_7_3_3_obtaining_standard_deviations_from_standard_errors.htm. Accessed 13 March 2022
Deeks JJ, Higins JPT, Altman DG. Chapter 9: Analysing data and undertaking meta-analyses. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). Cochrane; 2011 https://handbook-5-1.cochrane.org/chapter_9/9_2_3_2_the_standardized_mean_difference.htm. Accessed 13 March 2022
Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327(7414):557-560.
Higgins JPT, Altman DG, Sterne JA. Chapter 8: assessing risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (Updated March 2011). Cochrane; 2011.
Adams LB, Park JH, Olsen NJ, Gardner ES, Hernanz-Schulman M, King LE Jr. Quantitative evaluation of improvement in muscle weakness in a patient receiving extracorporeal photopheresis for scleroderma: magnetic resonance imaging and magnetic resonance spectroscopy. J Am Acad Dermatol. 1995;33(3):519-522.
Cribier B, Faradji T, Le Coz C, Oberling F, Grosshans E. Extracorporeal photochemotherapy in systemic sclerosis and severe morphea. Dermatology. 1995;191(1):25-31.
Dall'Amico R, Zulian F, Montini G, et al. Applications of extracorporeal photochemotherapy in “non-oncological” diseases. Int J Artif Organs. 1993;16(Suppl. 5):168-172.
Di Spaltro FX, Cottrill C, Cahill C, et al. Extracorporeal photochemotherapy in progressive systemic sclerosis. Int J Dermatol. 1993;32(6):417-421.
Fimiani M, Rubegni P, Flori ML, Mazzatenta C, D'Ascenzo G, Andreassi L. Three cases of progressive systemic sclerosis treated with extracorporeal photochemotherapy. Arch Dermatol Res. 1997;289(2):120-122.
French LE, Lessin SR, Addya K, et al. Identification of clonal T cells in the blood of patients with systemic sclerosis: positive correlation with response to photopheresis. Arch Dermatol. 2001;137(10):1309-1313.
Gambichler T, Özsoy O, Bui D, Scheel CH, Susok L. Preliminary results on long-term follow-up of systemic sclerosis patients under extracorporeal photopheresis. J Dermatolog Treat. 2021;29:1-4.
Hashikabe M, Ohtsuka T, Yamazaki S. Quantitative echographic analysis of photochemotherapy on systemic sclerosis skin. Arch Dermatol Res. 2005;296(11):522-527.
Krasagakis K, Dippel E, Ramaker J, Owsianowski M, Orfanos CE. Management of severe scleroderma with long-term extracorporeal photopheresis. Dermatology. 1998;196(3):309-315.
Muellegger RR, Hofer A, Salmhofer W, Soyer HP, Kerl H, Wolf P. Extended extracorporeal photochemotherapy with extracorporeal administration of 8-methoxypsoralen in systemic sclerosis. An Austrian single-center study. Photodermatol Photoimmunol Photomed. 2000;16(5):216-223.
Owsianowski M, Garbe C, Ramaker J, Orfanos CE, Gollnick H. Therapeutic experiences with extracorporeal photopheresis. Technical procedure, follow-up and clinical outcome in 31 skin diseases. Hautarzt. 1996;47(2):114-123.
Papp G, Horvath IF, Barath S, et al. Immunomodulatory effects of extracorporeal photochemotherapy in systemic sclerosis. Clin Immunol. 2012;142(2):150-159.
Papp G, Horvath IF, Gyimesi E, et al. The assessment of immune-regulatory effects of extracorporeal photopheresis in systemic sclerosis: a long-term follow-up study. Immunol Res. 2016;64(2):404-411.
Reich S, Gambichler T, Altmeyer P, Kreuter A. Extracorporeal photopheresis in systemic sclerosis: effects on organ involvement? J Am Acad Dermatol. 2007;56(2):348-349.
Reich S, Radenhausen M, Altmeyer P, Hoffmann K. Extracorporeal photopheresis in progressive systemic sclerosis: discrimination of responders and non-responders. J Dtsch Dermatol Ges. 2003;1(12):945-951.
Rook AH, Freundlich B, Nahass GT, et al. Treatment of autoimmune disease with extracorporeal photochemotherapy: progressive systemic sclerosis. Yale J Biol Med. 1989;62(6):639-645.
Schwartz J, Gonzalez J, Palangio M, Klainer AS, Bisaccia E. Extracorporeal photochemotherapy in progressive systemic sclerosis: a follow-up study. Int J Dermatol. 1997;36(5):380-385.
Wollina U, Oelzner S, Looks A, et al. Progressive systemic sclerosis - treatment results of extracorporeal photopheresis. Hautarzt. 1999;50(9):637-642.
Zachariae H, Bjerring P, Heickendorff L, Møller B, Wallevik K, Angelo H. Photopheresis in systemic sclerosis: clinical and serological studies using markers of collagen metabolism. Acta Derm Venereol. 1993;73(5):356-361.
NCT04986605. Extracorporeal photopheresis in early diffuse cutaneous systemic sclerosis. Last Update Posted: November 26, 2021. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04986605. Accessed 13 March 2022
Zhou XA, Choi J. Photopheresis: advances and use in systemic sclerosis. Curr Rheumatol Rep. 2017;19(6):31.
Ward DM. Extracorporeal photopheresis: how, when, and why. J Clin Apher. 2011;26(5):276-285.
AWMF-S2k-Leitlinie (013-072). Extrakorporale Photopherese (ECP). Stand: 27.01.2022 , gültig bis 26.01.2027. https://www.awmf.org/leitlinien/detail/ll/013-072.html. Accessed 13 March 2022
Nagendrababu V, Dilokthornsakul P, Jinatongthai P, et al. Glossary for systematic reviews and meta-analyses. Int Endod J. 2020;53(2):232-249.
Glossary of Terms in The Cochrane CollaborationVersion 4.2.5 Updated May 2005. http://aaz.hr/resources/pages/57/7.%20Cochrane%20glossary.pdf. Accessed 13 March 2022.
Ryan R, Hill S, Broclain D, Horey D, Oliver S, Prictor M. Study Design Guide. Cochrane Consumers and Communication Review Group; 2013 https://opal.latrobe.edu.au/articles/journal_contribution/Study_design_guide/6818900. Accessed 13 March 2022
Vandenbroucke JP. Prospective or retrospective: what's in a name? BMJ. 1991;302(6771):249-250.
Vandenbroucke JP, von Elm E, Altman DG, et al. Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration. PLoS Med. 2007;4(10):e297.
Lachin JM. Fallacies of last observation carried forward analyses. Clin Trials. 2016;13(2):161-168.
Guidance for Clinical Trial Sponsors. Establishment and Operation of Clinical Trial Data Monitoring Committees. U.S. Food and Drug Administration; 2006 https://www.fda.gov/media/75398/download. Accessed 13 March 2022
The early termination of clinical trials: causes, consequences, and control. With special reference to trials in the field of arrhythmias and sudden death. Task force of the working group on arrhythmias of the European Society of Cardiology. Circulation. 1994;89(6):2892-2907.
Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7(3):e1000251.