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Introduction What’s already known?

Relapse of porphyria cutanea tarda after treatment with phlebotomy or 4-aminoquinoline antimalarials: A Meta-analysis. Habeeb Salameh 1 , Hamzeh Sarairah 2 , Maira Rizwan 3 , Yong-Fang Kuo, 4 Karl E. Anderson KE 1,4 , Ashwani K. Singal 3

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Introduction What’s already known?

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  1. Relapse of porphyria cutanea tarda after treatment with phlebotomy or 4-aminoquinoline antimalarials: A Meta-analysis Habeeb Salameh1, Hamzeh Sarairah2, Maira Rizwan3, Yong-Fang Kuo,4 Karl E. Anderson KE1,4, Ashwani K. Singal3 1Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas 2Department of Internal Medicine, University of Texas Medical Branch, Galveston, Texas 3Division of Gastroenterology and Hepatology, University of Alabama, Birmingham, Alabama 4Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston, Texas British Journal of Dermatology. DOI: 10.111/bjd.16741

  2. Introduction What’s already known? • Porphyria cutaneatarda is a chronic disease with potential for relapses and remissions. • Porphyria cutaneatarda is readily treatable with 4-aminoquinolines or repeated phlebotomy.

  3. Objective • The primary outcome: • pooled relapse rate of Porphyria CutaneaTarda after achieving remission with either repeated phlebotomy or 4-aminoquinolines.

  4. Methods (1) • Study followed the MOOSE (Meta-analysis of Observational Studies in Epidemiology) guidelines. • Search engines Pubmed, Embase, Scopus, CINAHL, and Cochrane databases were queried for the following initial medical subject headings (MeSH) search terms: • “porphyria cutanea tarda”, “phlebotomy”, “4-aminoquinoline”, “chloroquine” and “hydroxychloroquine” • All databases searched through December 2017.

  5. Methods (2) • Eligible studies fulfilled the following criteria: • study population of PCT patients was treated with either phlebotomy or 4-aminoquinolines • reported data on relapse of PCT after achieving remission • defined relapse as biochemical (elevation of plasma and/or urine porphyrins) or clinical (appearance of skin lesions) • median follow up period of at least one year • Three authors reviewed citations for inclusion and two authors extracted data. • MINORS (Methodological Index for Nonrandomized Studies) statement used for quality assessment.

  6. Methods (3) • A random effects model was used for analyzing pooled data for all the analyses. • Heterogeneity analysis was done. • All statistical analyses were performed using the Comprehensive Meta-analysis program (Biostat, Englewood, NJ).

  7. Methods (4) • Poisson distribution approach was used to analyze pooled relapse rates. • Median follow up was weighted for sample size in each study to calculate the person years of follow up in each study. • Assumption was made that each patient in the study was followed for the median follow up time. • Relapse rate for individual studies was calculated by dividing the number of relapses by follow-up person years (95% confidence interval).

  8. Results (1): Attrition diagram

  9. Results (2): Baseline characteristics

  10. Results (3): Pooled relapse rate per 100 person-years follow up

  11. Results (4): Pooled relapse rate per 100 person-years follow up Pooled relapse rates (RR) with their 95% confidence intervals (CI) were • 8.6 (3.9-13.3) per 100 person-years in the high dose 4-aminoquinoline group • 17.1 (8.9-25.3) per 100 person-years in the low dose 4-aminoquinoline group • 5.1 (0.5-10.6) per 100 person-years in the phlebotomy group. Subgroup and sensitivity analyses showed similar results.

  12. Discussion (1) • Similar efficacy of phlebotomy and a 4-aminoquinoline regimen in terms of rates of remission, but some patients relapse after either treatment. • Low dose 4-aminoquinoline regimen replaced high dose regimen due to side effects. • Pooled relapse rate (RR) of PCT per 100 person-years was somewhat higher after achieving remission with low dose 4-aminoquinolines compared to high dose 4-aminoquinolines or repeated phlebotomy regimen.

  13. Discussion (2): Limitations • Possibility of publication bias • Inclusion of case control studies • Short median follow-up • Heterogeneity of the included studies • Lack of information on susceptibility factors status after remission of PCT

  14. Conclusions: What does this study add? • Relapse rate of PCT (5-17 per 100 person years) justify at least annual follow up after remission. • Relapse is somewhat higher after initial treatment with low dose 4-aminoquinolines. • Studies are needed for developing homogeneous prospective long-term follow up data to overcome limitations in this analysis. • Ongoing longitudinal study in the porphyria consortium will hopefully provide such data on relapse of PCT after remission.

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