Cited by 67Systemic Lupus Erythematosus ResearchBlood Coagulation and Thrombosis MechanismsVenous Thromboembolism Diagnosis and Management

Hydroxychloroquine in the primary thrombosis prophylaxis of antiphospholipid antibody positive patients without systemic autoimmune disease

Erkan, D, Unlu, O, Sciascia, S, Belmont, H M, Branch, D Ware, Cuadrado, M J, Gonzalez, E, Knight, J S +6 more·2018·Lupus

Abstract

Objective: The objective of this study was to determine the efficacy of hydroxychloroquine (HCQ) in the primary thrombosis prevention of antiphospholipid antibody (aPL)-positive patients with no other systemic autoimmune diseases. Methods: Under the auspices of Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking, a multicenter, international, randomized controlled trial (RCT) was initiated, in which persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases were randomized to receive HCQ or no treatment in addition to their standard regimen. The primary objective was the efficacy of HCQ in preventing the first thrombosis. The secondary objectives were the thrombosis incidence rate, and the effects of HCQ on aPL profile and mortality rate. Patients were risk-stratified based on antiplatelet agent use. The goal was to follow patients every 6 months for 5 years. Results: We recruited 20 persistently aPL-positive patients (female: 19, mean age: 46.6 ± 9.9 years, and baseline antiplatelet medication: 14); 9/20 were randomized to HCQ. During the mean follow-up of 1.7 years, no patients developed thrombosis or a serious adverse event. The study was terminated early due to the low recruitment rate, exacerbated by the prolonged manufacturing shortage and significant price increase of HCQ in the United States. Conclusion: Given that a small number of patients with a relatively short follow-up were enrolled in our RCT, and no patients developed thrombosis, we cannot accurately assess the effectiveness of HCQ for primary thrombosis prevention in persistently aPL-positive patients with no other systemic autoimmune diseases. Our experience suggests that conducting an international RCT, especially without pharmaceutical support, is an extremely challenging undertaking.

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Crossref · 10.1177/0961203317724219

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1 of the 33 references couldn’t be matched to a known paper.

Research works printed but not linked: 4

  1. Giron-Gonzalez JA, 2004, J Rheumatol, 31, 1560
  2. Somers E, 2002, J Rheumatol, 29, 2531
  3. Silver RM, 1994, Obstet Gynecol, 83, 372
  4. Guyatt G, Drummond R, Meade M, Cook D. The evidence-based medicine working group. In: Users’ guides to the medical literature. Essentials of evidence-based clinical practice . Chicago, IL: McGraw Hill Education, 2008.

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Authors
Erkan, D., Unlu, O., Sciascia, S., Belmont, H. M., Branch, D. W., Cuadrado, M. J., Gonzalez, E., Knight, J. S., Uthman, I., Willis, R., Zhang, Z., Wahl, D., Zuily, S., & Tektonidou, M. G.
Affiliations
  • Hospital for Special Surgery (US)
  • Ospedale San Giovanni Bosco (IT)
  • NYU Langone Health (US)
  • University of Utah (US)
  • St Thomas' Hospital (GB)
  • The University of Texas Medical Branch at Galveston (US)
  • University of Michigan (US)
  • American University of Beirut (LB)
  • Peking University First Hospital (CN)
  • Centre Hospitalier Régional et Universitaire de Nancy (FR)
  • National and Kapodistrian University of Athens (GR)
Venue
Lupus
Published
2017-08-01
Volume
27
Issue
3
Pages
399-406
ISSN
  • 0961-2033 (ISSN-L)
  • 1477-0962
OpenAlex
W2741035577
Cited by
67
References
33
Citations by year
2026: 2 · 2025: 3 · 2024: 5 · 2023: 7 · 2022: 4 · 2021: 9 · 2020: 14 · 2019: 8 · 2018: 14
FWCI
7.56
Type
journal article
Language
en
Open access
closed
Locations
  • Lupus (publishedVersion)
  • PubMed (publishedVersion)
  • Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
Topics
  • Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
  • Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
  • Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Keywords
hydroxychloroquine, antiphospholipid antibodies, antiphospholipid syndrome, antiplatelet therapy, drug shortages, mortality
MeSH terms
Adult, Blood Platelets, Erythrocytes, Female, Humans, Hydroxychloroquine, Male, Middle Aged, New York

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