Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus: A Multicenter, Double-Blind, Randomized, Parallel-Group Trial

Arthritis and Rheumatology

Volumn 69, Issue 4, 2017, Pages 791-799

  Yokogawa, N ^a   Eto, H ^b   Tanikawa, A ^c   Ikeda, T ^d   Yamamoto, K ^e   Takahashi, T ^f   Mizukami, H ^f   Sato, T ^f   Yokota, N ^f   Furukawa, F ^d  

^a TOKYO METROPOLITAN TAMA MEDICAL CENTER   (Japan)

^b ST LUKE'S INTERNATIONAL HOSPITAL   (Japan)

^c KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d WAKAYAMA MEDICAL UNIVERSITY   (Japan)

^e UNIVERSITY OF TOKYO   (Japan)

^f Sanofi KK ^*  (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

HYDROXYCHLOROQUINE; PLACEBO; ANTIMALARIAL AGENT;

ADULT; ARTICLE; CELLULITIS; CHORIORETINOPATHY; CONJUNCTIVITIS; CONTROLLED STUDY; CUTANEOUS LUPUS ERYTHEMATOSUS DISEASE AREA AND SEVERITY INDEX; DISCOID LUPUS ERYTHEMATOSUS; DISEASE EXACERBATION; DISEASE SEVERITY ASSESSMENT; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY EYE; EXPLORATORY RESEARCH; FATIGUE; FEMALE; HUMAN; JAPANESE (PEOPLE); LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PNEUMOCOCCAL MENINGITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RETINOPATHY; ROUTINE ASSESSMENT OF PATIENT INDEX DATA; SCORING SYSTEM; SIDE EFFECT; SKIN LUPUS ERYTHEMATOSUS; SKINDEX 29 SCORE; STEVENS JOHNSON SYNDROME; SYSTEMIC LUPUS ERYTHEMATOSUS; VITREOUS FLOATERS; CLINICAL TRIAL; JAPAN; LUPUS ERYTHEMATOSUS, CUTANEOUS; TREATMENT OUTCOME;

ADULT; ANTIMALARIALS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYDROXYCHLOROQUINE; JAPAN; LUPUS ERYTHEMATOSUS, CUTANEOUS; MALE; TREATMENT OUTCOME;

EID: 85016422519     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/art.40018     Document Type: Article

References (29)

1. Kuznik A, Bencina M, Svajger U, Jeras M, Rozman B, Jerala R. Mechanism of endosomal TLR inhibition by antimalarial drugs and imidazoquinolines. J Immunol 2011;186:4794–804.
2. The Canadian Hydroxychloroquine Study Group. A randomized study of the effect of withdrawing hydroxychloroquine sulfate in systemic lupus erythematosus. N Engl J Med 1991;324:150–4.
3. Tsakonas E, Joseph L, Esdaile JM, Choquette D, Senécal JL, Cividino A, et al. A long-term study of hydroxychloroquine withdrawal on exacerbations in systemic lupus erythematosus. Lupus 1998;7:80–5.
4. Fessler BJ, Alarcon GS, McGwin G Jr, Roseman J, Bastian HM, Friedman AW, et al. Systemic lupus erythematosus in three ethnic groups: XVI. Association of hydroxychloroquine use with reduced risk of damage accrual. Arthritis Rheum 2005;52:1473–80.
5. Pons-Estel GJ, Alarcon GS, McGwin G Jr, Danila MI, Zhang J, Bastian HM, et al. Protective effect of hydroxychloroquine on renal damage in patients with lupus nephritis: LXV, data from a multiethnic US cohort. Arthritis Rheum 2009;61:830–9.
6. Ruiz-Irastorza G, Egurbide MV, Pijoan JI, Garmendia M, Villar I, Martinez-Berriotxoa A, et al. Effect of antimalarials on thrombosis and survival in patients with systemic lupus erythematosus. Lupus 2006;15:577–83.
7. Jung H, Bobba R, Su J, Shariati-Sarabi Z, Gladman DD, Urowitz M, et al. The protective effect of antimalarial drugs on thrombovascular events in systemic lupus erythematosus. Arthritis Rheum 2010;62:863–8.
8. Ruiz-Irastorza G, Olivares N, Ruiz-Arruza I, Martinez-Berriotxoa A, Egurbide MV, Aguirre C. Predictors of major infections in systemic lupus erythematosus. Arthritis Res Ther 2009;11:R109.
9. Shinjo SK, Bonfa E, Wojdyla D, Borba EF, Ramirez LA, Scherbarth HR, et al. Antimalarial treatment may have a time-dependent effect on lupus survival: data from a multinational Latin American inception cohort. Arthritis Rheum 2010;62:855–62.
10. Alarcon GS, McGwin G, Bertoli AM, Fessler BJ, Calvo-Alén J, Bastian HM, et al. Effect of hydroxychloroquine on the survival of patients with systemic lupus erythematosus: data from LUMINA, a multiethnic US cohort (LUMINA L). Ann Rheum Dis 2007;66:1168–72.
11. Van Vollenhoven RF, Mosca M, Bertsias G, Isenberg D, Kuhn A, Lerstrøm K, et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis 2014;73:958–67.
12. Tebbe B, Orfanos CE. Epidemiology and socioeconomic impact of skin disease in lupus erythematosus. Lupus 1997;6:96–104.
13. Sigges J, Biazar C, Landmann A, Ruland V, Patsinakidis N, Amler S, et al. Therapeutic strategies evaluated by the European Society of Cutaneous Lupus Erythematosus (EUSCLE) core set questionnaire in more than 1000 patients with cutaneous lupus erythematosus. Autoimmun Rev 2013;12:694–702.
14. Ogawa S, Kurumatani N, Shibaike N, Yamazoe S. Progression of retinopathy long after cessation of chloroquine therapy. Lancet 1979;1:1408.
15. Kishimoto M, Deshpande GA, Yokogawa N, Buyon JP, Okada M. Use of hydroxychloroquine in Japan. J Rheumatol 2012;39:1296.
16. Albrecht J, Taylor L, Berlin JA, Dulay S, Ang G, Fakharzadeh S, et al. The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index): an outcome instrument for cutaneous lupus erythematosus. J Invest Dermatol 2005;125:889–94.
17. Yokogawa N, Tanikawa A, Amagai M, Kato Y, Momose Y, Arai S, et al. Response to hydroxychloroquine in Japanese patients with lupus-related skin disease using the cutaneous lupus erythematosus disease area and severity index (CLASI). Mod Rheumatol 2013;23:318–22.
18. Klein R, Moghadam-Kia S, LoMonico J, Okawa J, Coley C, Taylor L, et al. Development of the CLASI as a tool to measure disease severity and responsiveness to therapy in cutaneous lupus erythematosus. Arch Dermatol 2011;147:203–8.
19. Chren MM, Lasek RJ, Quinn LM, Mostow EN, Zyzanski SJ. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol 1996;107:707–13.
20. Pincus T, Yazici Y, Bergman M, Maclean R, Harrington T. A proposed continuous quality improvement approach to assessment and management of patients with rheumatoid arthritis without formal joint counts, based on quantitative Routine Assessment of Patient Index Data (RAPID) scores on a Multidimensional Health Assessment Questionnaire (MDHAQ). Best Pract Res Clin Rheumatol 2007;21:789–804.
21. Askanase AD, Castrejon I, Pincus T. Quantitative data for care of patients with systemic lupus erythematosus in usual clinical settings: a patient multidimensional health assessment questionnaire and physician estimate of noninflammatory symptoms. J Rheumatol 2011;38:1309–16.
22. Castrejon I, Tani C, Jolly M, Huang A, Mosca M. Indices to assess patients with systemic lupus erythematosus in clinical trials, long-term observational studies, and clinical care. Clin Exp Rheumatol 2014;32 Suppl 85:85–95.
23. Yee CS, Farewell V, Isenberg DA, Prabu A, Sokoll K, Teh LS, et al. Revised British Isles Lupus Assessment Group 2004 index: a reliable tool for assessment of systemic lupus erythematosus activity. Arthritis Rheum 2006;54:3300–5.
24. Chang AY, Piette EW, Foering KP, Tenhave TR, Okawa J, Werth VP. Response to antimalarial agents in cutaneous lupus erythematosus: a prospective analysis. Arch Dermatol 2011;147:1261–7.
25. Hochberg MC, for the Diagnostic and Therapeutic Criteria Committee of the American College of Rheumatology. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus [letter]. Arthritis Rheum 1997;40:1725.
26. Khamashta M, Merrill JT, Werth VP, Furie R, Kalunian K, Illei GG, et al. Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann Rheum Dis 2016;75:1909–16.
27. Williams HJ, Egger MJ, Singer JZ, Willkens RF, Kalunian KC, Clegg DO, et al. Comparison of hydroxychloroquine and placebo in the treatment of the arthropathy of mild systemic lupus erythematosus. J Rheumatol 1994;21:1457–62.
28. Gottenberg JE, Ravaud P, Puechal X, le Guern V, Sibilia J, Goeb V, et al. Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial. JAMA 2014;312:249–58.
29. Morita S, Takahashi T, Yoshida Y, Yokota N. Population pharmacokinetics of hydroxychloroquine in Japanese patients with cutaneous or systemic lupus erythematosus. Ther Drug Monit 2016;38:259–67.