Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus
Autor(a) principal: | |
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Data de Publicação: | 2005 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNIFESP |
Texto Completo: | http://repositorio.unifesp.br/handle/11600/28472 http://dx.doi.org/10.1002/art.21358 |
Resumo: | Objective. To evaluate the efficacy of clofazimine (CFZ) compared with chloroquine diphosphate (CDP) for the treatment of cutaneous involvement in systemic lupus erythematosus (SLE).Methods. A prospective, randomized, controlled, double-blind clinical trial was carried out in SLE patients with active cutaneous lesions, of whom 16 were randomized to receive CFZ at 100 mg/day and 17 received CDP at 250 mg/day for 6 months. All drugs had a similar appearance to avoid identification. Both groups received broad-spectrum sunscreens twice a day and the prednisone dose was kept stable during the study. Cutaneous lesions were evaluated by 2 blinded observers at baseline and at months 1, 2, 4, and 6.Results. Thirty-three patients were randomized to a treatment group, of whom 27 completed 6 months of treatment. the groups were homogeneous and comparable in terms of demographic and clinical characteristics. Five CFZ-treated patients and 1 CDP-treated patient (P = 0.15) dropped out due to development of severe lupus flare. At the end of the study, 12 CFZ-treated patients (75%) and 14 CDP-treated patients (82.4%) had complete or near-complete remission of skin lesions; intention-to-treat analysis showed no significant difference in the response rates between groups. Side effects, mainly skin and gastrointestinal events, were frequent in both groups, but no patients had to discontinue their treatment.Conclusion. These findings suggest that CFZ is equally as effective as CDP in controlling cutaneous lesions in SLE patients. However, we cannot exclude the possibility that the CFZ itself could be the cause of systemic lupus flare. |
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Bezerra, ELMVilar, MJPNeto, PBDSato, Emilia Inoue [UNIFESP]Univ Fed Rio Grande NorteUniversidade Federal de São Paulo (UNIFESP)2016-01-24T12:38:04Z2016-01-24T12:38:04Z2005-10-01Arthritis and Rheumatism. Hoboken: Wiley-liss, v. 52, n. 10, p. 3073-3078, 2005.0004-3591http://repositorio.unifesp.br/handle/11600/28472http://dx.doi.org/10.1002/art.2135810.1002/art.21358WOS:000232548800016Objective. To evaluate the efficacy of clofazimine (CFZ) compared with chloroquine diphosphate (CDP) for the treatment of cutaneous involvement in systemic lupus erythematosus (SLE).Methods. A prospective, randomized, controlled, double-blind clinical trial was carried out in SLE patients with active cutaneous lesions, of whom 16 were randomized to receive CFZ at 100 mg/day and 17 received CDP at 250 mg/day for 6 months. All drugs had a similar appearance to avoid identification. Both groups received broad-spectrum sunscreens twice a day and the prednisone dose was kept stable during the study. Cutaneous lesions were evaluated by 2 blinded observers at baseline and at months 1, 2, 4, and 6.Results. Thirty-three patients were randomized to a treatment group, of whom 27 completed 6 months of treatment. the groups were homogeneous and comparable in terms of demographic and clinical characteristics. Five CFZ-treated patients and 1 CDP-treated patient (P = 0.15) dropped out due to development of severe lupus flare. At the end of the study, 12 CFZ-treated patients (75%) and 14 CDP-treated patients (82.4%) had complete or near-complete remission of skin lesions; intention-to-treat analysis showed no significant difference in the response rates between groups. Side effects, mainly skin and gastrointestinal events, were frequent in both groups, but no patients had to discontinue their treatment.Conclusion. These findings suggest that CFZ is equally as effective as CDP in controlling cutaneous lesions in SLE patients. However, we cannot exclude the possibility that the CFZ itself could be the cause of systemic lupus flare.Univ Fed Rio Grande Norte, BR-59014020 Natal, RN, BrazilUniversidade Federal de São Paulo, São Paulo, BrazilUniversidade Federal de São Paulo, EPM, São Paulo, BrazilWeb of Science3073-3078engWiley-BlackwellArthritis and Rheumatismhttp://olabout.wiley.com/WileyCDA/Section/id-406071.htmlinfo:eu-repo/semantics/openAccessDouble-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosusinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlereponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP11600/284722022-09-27 14:37:30.934metadata only accessoai:repositorio.unifesp.br:11600/28472Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestopendoar:34652022-09-27T17:37:30Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false |
dc.title.en.fl_str_mv |
Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus |
title |
Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus |
spellingShingle |
Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus Bezerra, ELM |
title_short |
Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus |
title_full |
Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus |
title_fullStr |
Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus |
title_full_unstemmed |
Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus |
title_sort |
Double-blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus |
author |
Bezerra, ELM |
author_facet |
Bezerra, ELM Vilar, MJP Neto, PBD Sato, Emilia Inoue [UNIFESP] |
author_role |
author |
author2 |
Vilar, MJP Neto, PBD Sato, Emilia Inoue [UNIFESP] |
author2_role |
author author author |
dc.contributor.institution.none.fl_str_mv |
Univ Fed Rio Grande Norte Universidade Federal de São Paulo (UNIFESP) |
dc.contributor.author.fl_str_mv |
Bezerra, ELM Vilar, MJP Neto, PBD Sato, Emilia Inoue [UNIFESP] |
description |
Objective. To evaluate the efficacy of clofazimine (CFZ) compared with chloroquine diphosphate (CDP) for the treatment of cutaneous involvement in systemic lupus erythematosus (SLE).Methods. A prospective, randomized, controlled, double-blind clinical trial was carried out in SLE patients with active cutaneous lesions, of whom 16 were randomized to receive CFZ at 100 mg/day and 17 received CDP at 250 mg/day for 6 months. All drugs had a similar appearance to avoid identification. Both groups received broad-spectrum sunscreens twice a day and the prednisone dose was kept stable during the study. Cutaneous lesions were evaluated by 2 blinded observers at baseline and at months 1, 2, 4, and 6.Results. Thirty-three patients were randomized to a treatment group, of whom 27 completed 6 months of treatment. the groups were homogeneous and comparable in terms of demographic and clinical characteristics. Five CFZ-treated patients and 1 CDP-treated patient (P = 0.15) dropped out due to development of severe lupus flare. At the end of the study, 12 CFZ-treated patients (75%) and 14 CDP-treated patients (82.4%) had complete or near-complete remission of skin lesions; intention-to-treat analysis showed no significant difference in the response rates between groups. Side effects, mainly skin and gastrointestinal events, were frequent in both groups, but no patients had to discontinue their treatment.Conclusion. These findings suggest that CFZ is equally as effective as CDP in controlling cutaneous lesions in SLE patients. However, we cannot exclude the possibility that the CFZ itself could be the cause of systemic lupus flare. |
publishDate |
2005 |
dc.date.issued.fl_str_mv |
2005-10-01 |
dc.date.accessioned.fl_str_mv |
2016-01-24T12:38:04Z |
dc.date.available.fl_str_mv |
2016-01-24T12:38:04Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
Arthritis and Rheumatism. Hoboken: Wiley-liss, v. 52, n. 10, p. 3073-3078, 2005. |
dc.identifier.uri.fl_str_mv |
http://repositorio.unifesp.br/handle/11600/28472 http://dx.doi.org/10.1002/art.21358 |
dc.identifier.issn.none.fl_str_mv |
0004-3591 |
dc.identifier.doi.none.fl_str_mv |
10.1002/art.21358 |
dc.identifier.wos.none.fl_str_mv |
WOS:000232548800016 |
identifier_str_mv |
Arthritis and Rheumatism. Hoboken: Wiley-liss, v. 52, n. 10, p. 3073-3078, 2005. 0004-3591 10.1002/art.21358 WOS:000232548800016 |
url |
http://repositorio.unifesp.br/handle/11600/28472 http://dx.doi.org/10.1002/art.21358 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.ispartof.none.fl_str_mv |
Arthritis and Rheumatism |
dc.rights.driver.fl_str_mv |
http://olabout.wiley.com/WileyCDA/Section/id-406071.html info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
http://olabout.wiley.com/WileyCDA/Section/id-406071.html |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
3073-3078 |
dc.publisher.none.fl_str_mv |
Wiley-Blackwell |
publisher.none.fl_str_mv |
Wiley-Blackwell |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UNIFESP instname:Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP |
instname_str |
Universidade Federal de São Paulo (UNIFESP) |
instacron_str |
UNIFESP |
institution |
UNIFESP |
reponame_str |
Repositório Institucional da UNIFESP |
collection |
Repositório Institucional da UNIFESP |
repository.name.fl_str_mv |
Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP) |
repository.mail.fl_str_mv |
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1802764177353211904 |