Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus

A Multicenter, Double-Blind, Randomized, Parallel-Group Trial

N. Yokogawa, H. Eto, Akiko Tanikawa, T. Ikeda, K. Yamamoto, T. Takahashi, H. Mizukami, T. Sato, N. Yokota, F. Furukawa

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Objective: To assess the efficacy and tolerability of hydroxychloroquine (HCQ) in patients with cutaneous lupus erythematosus (CLE), in a phase III clinical trial conducted in Japan. Methods: We conducted a double-blind, randomized, parallel-group clinical trial. This was a baseline-controlled study, and the group differences were evaluated in an exploratory analysis. A total of 103 patients with active CLE (according to a Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] activity score of ≥4) were included. Patients were randomized 3:1 to receive HCQ or placebo during the 16-week double-blind period, and all patients were given HCQ during the following 36-week single-blind period. The primary efficacy end point was a reduction in the CLASI activity score at week 16. The secondary end points included the central photo evaluation (5-point scale), patient's global assessment (7-point scale), the Skindex-29 score, and investigator's global assessment (7-point scale, based on the other 3 secondary end points). In patients with systemic lupus erythematosus, fatigue and musculoskeletal pain were assessed. Safety was assessed up to week 55. Results: The mean CLASI score at week 16 was significantly improved from baseline in both the HCQ group and the placebo group: mean change −4.6 (95% confidence interval [95% CI] −6.1, −3.1) (P < 0.0001), and mean change −3.2 (95% CI −5.1, −1.3) (P = 0.002), respectively, without between-group difference (P = 0.197). The investigator's global assessment demonstrated a greater proportion of “improved” and “remarkably improved” patients in the HCQ group (51.4% versus 8.7% in the placebo group [P = 0.0002 between groups]). The other secondary end points supported the efficacy of HCQ. Cellulitis, drug eruption, hepatic dysfunction, and Stevens-Johnson syndrome were shown to be serious adverse events related to HCQ use. Conclusion: The results of this randomized clinical trial support the efficacy and tolerability of HCQ in patients with CLE.

Original languageEnglish
Pages (from-to)791-799
Number of pages9
JournalArthritis and Rheumatology
Volume69
Issue number4
DOIs
Publication statusPublished - 2017 Apr 1

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Cutaneous Lupus Erythematosus
Hydroxychloroquine
Placebos
Research Personnel
Confidence Intervals
Drug Eruptions
Musculoskeletal Pain
Stevens-Johnson Syndrome
Phase III Clinical Trials
Cellulitis
Systemic Lupus Erythematosus
Fatigue
Japan
Randomized Controlled Trials
Clinical Trials
Safety

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus : A Multicenter, Double-Blind, Randomized, Parallel-Group Trial. / Yokogawa, N.; Eto, H.; Tanikawa, Akiko; Ikeda, T.; Yamamoto, K.; Takahashi, T.; Mizukami, H.; Sato, T.; Yokota, N.; Furukawa, F.

In: Arthritis and Rheumatology, Vol. 69, No. 4, 01.04.2017, p. 791-799.

Research output: Contribution to journalArticle

Yokogawa, N, Eto, H, Tanikawa, A, Ikeda, T, Yamamoto, K, Takahashi, T, Mizukami, H, Sato, T, Yokota, N & Furukawa, F 2017, 'Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus: A Multicenter, Double-Blind, Randomized, Parallel-Group Trial', Arthritis and Rheumatology, vol. 69, no. 4, pp. 791-799. https://doi.org/10.1002/art.40018
Yokogawa, N. ; Eto, H. ; Tanikawa, Akiko ; Ikeda, T. ; Yamamoto, K. ; Takahashi, T. ; Mizukami, H. ; Sato, T. ; Yokota, N. ; Furukawa, F. / Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus : A Multicenter, Double-Blind, Randomized, Parallel-Group Trial. In: Arthritis and Rheumatology. 2017 ; Vol. 69, No. 4. pp. 791-799.
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abstract = "Objective: To assess the efficacy and tolerability of hydroxychloroquine (HCQ) in patients with cutaneous lupus erythematosus (CLE), in a phase III clinical trial conducted in Japan. Methods: We conducted a double-blind, randomized, parallel-group clinical trial. This was a baseline-controlled study, and the group differences were evaluated in an exploratory analysis. A total of 103 patients with active CLE (according to a Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] activity score of ≥4) were included. Patients were randomized 3:1 to receive HCQ or placebo during the 16-week double-blind period, and all patients were given HCQ during the following 36-week single-blind period. The primary efficacy end point was a reduction in the CLASI activity score at week 16. The secondary end points included the central photo evaluation (5-point scale), patient's global assessment (7-point scale), the Skindex-29 score, and investigator's global assessment (7-point scale, based on the other 3 secondary end points). In patients with systemic lupus erythematosus, fatigue and musculoskeletal pain were assessed. Safety was assessed up to week 55. Results: The mean CLASI score at week 16 was significantly improved from baseline in both the HCQ group and the placebo group: mean change −4.6 (95{\%} confidence interval [95{\%} CI] −6.1, −3.1) (P < 0.0001), and mean change −3.2 (95{\%} CI −5.1, −1.3) (P = 0.002), respectively, without between-group difference (P = 0.197). The investigator's global assessment demonstrated a greater proportion of “improved” and “remarkably improved” patients in the HCQ group (51.4{\%} versus 8.7{\%} in the placebo group [P = 0.0002 between groups]). The other secondary end points supported the efficacy of HCQ. Cellulitis, drug eruption, hepatic dysfunction, and Stevens-Johnson syndrome were shown to be serious adverse events related to HCQ use. Conclusion: The results of this randomized clinical trial support the efficacy and tolerability of HCQ in patients with CLE.",
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AU - Eto, H.

AU - Tanikawa, Akiko

AU - Ikeda, T.

AU - Yamamoto, K.

AU - Takahashi, T.

AU - Mizukami, H.

AU - Sato, T.

AU - Yokota, N.

AU - Furukawa, F.

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N2 - Objective: To assess the efficacy and tolerability of hydroxychloroquine (HCQ) in patients with cutaneous lupus erythematosus (CLE), in a phase III clinical trial conducted in Japan. Methods: We conducted a double-blind, randomized, parallel-group clinical trial. This was a baseline-controlled study, and the group differences were evaluated in an exploratory analysis. A total of 103 patients with active CLE (according to a Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] activity score of ≥4) were included. Patients were randomized 3:1 to receive HCQ or placebo during the 16-week double-blind period, and all patients were given HCQ during the following 36-week single-blind period. The primary efficacy end point was a reduction in the CLASI activity score at week 16. The secondary end points included the central photo evaluation (5-point scale), patient's global assessment (7-point scale), the Skindex-29 score, and investigator's global assessment (7-point scale, based on the other 3 secondary end points). In patients with systemic lupus erythematosus, fatigue and musculoskeletal pain were assessed. Safety was assessed up to week 55. Results: The mean CLASI score at week 16 was significantly improved from baseline in both the HCQ group and the placebo group: mean change −4.6 (95% confidence interval [95% CI] −6.1, −3.1) (P < 0.0001), and mean change −3.2 (95% CI −5.1, −1.3) (P = 0.002), respectively, without between-group difference (P = 0.197). The investigator's global assessment demonstrated a greater proportion of “improved” and “remarkably improved” patients in the HCQ group (51.4% versus 8.7% in the placebo group [P = 0.0002 between groups]). The other secondary end points supported the efficacy of HCQ. Cellulitis, drug eruption, hepatic dysfunction, and Stevens-Johnson syndrome were shown to be serious adverse events related to HCQ use. Conclusion: The results of this randomized clinical trial support the efficacy and tolerability of HCQ in patients with CLE.

AB - Objective: To assess the efficacy and tolerability of hydroxychloroquine (HCQ) in patients with cutaneous lupus erythematosus (CLE), in a phase III clinical trial conducted in Japan. Methods: We conducted a double-blind, randomized, parallel-group clinical trial. This was a baseline-controlled study, and the group differences were evaluated in an exploratory analysis. A total of 103 patients with active CLE (according to a Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] activity score of ≥4) were included. Patients were randomized 3:1 to receive HCQ or placebo during the 16-week double-blind period, and all patients were given HCQ during the following 36-week single-blind period. The primary efficacy end point was a reduction in the CLASI activity score at week 16. The secondary end points included the central photo evaluation (5-point scale), patient's global assessment (7-point scale), the Skindex-29 score, and investigator's global assessment (7-point scale, based on the other 3 secondary end points). In patients with systemic lupus erythematosus, fatigue and musculoskeletal pain were assessed. Safety was assessed up to week 55. Results: The mean CLASI score at week 16 was significantly improved from baseline in both the HCQ group and the placebo group: mean change −4.6 (95% confidence interval [95% CI] −6.1, −3.1) (P < 0.0001), and mean change −3.2 (95% CI −5.1, −1.3) (P = 0.002), respectively, without between-group difference (P = 0.197). The investigator's global assessment demonstrated a greater proportion of “improved” and “remarkably improved” patients in the HCQ group (51.4% versus 8.7% in the placebo group [P = 0.0002 between groups]). The other secondary end points supported the efficacy of HCQ. Cellulitis, drug eruption, hepatic dysfunction, and Stevens-Johnson syndrome were shown to be serious adverse events related to HCQ use. Conclusion: The results of this randomized clinical trial support the efficacy and tolerability of HCQ in patients with CLE.

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