Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Response to Hydroxychloroquine in Japanese Patients with Cutaneous Lupus Erythematosus Using the Cutaneous Lupus Erythematosus Disease Area and Severity Index.
Yokogawa1, Naoto, Ikeda2, Takaharu, Aizawa3, Kyo, Tanikawa4, Akiko, Amagai4, Masayuki, Kato5, Yukihiko, Momose6, Yoko
Tokyo Metropolitan Tama Medical Center, Section of Rheumatology, Tokyo, Japan
Wakayama Medical University, Department of Dermatology, Wakayama, Japan
Sanofi-Aventis K.K. Biostatistics & Programming, Tokyo, Japan
Keio University School of Medicine, Department of Dermatology, Tokyo, Japan
Tokyo Metropolitan Tama Medical Center, Section of Dermatology, Tokyo, Japan
St. Luke's International Hospital, Department of Dermatology, Tokyo, Japan
To evaluate the the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Japanese cutaneous lupus erythematosus (CLE) patients to design a clinical trial of Hydroxychloroquine (HCQ) in Japan.
This is a prospective cohort study of CLE patients with or without systemic lupus erythematosus (SLE) who started HCQ at four major institutions of Japanese Hydroxychloroquine Study Group: Tokyo Metropolitan Tama Medical Center, Wakayama Medical University, Saint Luke's Hospital, Keio University. All institutions obtained the Institutional Review Board approval for the use of HCQ. Ophthalmologic exams were mandated before starting HCQ and every six months after starting HCQ. The dose of HCQ was 200400mg/d, and less than 6.5mg/kg/d. The therapeutic responses are assessed at four months by the change of CLASI activity score. Patients were categorized into responders (improved) or non-responders (unchanged or worsened) using the criteria of 4-point or 20% decrease in the CLASI activity score.
Thirty patients, 17 with SLE, were included. Median dose of prednisolone (PSL) before HCQ was 3.75 mg/d. Five patients experienced minor adverse reactions (3 pts with transient eye symptoms, 2 pts had mild gastrointestinal symptoms, 1 pt with possible eruption) but all patients tolerated HCQ. Twenty-six patients (87%) were categorized as responders. The median (range) CLASI activity score of all patients changed from 9.6 (224) to 4.1 (011). Treatment effect of HCQ was consistent across subgroups with regards to baseline characteristics [Table1]. We performed multivariable analysis including severity of CLE (CLASI activity score: 9 or more), presence of SLE, types of CLE (acute CLE, subacute CLE, annular erythema, discoid LE) duration of CLE (5 year or longer), dose of PSL (5mg or more), and smoking. Among them, only CLASI activity score before HCQ revealed statistically significant (F= 30.1 p<0.0001) [Table 2].
|Multivariable analysis||F||p value|
|Pre CLASI Activity||30.11||<.0001|
The cutaneous aspects of SLE can be measured by the CLASI. The CLASI activity score may be a reasonable primary endpoint when performing a clinical trial of HCQ.
To cite this abstract, please use the following information:
Yokogawa, Naoto, Ikeda, Takaharu, Aizawa, Kyo, Tanikawa, Akiko, Amagai, Masayuki, Kato, Yukihiko, et al; Response to Hydroxychloroquine in Japanese Patients with Cutaneous Lupus Erythematosus Using the Cutaneous Lupus Erythematosus Disease Area and Severity Index. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1410