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

Background/Purpose:

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.

Methods:

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 200–400mg/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.

Results:

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 (2–24) to 4.1 (0–11). 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].

Table 1.

Pared t-test	n	CLASI Activity (Pre)	CLASI Activity (Post)	Difference	t	p value
total	30	9.6	4.1	-5.3	-6.17	<.0001
SLE	17	9.2	4.2	-5.0	-4.37	0.0005
not SLE	13	10.2	4.0	-6.2	-4.27	0.0011
ACLE	8	8.8	4.5	-4.3	-2.37	0.0493
not ACLE	22	10.0	4.0	-6.0	-5.76	<.0001
SCLE	5	10.8	2.8	-8.0	-3.95	0.0168
not SCLE	25	9.4	4.4	-5.0	-5.12	<.0001
DLE	11	12.7	6.0	-6.7	-3.91	0.0029
not DLE	19	7.8	3.0	-4.8	-4.80	0.0001
Annular erythema	8	6.3	1.6	-4.6	-5.95	0.0006
not annular erythema	22	10.9	5.0	-5.9	-4.92	<.0001
Duration < 5years	15	9.5	4.0	-5.5	-4.77	0.0003
Duration >= 5years	15	9.8	4.2	-5.6	-3.94	0.0015
PSL <5mg/d	15	9.4	3.5	-5.9	-4.1323	0.0010
PSL >=5mg/d*	15	9.9	4.4	-5.5	-4.598	0.0004
Smoking	17	12.9	5.6	-7.3	-3.31	0.0162
not smoking	13	8.7	3.7	-5.0	-5.199	<0.0001
CLASI Pre <9	17	4.9	2.8	-2.1	-2.9756	0.0089
CLASI Pre =>9	13	15.8	5.8	-10.0	-12.2747	<0.0001
* median of PSL was 3.75mg/d

Table 2.

Multivariable analysis	F	p value
Full model	3.64	0.0138
SLE	0.05	0.834
ACLE	0.63	0.4443
SCLE	0.33	0.5744
DLE	0.92	0.3557
Annular erythema	1.23	0.2887
Duration	1.08	0.3201
PSL	1.00	0.4899
Smoking	0.09	0.7749
Pre CLASI Activity	30.11	<.0001

Conclusion:

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
DOI:

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