The Present and Future of Clinical Research for Korean Lupus Patients

Dam Kim; Soo-Kyung Cho; Yoon-Kyoung Sung

doi:10.4078/jrd.2014.21.2.54

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This article has been corrected. See "The Present and Future of Clinical Research for Korean Lupus Patients" in Volume 21 on page 223.

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Kim, Cho, and Sung: The Present and Future of Clinical Research for Korean Lupus Patients

Review Article

J Rheum Dis 2014;21(2):54-63.

Published online: 31 October 2014

DOI: https://doi.org/10.4078/jrd.2014.21.2.54

The Present and Future of Clinical Research for Korean Lupus Patients

Dam Kim, Soo-Kyung Cho, Yoon-Kyoung Sung

Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea

Corresponding to: Yoon-Kyoung Sung, Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Wangsimni-ro, Seongdong-gu, Seoul 133-792, Korea. E-mail: sungyk@hanyang.ac.kr

Received 9 April 2014 Revised 24 April 2014 Accepted 25 April 2014

This is a Free Access article, which permits unrestricted non-commerical use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Systemic lupus erythematosus (SLE) is considered to be the prototype of systemic autoimmune disease because it involves the most immune cells and it can affect all organs of the human body. Despite the advances in understanding the etiology and pathogenesis of SLE, a sobering fact is that only a few drugs have been licensed for its treatment. This may be associated with the difficulties in performing clinical trials due to its diverse clinical manifestations and comorbidities of SLE, as well as difficulties in determining the disease outcome. To determine the natural course and drug response of SLE patients, various observational studies have been conducted in Western countries. However, in Korea, sufficiently powered prospective clinical studies are scarce. In this review, we conducted a systematic review to be aware of the current status of clinical studies in Korean SLE patients. Identifying the top-ics for clinical studies that have been performed helps determine how the clinical research should be conducted for Korean SLE patients.

Keywords: Lupus erythematosus, Systemic, Clinical study, Korean

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Figure 1.

Selection of studies included in this review of systemic lupus erythematosus clinical researches.

Table 1.

Summary of the studies about lupus nephritis clinical researches in Korea

No.	1st. author	Year	Characteristics of population	Sample size	Outcome	Design
1	SJ Moon (14)	2013	Remission of LN	108	Renal relapse	Retrospective
2	SG Lee (17)	2012	LN class II	15	Progression to class III or IV	Retrospective
3	HS Koo (12)	2011	LN with MMF or CYC	71	Progression to ESRD or mortality	Retrospective
4	MW So (13)	2011	Proliferative LN	201	Renal relapse and CRF	Retrospective
5	SH Kang (15)	2011	ESRD with RRT, LN	59	Survival and complication	Retrospective
6	T Lee (10)	2010	Refractory diffuse proliferative LN	9	Safety and efficacy	Prospective
7	SJ You (18)	2009	LN	67	Pathologic diagnosis	Retrospective
8	JE Kim (19)	2009	Biopsy proven LN	100	Therapeutic outcome	Retrospective
9	SJ Moon (20)	2008	Proliferative LN	43	Effect of MMF vs. CYC	Retrospective
10	YG Kim (21)	2008	Diffuse proliferative LN treated with IV CYC	42	Response rates and lab. Indices	Retrospective
11	SS Seong (11)	2007	LN treated with IV CYC	104	Efficacy and adverse events	Retrospective
12	JY Youm (9)	2005	Refractory LN	4	Safety and efficacy of rituximab	Prospective
13	MC Park (16)	2004	Proliferative LN women treated with IV CYC	67	Amenorrhea, pregnancy and fetal outcome	Retrospective
14	YS Goo (22)	2004	ESRD with LN	45	Lupus activity	Retrospective
15	CW Yoo (23)	2000	Diffuse proliferative LN treated with IV CYC	21	Progression of renal pathology or function	Retrospective
16	HJ Jin (24)	2000	LN	221	Remission, mortality	Retrospective

LN: lupus nephritis, MMF: mycophenolate mofetil, CYC: cyclophosphamide, ESRD: end stage renal disease, CRF: chronic renal failure, RRT: renal replacement therapy, IV: intravenous.

Table 2.

Summary of the studies about lupus outcome clinical researches in Korea

No.	1st. author	Year	Characteristics of population	Sample size	Design	Design
1	HS Ko (43)	2011	Pregnancies with SLE	183	Pregnancy outcome	Retrospective
2	KY Kang (29)	2011	SLE	101	Causes of death	Retrospective
3	KY Kang (30)	2010	SLE	914	Incidence of cancer	Retrospective
4	SY Kim (38)	2008	Full-term babies born to SLE mother	28	Neonatal prognosis	Retrospective
5	YK Sung (33)	2007	SLE	588	Prevalence of systemic damage (SDI)	Cross-sectional
6	HS Kang (39)	2006	Neonates born to SLE mother	29	Clinical characteristics and outcome	Retrospective
7	HS Baek (40)	2006	Neonates born to SLE mother	49	Incidence of congenital heart block and clinical outcome	Retrospective
8	BC Chun (32)	2005	SLE	466	Mortality and cancer incidence	Prospective
9	JH Shin (42)	2003	Pregnancies with SLE	49	Rate of flare and pregnancy loss or fetal outcome	Retrospective
10	YK Sung (34)	2002	SLE	111	Health-related QOL	Cross-sectional
11	WU Kim (41)	1997	Pregnancies with SLE	91	Pregnancy outcome	Retrospective
12	JH Chun (31)	1994	SLE	167	Prevalence and clinical manifestations	Retrospective

SLE: systemic lupus erythematosus, SDI: systemic damage index, QOL: quality of life.

Table 3.

Summary of the studies about lupus comorbidity clinical researches in Korea

No.	1st. author	Year	Characteristics of population	Sample size	Outcome	Design
1	SM Jung (52)	2013	PRES with SLE	15	Clinical profile and outcomes	Retrospective
2	SW Lee (68)	2013	SLE	160	Early serious infection	Retrospective
3	SY Bang (69)	2012	Refractory SLE treated with RTX	39	Effectiveness and safety	Retrospective
4	JM Kim (46)	2012	SLE with Idiopathic intracranial hypertension	8	Characteristics	Retrospective
5	JM Kim (70)	2012	SLE with HPS	15	Characteristics and outcome	Case-control
6	YJ Park (71)	2011	SLE	101	BMD	Case-control
7	YJ Ha (61)	2011	GDM with SLE	127	Risk of developing GDM	Retrospective
8	DH Oh (47)	2011	SLE with memory complaint	19	Neuropsychological test and brain SPECT	Retrospective
9	JM Kim (50)	2011	SLE with meningitis	20	Clinical features and outcome	Case-control
10	SK Kwok (55)	2011	SLE with DAH	21	Clinical features and outcome	Case-control
11	YH Lee (72)	2010	SLE	134	Prevalence of HPV	Cross-sectional
12	KS Woo (73)	2010	SLE	88	APS	Retrospective
13	CK Yoon (74)	2009	SLE	260	Retinopathy	Retrospective
14	MY Her (56)	2009	SLE with abnormal liver enzyme	46	Toxic hepatitis	Retrospective
15	YI Bae (58)	2009	SLE	117	Dermatologic manifestation	Retrospective
16	HJ Kim (53)	2009	SLE with invasive fungal infection	12	Nature and outcome	Retrospective
17	SJ Jeong (75)	2009	SLE	110	Infectious complication	Case-control
18	SK Kwok (76)	2009	SLE with TTP	26	Nature and outcome of TTP	Case-control
19	BY Kim (59)	2008	SLE	22	Audiovestibular manifestations	Retrospective
20	KC Oh (77)	2008	SLE with Neuropsychiatric symptoms	38	MR manifestations	Retrospective
21	YG Kim (78)	2008	SLE with protein-losing enteropathy, lupus enteritis, idiopathic PLE	7/15/11	Nature	Case-control
22	SK Kwok (79)	2007	SLE with acute abdominal pain	87	Lupus enteritis	Retrospective
23	BS Cho (49)	2007	NPSLE	25	Clinical and brain MRI	Case-control
24	SJ Yun (60)	2007	SLE	122	Hair loss pattern	Cross-sectional
25	SN Oh (57)	2004	SLE with osteonecrosis	37	MR imaging	Retrospective
26	JE Yun (54)	2002	SLE	283	M. Tuberculosis infection	Retrospective
27	CK Lee (44)	2002	SLE	175	Acute abdominal pain, lupus enteritis	Case-control
28	MK Lim (80)	2001	SLE	128	Serum ferritin, SLEDAI score	Prospective
29	CH Suh (81)	2001	SLE	173	Infection, disease activity, corticosteroid dose	Case-control
30	MK Lim (51)	2000	SLE	26	NPSLE and MR imaging, MR spectroscopy	Retrospective
31	HY Kim (82)	1999	SLE with tuberculosis	22	CXR and CT	Retrospective
32	WU Kim (45)	1999	SLE with ARDS	19	Cause of death, clinical characteristics	Case-control
33	JY Byun (83)	1999	SLE with acute abdominal pain	33	CT finding	Retrospective
34	CH Lee (48)	1996	NPSLE	24	Characteristics	Case-control
35	HI Yang (84)	1996	SLE	322	AVN	Retrospective

PRES: posterior reversible encephalopathy syndrome, SLE: systemic lupus erythematosus, RTX: rituximab, HPS: hemophagocytic syndrome, BMD: bone mineral density, GDM: glucocorticoid-induced diabetes mellitus, SPECT: single-photon emission computed tomography, DAH: diffuse alveolar hemorrhage, HPV: human papilloma virus, APS: anti-phospholipid antibody syndrome, TTP: thrombotic thrombocytopenic purpura, MR: magnetic resonance, PLE: protein losing enteropathy, NPSLE: neuropsychiatric systemic lupus erythematosus, M. Tuberculosis: mycobacterium tuberculosis, SLEDAI: systemic lupus erythematosus disease activity index, CXR: chest x-ray, CT: computed tomography, ARDS: adult respiratory distress syndrome, AVN: avascular necrosis.

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