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1. Distinctive profile of monomeric and polymeric anti-SSA/Ro52 immunoglobulin A1 isoforms in saliva of patients with primary Sjögren’s syndrome and Sicca

Author

Chiang, Samantha, Grogan, Tristan, Kamounah, Sarah, Wei, Fang, Tayob, Nabihah, Kim, Ju Yeon, Park, Jin Kyun, Akin, David, Elashoff, David A, Pedersen, Anne Marie Lynge, Song, Yeong Wook, Wong, David TW, and Chia, David

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Autoimmune Disease, Dental/Oral and Craniofacial Disease, Clinical Research, 2.1 Biological and endogenous factors, Aetiology, Inflammatory and immune system, Humans, Saliva, Sjogren's Syndrome, Immunoglobulin A, Autoantibodies, Immunoglobulin G, Autoimmune Diseases, Autoimmunity, Clinical sciences
Abstract

ObjectivePrimary Sjögren's syndrome (pSS) is the second most common chronic autoimmune connective tissue disease. Autoantibodies, immunoglobulin (IgG) anti-SSA/Ro, in serum is a key diagnostic feature of pSS. Since pSS is a disease of the salivary gland, we investigated anti-SSA/Ro52 in saliva.MethodsUsing a novel electrochemical detection platform, Electric Field-Induced Release and Measurement, we measured IgG/M/A, IgG, IgA, IgA isotypes (IgA1 and IgA2) and IgA1 subclasses (polymeric and monomeric IgA1) to anti-SSA/Ro52 in saliva supernatant of 34 pSS, 35 dry eyes and dry mouth (patients with Sicca) and 41 health controls.ResultsSaliva IgG/M/A, IgG, IgA, IgA isotypes and IgA1 subclasses to anti-SSA/Ro52 differed significantly between pSS, non-pSS Sicca and healthy subjects. Elevated monomeric IgA1 was observed in patients with non-pSS Sicca while elevated polymeric IgA1 (pIgA1) was observed in patients with pSS. Salivary polymeric but not monomeric IgA1 (mIgA1) isoform correlated with focus score (r2=0.467, p=0.001) CONCLUSIONS: Salivary anti-Ro52 polymeric IgA1 isoform is associated with glandular inflammation in pSS, while salivary monomeric IgA1 is associated with Sicca. Whether IgA1 isotope switching plays a role in the progression of the Sicca to pSS warrants further investigation.

Published
2024

8. Reliability and validity of PROMIS physical function, pain interference, and fatigue as patient reported outcome measures in adult idiopathic inflammatory myopathies: International study from the OMERACT myositis working group

Author

DiRenzo, Dana, Saygin, Didem, de Groot, Ingrid, Bingham III, Clifton O., Lundberg, Ingrid E., Needham, Merrilee, Park, Jin Kyun, Regardt, Malin, Sarver, Catherine, Song, Yeong Wook, Maxwell, Lara, Beaton, Dorcas, de Visser, Marianne, Christopher-Stine, Lisa, Mecoli, Christopher A., and Alexanderson, Helene

Published
2023
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18. Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo‐controlled trial in North East Asia

Author

Suh, Chang‐Hee, primary, Lee, Yoonhee, additional, Yoo, Sang‐Bae, additional, Quasny, Holly, additional, Navarro Rojas, Aldo Amador, additional, Hammer, Anne, additional, Song, Yeong‐Wook, additional, Kang, Young Mo, additional, Cho, Chul‐Soo, additional, Park, Won, additional, Kwok, Seung‐Ki, additional, Lee, Seung‐Geun, additional, Chung, Won Tae, additional, and Bae, Sang‐Cheol, additional

Published
2023
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19. Genetic associations of leptin-related polymorphisms with systemic lupus erythematosus

Author

Zhao, Jian, Wu, Hui, Langefeld, Carl D, Kaufman, Kenneth M, Kelly, Jennifer A, Bae, Sang-Cheol, networks, Marta E Alarcón-Riquelme for the BIOLUPUS and GENLES, Alarcón, Graciela S, Anaya, Juan-Manuel, Criswell, Lindsey A, Freedman, Barry I, Kamen, Diane L, Gilkeson, Gary S, Jacob, Chaim O, James, Judith A, Merrill, Joan T, Gaffney, Patrick M, Sivils, Kathy Moser, Niewold, Timothy B, Petri, Michelle A, Song, Seung Taek, Jeong, Hye-jin, Ramsey-Goldman, Rosalind, Reveille, John D, Scofield, R Hal, Stevens, Anne M, Boackle, Susan A, Vilá, Luis M, Chang, Deh-Ming, Song, Yeong Wook, Vyse, Timothy J, Harley, John B, Brown, Elizabeth E, Edberg, Jeffrey C, Kimberly, Robert P, Hahn, Bevra H, Grossman, Jennifer M, Tsao, Betty P, and La Cava, Antonio

Subjects
Biomedical and Clinical Sciences, Immunology, Clinical Research, Autoimmune Disease, Genetic Testing, Genetics, Lupus, 2.1 Biological and endogenous factors, Aetiology, Inflammatory and immune system, Case-Control Studies, Genetic Predisposition to Disease, Genotype, Humans, Leptin, Lupus Erythematosus, Systemic, Polymorphism, Single Nucleotide, Systemic lupus erythematosus, Leptin pathway, Gene polymorphisms, Marta E. Alarcón-Riquelme for the BIOLUPUS and GENLES networks
Abstract

Leptin is abnormally elevated in the plasma of patients with systemic lupus erythematosus (SLE), where it is thought to promote and/or sustain pro-inflammatory responses. Whether this association could reflect an increased genetic susceptibility to develop SLE is not known, and studies of genetic associations with leptin-related polymorphisms in SLE patients have been so far inconclusive. Here we genotyped DNA samples from 15,706 SLE patients and healthy matched controls from four different ancestral groups, to correlate polymorphisms of genes of the leptin pathway to risk for SLE. It was found that although several SNPs showed weak associations, those associations did not remain significant after correction for multiple testing. These data do not support associations between defined leptin-related polymorphisms and increased susceptibility to develop SLE.

Published
2015

31. Fine mapping of Xq28: both MECP2 and IRAK1 contribute to risk for systemic lupus erythematosus in multiple ancestral groups

Author

Kaufman, Kenneth M, Zhao, Jian, Kelly, Jennifer A, Hughes, Travis, Adler, Adam, Sanchez, Elena, Ojwang, Joshua O, Langefeld, Carl D, Ziegler, Julie T, Williams, Adrienne H, Comeau, Mary E, Marion, Miranda C, Glenn, Stuart B, Cantor, Rita M, Grossman, Jennifer M, Hahn, Bevra H, Song, Yeong Wook, Yu, Chack-Yung, James, Judith A, Guthridge, Joel M, Brown, Elizabeth E, Alarcón, Graciela S, Kimberly, Robert P, Edberg, Jeffrey C, Ramsey-Goldman, Rosalind, Petri, Michelle A, Reveille, John D, Vilá, Luis M, Anaya, Juan-Manuel, Boackle, Susan A, Stevens, Anne M, Freedman, Barry I, Criswell, Lindsey A, Group, Bernardo A Pons-Estel on behalf of the Argentine Collaborative, Lee, Joo-Hyun, Lee, Ji-Seon, Chang, Deh-Ming, Scofield, R Hal A, Gilkeson, Gary S, Merrill, Joan T, Niewold, Timothy B, Vyse, Timothy James, Bae, Sang-Cheol, network, Marta E Alarcón-Riquelme on behalf of the BIOLUPUS, Jacob, Chaim O, Sivils, Kathy Moser, Gaffney, Patrick M, Harley, John B, Sawalha, Amr H, and Tsao, Betty P

Subjects
Human Genome, Autoimmune Disease, Lupus, Genetics, Clinical Research, 2.1 Biological and endogenous factors, Aetiology, Inflammatory and immune system, Base Sequence, Chromosome Mapping, Chromosomes, Human, X, Genetic Predisposition to Disease, Genotype, Haplotypes, Humans, Interleukin-1 Receptor-Associated Kinases, Lupus Erythematosus, Systemic, Methyl-CpG-Binding Protein 2, Molecular Sequence Data, Polymorphism, Single Nucleotide, Racial Groups, Real-Time Polymerase Chain Reaction, Risk Factors, Argentine Collaborative Group, BIOLUPUS network, Clinical Sciences, Immunology, Public Health and Health Services, Arthritis & Rheumatology
Abstract

ObjectivesThe Xq28 region containing IRAK1 and MECP2 has been identified as a risk locus for systemic lupus erythematosus (SLE) in previous genetic association studies. However, due to the strong linkage disequilibrium between IRAK1 and MECP2, it remains unclear which gene is affected by the underlying causal variant(s) conferring risk of SLE.MethodsWe fine-mapped ≥136 SNPs in a ∼227 kb region on Xq28, containing IRAK1, MECP2 and seven adjacent genes (L1CAM, AVPR2, ARHGAP4, NAA10, RENBP, HCFC1 and TMEM187), for association with SLE in 15 783 case-control subjects derived from four different ancestral groups.ResultsMultiple SNPs showed strong association with SLE in European Americans, Asians and Hispanics at p

Published
2013

37. Correction to: Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan

Author

Takeuchi, Tsutomu, Tanaka, Yoshiya, Tanaka, Sakae, Kawakami, Atsushi, Song, Yeong-Wook, Chen, Yi-Hsing, Rokuda, Mitsuhiro, Izutsu, Hiroyuki, Ushijima, Satoshi, Kaneko, Yuichiro, Nakashima, Yoshihiro, Shiomi, Teruaki, and Yamada, Emi

Published
2020
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39. Circulating TNF-like protein 1A (TL1A) is elevated early in rheumatoid arthritis and depends on TNF

Author

Song, Yun-Jeong, Choi, In Ah., Meylan, Françoise, Demoruelle, M. Kristen, Farley, Taylor, Richard, Arianne C., Hawley, Eric, Botson, John, Hong, Yoo Jin, Lee, Eun Young, Mian, Sabina R., Hamilton, Bartlett C., Thiele, Geoffrey M., Mikuls, Ted R., Gara, Naveen, Ward, Chris D., Lamberth, Sarah, Deane, Kevin D., Heller, Theo, Ward, Michael M., Lee, David M., Migone, Thi-Sau, Stohl, William, O’Dell, James R., Norris, Jill M., Holers, V. Michael, Gregersen, Peter, Song, Yeong-Wook, and Siegel, Richard M.

Published
2020
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40. Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan

Author

Takeuchi, Tsutomu, Tanaka, Yoshiya, Tanaka, Sakae, Kawakami, Atsushi, Song, Yeong-Wook, Chen, Yi-Hsing, Rokuda, Mitsuhiro, Izutsu, Hiroyuki, Ushijima, Satoshi, Kaneko, Yuichiro, Nakashima, Yoshihiro, Shiomi, Teruaki, and Yamada, Emi

Published
2020
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41. Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo‐controlled trial in North East Asia.

Author

Suh, Chang‐Hee, Lee, Yoonhee, Yoo, Sang‐Bae, Quasny, Holly, Navarro Rojas, Aldo Amador, Hammer, Anne, Song, Yeong‐Wook, Kang, Young Mo, Cho, Chul‐Soo, Park, Won, Kwok, Seung‐Ki, Lee, Seung‐Geun, Chung, Won Tae, and Bae, Sang‐Cheol

Subjects
SYSTEMIC lupus erythematosus, KOREANS, BELIMUMAB, CLINICAL trials, LUPUS erythematosus, AUTOANTIBODY analysis
Abstract

Aim: This post hoc analysis evaluated the efficacy and safety of intravenous belimumab 10 mg/kg in the South Korean subgroup of patients with systemic lupus erythematosus (SLE) enrolled in the North East Asia (NEA) study (GSK Study BEL113750; NCT01345253). Methods: NEA was a double‐blind, placebo‐controlled, randomized Phase 3 trial. Patients with active, autoantibody‐positive SLE were randomized 2:1 to belimumab or placebo plus standard therapy administered on Days 0, 14, and 28, and then every 28 days up to Week 48. The primary efficacy endpoint in this analysis was SLE Responder Index 4 (SRI‐4) response rate at Week 52, defined as the proportion of patients achieving a ≥4‐point reduction in Safety of Estrogens in Lupus Erythematosus National Assessment‐SLE Disease Activity Index (SELENA‐SLEDAI) score, no worsening (<0.3 increase from baseline) in Physician Global Assessment, no new British Isles Lupus Assessment Group (BILAG) A domain and <2 new BILAG B domain scores. Results: Among 100 South Korean patients enrolled in NEA, 54/66 (81.8%) belimumab‐ and 24/34 (70.6%) placebo‐treated patients completed the double‐blind phase. Significantly more belimumab‐ than placebo‐treated patients achieved SRI‐4 response at Week 52 (n = 35/66, 53.0% vs. n = 8/34, 23.5%; odds ratio [OR; 95% confidence interval (CI)]: 3.67 [1.45, 9.28]; p =.0061). The proportion of patients experiencing ≥1 adverse event was similar between groups (belimumab: n = 60/66, 90.9% vs. placebo: n = 31/34, 91.2%). No new safety signals emerged in this subgroup analysis. Conclusion: Belimumab was efficacious for the treatment of SLE and well tolerated among the South Korean subgroup of patients from the NEA study. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Immunoassay Detects Salivary Anti-SSA/Ro-52 Autoantibodies in Seronegative Patients with Primary Sjögren's Syndrome

Author

Kamounah, Sarah, Tayob, Nabihah, Chiang, Samantha, Wei, Fang, Park, Jin Kyun, Kwon, Hyun Mi, Feng, Ziding, Chia, David, Pedersen, Anne Marie Lynge, Song, Yeong Wook, Wong, David T. W., Kamounah, Sarah, Tayob, Nabihah, Chiang, Samantha, Wei, Fang, Park, Jin Kyun, Kwon, Hyun Mi, Feng, Ziding, Chia, David, Pedersen, Anne Marie Lynge, Song, Yeong Wook, and Wong, David T. W.

Abstract

The diagnostic work-up for Sjögren's syndrome is challenging and complex, including testing for serum autoantibodies to SSA/Ro and a labial salivary gland biopsy. Furthermore, the diagnosis is often delayed. In this study, we tested the hypothesis that anti-SSA/Ro autoantibodies are detectable in the saliva of patients with primary Sjögren's syndrome (pSS) because the disease affects the salivary glands, and these autoantibodies display greater discriminatory performance in saliva than in serum. SSA/Ro-52 Ags were used to develop what is, to our knowledge, a novel quantitative electrochemical-based immunoassay: the electric field-induced release and measurement (EFIRM) platform. The clinical utility was determined by measuring salivary anti-SSA/Ro-52 autoantibodies in patients with pSS and sicca (n = 34), patients without pSS with sicca (n = 35), and healthy subjects (n = 41). The statistical analysis of discrimination included the area under the receiver operating characteristic curve. Salivary anti-SSA/Ro-52 autoantibodies were measured in 94% (32 of 34) of patients with pSS with 85% (29 of 34) seropositivity. Four of the five seronegative patients with pSS had EFIRM-measurable anti-SSA/Ro-52 autoantibodies in saliva. Additionally, 60% (21 of 35) of the seronegative patients without pSS who had sicca had EFIRM-detectable SSA/Ro-52 autoantibodies in saliva, indicating the onset of autoimmune disease. Two of the 41 healthy control subjects had EFIRM-detectable SSA/Ro-52 autoantibodies in their saliva. Salivary SSA/Ro-52 autoantibodies significantly discriminated patients with pSS or patients with the initial stage of autoimmune disease from healthy subjects with an area under the receiver operating characteristic curve of 0.91. Our findings suggest that the proposed saliva SSA/Ro-52 immunoassay improves early and accurate diagnosis of seronegative patients with pSS and patients with early-onset autoimmune disease.

Published
2023

46. Performance of the 2016 ACR-EULAR Myositis Response Criteria in Adult Dermatomyositis/Polymyositis Therapeutic Trials and Consensus Profiles

Author

Saygin, Didem, Kim, Hannah, Douglas, Christian, Erman, Brian, Wilkerson, Jesse, McGrath, John J., Oddis, Chester V., Lundberg, Ingrid E., Amato, Anthony A., La Torre, Ignacio García-De, Chinoy, Hector, Fiorentino, David, Chung, Lorinda, Song, Yeong-Wook, Miller, Frederick W, Ruperto, Nicolino, Vencovsky, Jiri, Aggarwal, Rohit, and Rider, Lisa G.

Subjects
Rheumatology, Pharmacology (medical)
Abstract

Objective The ACR-EULAR Myositis Response Criteria (MRC) were developed as a composite measure using absolute percentage change in six core set measures (CSMs). We aimed to further validate the MRC by assessing the contribution of each CSM, frequency of strength vs extramuscular activity improvement, representation of patient-reported outcome measures (PROM), and frequency of CSM worsening. Methods Data from adult dermatomyositis/polymyositis patients in the rituximab (n = 147), etanercept (n = 14), and abatacept (n = 19) trials, and consensus patient profiles (n = 232) were evaluated. The Total Improvement Score (TIS), number of improving vs worsening CSMs, frequency of improvement with and without muscle-related CSMs, and contribution of PROM were evaluated by MRC category. Regression analysis was performed to assess contribution of each CSM to the MRC. Results Of 412 adults with dermatomyositis/polymyositis, there were 37%, 24%, 25%, and 14% with no, minimal, moderate, and major MRC improvement, respectively. The number of improving CSMs and absolute percentage change in all CSMs increased by improvement category. In minimal-moderate improvement, only physician-reported disease activity contributed significantly more than expected by MRC. Of patients with at least minimal improvement, 95% had improvement in muscle-related measures and a majority (84%) had improvement in PROM. Patients with minimal improvement had worsening in a median of 1 CSM, and most patients with moderate-major improvement had no worsening CSMs. Physician assessment of change generally agreed with MRC improvement categories. Conclusion The ACR-EULAR MRC performs consistently across multiple studies, further supporting its use as an efficacy end point in future myositis therapeutic trials.

Published
2023

49. Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study

Author

Park, Min-Chan, Matsuno, Hiroaki, Kim, Jinseok, Park, Sung-Hwan, Lee, Sang-Heon, Park, Yong-Beom, Lee, Yun Jong, Lee, Sang-Il, Park, Won, Sheen, Dong Hyuk, Choe, Jung-Yoon, Choi, Chan-Bum, Hong, Seung-Jae, Suh, Chang-Hee, Lee, Shin-Seok, Cha, Hoon-Suk, Yoo, Bin, Hur, Jin-Wuk, Kim, Geun-Tae, Yoo, Wan-Hee, Baek, Han Joo, Shin, Kichul, Shim, Seung Cheol, Yang, Hyung-In, Kim, Hyun Ah, Park, Kyung-Su, Choi, In Ah, Lee, Jisoo, Tomomitsu, Masato, Shin, Seonghye, Lee, Jiyoon, and Song, Yeong Wook

Published
2019
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