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1. Evaluation and Management of Skin Disease

Author

Hunzelmann, Nicolas, Castelino, Flavia V., Allanore, Yannick, editor, Varga, John, editor, Denton, Christopher P., editor, Kuwana, Masataka, editor, Chung, Lorinda, editor, and Shah, Ami A., editor

Published
2024
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2. Expert consensus on the management of systemic sclerosis-associated interstitial lung disease

Author

Rahaghi, Franck F., Hsu, Vivien M., Kaner, Robert J., Mayes, Maureen D., Rosas, Ivan O., Saggar, Rajan, Steen, Virginia D., Strek, Mary E., Bernstein, Elana J., Bhatt, Nitin, Castelino, Flavia V., Chung, Lorinda, Domsic, Robyn T., Flaherty, Kevin R., Gupta, Nishant, Kahaleh, Bashar, Martinez, Fernando J., Morrow, Lee E., Moua, Teng, Patel, Nina, Shlobin, Oksana A., Southern, Brian D., Volkmann, Elizabeth R., and Khanna, Dinesh

Published
2023
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3. Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator‐Initiated, Multicenter, Double‐Blind, Randomized, Placebo‐Controlled Trial

Author

Khanna, Dinesh, Spino, Cathie, Johnson, Sindhu, Chung, Lorinda, Whitfield, Michael L, Denton, Christopher P, Berrocal, Veronica, Franks, Jennifer, Mehta, Bhavan, Molitor, Jerry, Steen, Virginia D, Lafyatis, Robert, Simms, Robert W, Gill, Anna, Kafaja, Suzanne, Frech, Tracy M, Hsu, Vivien, Domsic, Robyn T, Pope, Janet E, Gordon, Jessica K, Mayes, Maureen D, Schiopu, Elena, Young, Amber, Sandorfi, Nora, Park, Jane, Hant, Faye N, Bernstein, Elana J, Chatterjee, Soumya, Castelino, Flavia V, Ajam, Ali, Wang, Yue, Wood, Tammara, Allanore, Yannick, Matucci‐Cerinic, Marco, Distler, Oliver, Singer, Ora, Bush, Erica, Fox, David A, and Furst, Daniel E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Brain Disorders, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Abatacept, Adult, Double-Blind Method, Female, Gene Expression, Gene Expression Profiling, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Scleroderma, Diffuse, Sequence Analysis, RNA, Severity of Illness Index, Skin, Treatment Outcome, Tumor Necrosis Factor Inhibitors, Visual Analog Scale, Vital Capacity, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

ObjectiveT cells play a key role in the pathogenesis of early systemic sclerosis. This study was undertaken to assess the safety and efficacy of abatacept in patients with diffuse cutaneous systemic sclerosis (dcSSc).MethodsIn this 12-month, randomized, double-blind, placebo-controlled trial, participants were randomized 1:1 to receive either subcutaneous abatacept 125 mg or matching placebo, stratified by duration of dcSSc. Escape therapy was allowed at 6 months for worsening disease. The coprimary end points were change in the modified Rodnan skin thickness score (MRSS) compared to baseline and safety over 12 months. Differences in longitudinal outcomes were assessed according to treatment using linear mixed models, with outcomes censored after initiation of escape therapy. Skin tissue obtained from participants at baseline was classified into intrinsic gene expression subsets.ResultsAmong 88 participants, the adjusted mean change in the MRSS at 12 months was -6.24 units for those receiving abatacept and -4.49 units for those receiving placebo, with an adjusted mean treatment difference of -1.75 units (P = 0.28). Outcomes for 2 secondary measures (Health Assessment Questionnaire disability index and a composite measure) were clinically and statistically significantly better with abatacept. The proportion of subjects in whom escape therapy was needed was higher in the placebo group relative to the abatacept group (36% versus 16%). In the inflammatory and normal-like skin gene expression subsets, decline in the MRSS over 12 months was clinically and significantly greater in the abatacept group versus the placebo group (P < 0.001 and P = 0.03, respectively). In the abatacept group, adverse events occurred in 35 participants versus 40 participants in the placebo group, including 2 deaths and 1 death, respectively.ConclusionIn this phase II trial, abatacept was well-tolerated, but change in the MRSS was not statistically significant. Secondary outcome measures, including gene expression subsets, showed evidence in support of abatacept. These data should be confirmed in a phase III trial.

Published
2020

5. Safety and efficacy of abatacept in early diffuse cutaneous systemic sclerosis (ASSET): open-label extension of a phase 2, double-blind randomised trial

Author

Chung, Lorinda, Spino, Cathie, McLain, Richard, Johnson, Sindhu R, Denton, Christopher P, Molitor, Jerry A, Steen, Virginia D, Lafyatis, Robert, Simms, Robert W, Kafaja, Suzanne, Frech, Tracy M, Hsu, Vivien, Domsic, Robyn T, Pope, Janet E, Gordon, Jessica K, Mayes, Maureen D, Sandorfi, Nora, Hant, Faye N, Bernstein, Elana J, Chatterjee, Soumya, Castelino, Flavia V, Ajam, Ali, Allanore, Yannick, Matucci-Cerinic, Marco, Whitfield, Michael L, Distler, Oliver, Singer, Ora, Young, Amber, Nagaraja, Vivek, Fox, David A, Furst, Daniel E, and Khanna, Dinesh

Published
2020
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7. Clinical characteristics, visceral involvement, and mortality in at-risk or early diffuse systemic sclerosis: a longitudinal analysis of an observational prospective multicenter US cohort

Author

Jaafar, Sara, Lescoat, Alain, Huang, Suiyuan, Gordon, Jessica, Hinchcliff, Monique, Shah, Ami A., Assassi, Shervin, Domsic, Robyn, Bernstein, Elana J., Steen, Virginia, Elliott, Sabrina, Hant, Faye, Castelino, Flavia V., Shanmugam, Victoria K., Correia, Chase, Varga, John, Nagaraja, Vivek, Roofeh, David, Frech, Tracy, and Khanna, Dinesh

Published
2021
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9. Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials.

Author

Saketkoo, Lesley Ann, Mittoo, Shikha, Huscher, Dörte, Khanna, Dinesh, Dellaripa, Paul F, Distler, Oliver, Flaherty, Kevin R, Frankel, Sid, Oddis, Chester V, Denton, Christopher P, Fischer, Aryeh, Kowal-Bielecka, Otylia M, LeSage, Daphne, Merkel, Peter A, Phillips, Kristine, Pittrow, David, Swigris, Jeffrey, Antoniou, Katerina, Baughman, Robert P, Castelino, Flavia V, Christmann, Romy B, Christopher-Stine, Lisa, Collard, Harold R, Cottin, Vincent, Danoff, Sonye, Highland, Kristin B, Hummers, Laura, Shah, Ami A, Kim, Dong Soon, Lynch, David A, Miller, Frederick W, Proudman, Susanna M, Richeldi, Luca, Ryu, Jay H, Sandorfi, Nora, Sarver, Catherine, Wells, Athol U, Strand, Vibeke, Matteson, Eric L, Brown, Kevin K, Seibold, James R, and CTD-ILD Special Interest Group

Subjects
CTD-ILD Special Interest Group, Humans, Lung Diseases, Interstitial, Connective Tissue Diseases, Registries, Consensus, International Cooperation, Societies, Medical, Congresses as Topic, Randomized Controlled Trials as Topic, Idiopathic Pulmonary Fibrosis, Connective tissue disease associated lung disease, Idiopathic pulmonary fibrosis, Interstitial Fibrosis, Rheumatoid lung disease, Systemic disease and lungs, Lung Diseases, Interstitial, Societies, Medical, Respiratory System, Clinical Sciences
Abstract

RationaleClinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities.MethodsThe Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology-a non-profit international organisation dedicated to consensus methodology in identification of outcome measures-conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF).ResultsA core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed.ConclusionIdentification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field.

Published
2014

11. Clinically Recognized Depression and Mental Health Treatment in a Single Center Cohort of Patients with Systemic Sclerosis.

Author

Savoie, Marissa B., Poeschla, Alexandra, Lu, Na, Zhang, Yuqing, Bolster, Marcy B., Schoenfeld, Sara, and Castelino, Flavia V.

Subjects
MENTAL health services, HEALTH facilities, SYSTEMIC scleroderma, CENTER for Epidemiologic Studies Depression Scale, MENTAL depression
Abstract

Introduction. In this study, we investigated the prevalence of depression, depression treatment, and symptom burden in patients with systemic sclerosis (SSc) and examined their associations with the center for epidemiologic studies depression scale revised (CESD-R) scores. Methods. The Prospective Registry in Scleroderma at Massachusetts General Hospital (PRISM) is a longitudinal registry of patients with SSc. Among participants with CESD-R score ≥ 16 , indicating possible depression, a chart review was performed for mental health diagnoses and treatments. We examined the relation of demographic and clinical factors to the presence of mental health diagnoses or treatment using logistic regression. We evaluated the association of SSc symptoms and the COVID-19 pandemic with a CESD-R score using quantile regression. Results. Of 214 patients enrolled in PRISM, 129 participants (38% diffuse and 59% limited) completed at least one CESD-R questionnaire. In the first survey, 29% had possible depression (CESD − R ≥ 16) and 16% had probable depression (CESD − R ≥ 23). Of 20 participants with probable depression, 90% received treatment for a mood disorder. In a multivariable logistic regression model among participants with CESD − R ≥ 16 , none of the evaluated variables (CESD-R score, age, gender, employment status, race, and ethnicity) was associated with mental health diagnosis or treatment. Higher baseline dyspnea index, modified Rodnan skin score, and the University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal total score and subscores were associated with higher CESD-R score. Conclusion. In this single-center cross-sectional study, 16% of participants had significant depressive symptoms. Dyspnea, extent of skin involvement, and gastrointestinal symptoms were associated with depression symptoms. [ABSTRACT FROM AUTHOR]

Published
2023
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13. CONQUER Scleroderma: association of gastrointestinal tract symptoms in early disease with resource utilization

Author

Luebker, Sarah, primary, Frech, Tracy, additional, Assassi, Shervin, additional, Skaug, Brian, additional, Gordon, Jessica K, additional, Lakin, Kimberly, additional, Bernstein, Elana J, additional, Luo, Yiming, additional, Steen, Virginia D, additional, Shah, Ami A, additional, Hummers, Laura K, additional, Richardson, Carrie, additional, Moore, Duncan F, additional, Khanna, Dinesh, additional, Castelino, Flavia V, additional, Chung, Lorinda, additional, Kapoor, Puneet, additional, Hant, Faye N, additional, Shanmugam, Victoria K, additional, VanBuren, John M, additional, Alvey, Jessica, additional, Harding, Monica, additional, Shah, Ankoor, additional, Makol, Ashima, additional, Lebiedz-Odrobina, Dorota, additional, Thomas, Julie K, additional, Volkmann, Elizabeth R, additional, Molitor, Jerry A, additional, and Sandorfi, Nora, additional

Published
2023
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16. Additional file 1 of Expert consensus on the management of systemic sclerosis-associated interstitial lung disease

Author

Rahaghi, Franck F., Hsu, Vivien M., Kaner, Robert J., Mayes, Maureen D., Rosas, Ivan O., Saggar, Rajan, Steen, Virginia D., Strek, Mary E., Bernstein, Elana J., Bhatt, Nitin, Castelino, Flavia V., Chung, Lorinda, Domsic, Robyn T., Flaherty, Kevin R., Gupta, Nishant, Kahaleh, Bashar, Martinez, Fernando J., Morrow, Lee E., Moua, Teng, Patel, Nina, Shlobin, Oksana A., Southern, Brian D., Volkmann, Elizabeth R., and Khanna, Dinesh

Abstract

Additional file 1. Table S1. SSc-ILD Delphi Questionnaire 3 results. Table S2. SSc-ILD Delphi Supplemental Questionnaire 2 results

Published
2023
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18. E-Cigarette Use, Small Airway Fibrosis, and Constrictive Bronchiolitis

Author

Hariri, Lida P., primary, Flashner, Bess M., additional, Kanarek, David J., additional, O’Donnell, Walter J., additional, Soskis, Alyssa, additional, Ziehr, David R., additional, Frank, Angela, additional, Nandy, Sreyankar, additional, Berigei, Sarita R., additional, Sharma, Amita, additional, Mathisen, Douglas, additional, Keyes, Colleen M., additional, Lanuti, Michael, additional, Muniappan, Ashok, additional, O’Malley Shepard, Jo-Anne, additional, Mino-Kenudson, Mari, additional, Ly, Amy, additional, Hung, Yin P., additional, Castelino, Flavia V., additional, Ott, Harald C., additional, Medoff, Benjamin D., additional, and Christiani, David C., additional

Published
2022
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19. Computed Tomography of the Chest to Screen for Interstitial Lung Disease in Patients With Systemic Sclerosis at Expert Scleroderma Centers in the United States

Author

Bernstein, Elana J., primary, Assassi, Shervin, additional, Castelino, Flavia V., additional, Chung, Lorinda, additional, Correia, Chase, additional, Evnin, Luke B., additional, Frech, Tracy M., additional, Gordon, Jessica K., additional, Skaug, Brian A., additional, Hant, Faye N., additional, Hummers, Laura K., additional, Sandorfi, Nora, additional, Shah, Ami A., additional, Shanmugam, Victoria K., additional, Steen, Virginia D., additional, and Khanna, Dinesh, additional

Published
2022
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21. Baseline characteristics of systemic sclerosis patients with restrictive lung disease in a multi‐center US‐based longitudinal registry

Author

Castelino, Flavia V., primary, VanBuren, John M., additional, Startup, Emily, additional, Assassi, Shervin, additional, Bernstein, Elana J., additional, Chung, Lorinda, additional, Correia, Chase, additional, Evnin, Luke B., additional, Frech, Tracy M., additional, Gordon, Jessica K., additional, Hant, Faye N., additional, Hummers, Laura K., additional, Khanna, Dinesh, additional, Sandorfi, Nora, additional, Shah, Ami A., additional, Shanmugam, Victoria K., additional, and Steen, Virginia, additional

Published
2021
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25. Predictive Significance of Serum Interferon‐Inducible Protein Score for Response to Treatment in Systemic Sclerosis–Related Interstitial Lung Disease

Author

Assassi, Shervin, primary, Li, Ning, additional, Volkmann, Elizabeth R., additional, Mayes, Maureen D., additional, Rünger, Dennis, additional, Ying, Jun, additional, Roth, Michael D., additional, Hinchcliff, Monique, additional, Khanna, Dinesh, additional, Frech, Tracy, additional, Clements, Philip J., additional, Furst, Daniel E., additional, Goldin, Jonathan, additional, Bernstein, Elana J., additional, Castelino, Flavia V., additional, Domsic, Robyn T., additional, Gordon, Jessica K., additional, Hant, Faye N., additional, Shah, Ami A., additional, Shanmugam, Victoria K., additional, Steen, Virginia D., additional, Elashoff, Robert M., additional, and Tashkin, Donald P., additional

Published
2021
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27. Abatacept in Early Diffuse Cutaneous Systemic Sclerosis - Results of a Phase 2 Investigator-Initiated, Multicenter, Double-Blind Randomized Placebo-Controlled Trial

Author

Khanna, Dinesh, Spino, Cathie, Johnson, Sindhu, Chung, Lorinda, Whitfield, Michael L, Denton, Christopher P, Berrocal, Veronica, Franks, Jennifer, Mehta, Bhaven, Molitor, Jerry, Steen, Virginia D, Lafyatis, Robert, Simms, Robert W, Gill, Anna, Kafaja, Suzanne, Frech, Tracy M, Hsu, Vivien, Domsic, Robyn T, Pope, Janet E, Gordon, Jessica K, Mayes, Maureen D, Schiopu, Elena, Young, Amber, Sandorfi, Nora, Park, Jane, Hant, Faye N, Bernstein, Elana J, Chatterjee, Soumya, Castelino, Flavia V, Ajam, Ali, Wang, Yue, Wood, Tammara, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Singer, Ora, Bush, Erica, Fox, David A, Furst, Daniel E, University of Zurich, and Khanna, Dinesh

Subjects
2403 Immunology, 2745 Rheumatology, 10051 Rheumatology Clinic and Institute of Physical Medicine, 2723 Immunology and Allergy, 610 Medicine & health
Published
2020
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32. Does hand involvement in systemic sclerosis limit completion of patient-reported outcome measures?

Author

Frech, Tracy M., primary, VanBuren, John M., additional, Startup, Emily, additional, Assassi, Shervin, additional, Bernstein, Elana J., additional, Castelino, Flavia V., additional, Chung, Lorinda, additional, Correia, Chase, additional, Gordon, Jessica K., additional, Hant, Faye N., additional, Hummers, Laura, additional, Khanna, Dinesh, additional, Sandorfi, Nora, additional, Shah, Ami A., additional, Shanmugam, Victoria K., additional, Steen, Virginia, additional, and Evnin, Luke, additional

Published
2020
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33. Calcinosis is associated with ischemic manifestations and increased disability in patients with systemic sclerosis

Author

Valenzuela, Antonia, primary, Baron, Murray, additional, Rodriguez-Reyna, Tatiana S., additional, Proudman, Susanna, additional, Khanna, Dinesh, additional, Young, Amber, additional, Hinchcliff, Monique, additional, Steen, Virginia, additional, Gordon, Jessica, additional, Hsu, Vivien, additional, Castelino, Flavia V., additional, Schoenfeld, Sara, additional, Li, Shufeng, additional, Wu, Joy Y., additional, Fiorentino, David, additional, and Chung, Lorinda, additional

Published
2020
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35. Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator‐Initiated, Multicenter, Double‐Blind, Randomized, Placebo‐Controlled Trial

Author

Khanna, Dinesh, primary, Spino, Cathie, additional, Johnson, Sindhu, additional, Chung, Lorinda, additional, Whitfield, Michael L., additional, Denton, Christopher P., additional, Berrocal, Veronica, additional, Franks, Jennifer, additional, Mehta, Bhavan, additional, Molitor, Jerry, additional, Steen, Virginia D., additional, Lafyatis, Robert, additional, Simms, Robert W., additional, Gill, Anna, additional, Kafaja, Suzanne, additional, Frech, Tracy M., additional, Hsu, Vivien, additional, Domsic, Robyn T., additional, Pope, Janet E., additional, Gordon, Jessica K., additional, Mayes, Maureen D., additional, Schiopu, Elena, additional, Young, Amber, additional, Sandorfi, Nora, additional, Park, Jane, additional, Hant, Faye N., additional, Bernstein, Elana J., additional, Chatterjee, Soumya, additional, Castelino, Flavia V., additional, Ajam, Ali, additional, Wang, Yue, additional, Wood, Tammara, additional, Allanore, Yannick, additional, Matucci‐Cerinic, Marco, additional, Distler, Oliver, additional, Singer, Ora, additional, Bush, Erica, additional, Fox, David A., additional, and Furst, Daniel E., additional

Published
2019
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36. Baseline characteristics of systemic sclerosis patients with restrictive lung disease in a multi‐center US‐based longitudinal registry.

Author

Castelino, Flavia V., VanBuren, John M., Startup, Emily, Assassi, Shervin, Bernstein, Elana J., Chung, Lorinda, Correia, Chase, Evnin, Luke B., Frech, Tracy M., Gordon, Jessica K., Hant, Faye N., Hummers, Laura K., Khanna, Dinesh, Sandorfi, Nora, Shah, Ami A., Shanmugam, Victoria K., and Steen, Virginia

Subjects
*SYSTEMIC scleroderma, *LUNG diseases, *INTERSTITIAL lung diseases, *VITAL capacity (Respiration), *MEDICAL research
Abstract

Aim: Interstitial lung disease (ILD) is the leading cause of disease‐related death in systemic sclerosis (SSc). Here, we assess baseline characteristics of SSc subjects with and without restrictive lung disease (RLD) in a multi‐center, US‐based registry. Methods: SSc patients within 5 years of disease onset were enrolled in the Collaborative National Quality and Efficacy Registry (CONQUER), a multi‐center US‐based registry of SSc study participants (age ≥ 18 years) enrolled at 13 expert centers. All subjects met 2013 American College of Rheumatology / European League Against Rheumatism criteria. Subjects with a pulmonary function test (PFT) at baseline before April 1, 2020 were included. High‐resolution computed tomography scan of the chest was not available to characterize ILD for all subjects. RLD was defined as forced vital capacity (FVC) <80% or total lung capacity (TLC) <80% predicted. Results: There were 160 (45%) SSc subjects characterized as having RLD. There was no significant difference in age, gender or disease duration. RLD subjects had a mean disease duration from date of first non‐Raynaud's symptom of 2.6 years and a mean FVC% predicted of 67% at baseline. In multivariable analysis, non‐White race, higher physician global health assessment and modified Medical Research Council (mMRC) dyspnea scores, were independently associated with RLD. In the subgroup of RLD subjects with ILD, ILD had a negative correlation with RNA polymerase III antibody. Conclusion: CONQUER is the largest, multi‐center, prospective cohort of early SSc patients in the US. Non‐White race was independently associated with RLD. In addition, 45% of CONQUER subjects already had RLD, highlighting the importance of screening for SSc‐ILD at initial diagnosis. [ABSTRACT FROM AUTHOR]

Published
2022
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38. Rituximab for interstitial pneumonia with autoimmune features at two medical centres.

Author

D'Silva, Kristin M, Ventura, Iazsmin Bauer, Bolster, Marcy B, Castelino, Flavia V, Sharma, Amita, Little, Brent P, Adegunsoye, Ayodeji, Strek, Mary E, Choi, Hyon, and Montesi, Sydney B

Subjects
PULMONARY fibrosis, RITUXIMAB, AUTOIMMUNE diseases
Abstract

Objectives Many patients with interstitial lung disease (ILD) have autoimmune manifestations but do not meet criteria for a systemic rheumatic disease. A subset meets criteria for interstitial pneumonia with autoimmune features (IPAF) and have ILD requiring therapy. We conducted a multicentre observational study to examine the use of rituximab (RTX) in IPAF. Methods Patients from Mass General Brigham (MGB) and University of Chicago Medicine (UCM) were included if they were ≥18 years old, met the 2015 classification criteria for IPAF and were treated with RTX. Clinical improvement was defined as improvement in four out of four domains at 1 year after RTX initiation: documented clinician global assessment; oxygen requirement; need for respiratory-related hospitalization; and survival. Results At MGB, 36 IPAF patients (mean age 61 years, 44% female) were treated with RTX. At 1 year, 18 (50%) were clinically improved, 12 (33%) were stable, and 6 (17%) died from progressive respiratory failure. At UCM, 14 IPAF patients (mean age 53 years, 71% female) were treated with RTX. At 1 year, eight (57%) were improved, two (14%) were stable, three (21%) died from progressive respiratory failure, and one (7%) was lost to follow-up. Two patients experienced minor infusion reactions, and two patients discontinued therapy owing to adverse events (infections). Conclusion In patients with IPAF treated with RTX at two medical centres, the majority (40 [80%]) demonstrated improvement/stability at 1 year. These findings call for prospective studies, including randomized clinical trials, to determine the risks, benefits and cost effectiveness of RTX in IPAF. [ABSTRACT FROM AUTHOR]

Published
2021
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39. Global skin gene expression analysis of early diffuse cutaneous systemic sclerosis shows a prominent innate and adaptive inflammatory profile

Author

Skaug, Brian, primary, Khanna, Dinesh, additional, Swindell, William R, additional, Hinchcliff, Monique E, additional, Frech, Tracy M, additional, Steen, Virginia D, additional, Hant, Faye N, additional, Gordon, Jessica K, additional, Shah, Ami A, additional, Zhu, Lisha, additional, Zheng, W Jim, additional, Browning, Jeffrey L, additional, Barron, Alexander M S, additional, Wu, Minghua, additional, Visvanathan, Sudha, additional, Baum, Patrick, additional, Franks, Jennifer M, additional, Whitfield, Michael L, additional, Shanmugam, Victoria K, additional, Domsic, Robyn T, additional, Castelino, Flavia V, additional, Bernstein, Elana J, additional, Wareing, Nancy, additional, Lyons, Marka A, additional, Ying, Jun, additional, Charles, Julio, additional, Mayes, Maureen D, additional, and Assassi, Shervin, additional

Published
2019
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40. Collaborative National Quality and Efficacy Registry (CONQUER) for Scleroderma: outcomes from a multicenter US-based systemic sclerosis registry

Author

Shanmugam, Victoria K., primary, Frech, Tracy M., additional, Steen, Virginia D., additional, Hummers, Laura K., additional, Shah, Ami A., additional, Bernstein, Elana J., additional, Khanna, Dinesh, additional, Gordon, Jessica K., additional, Castelino, Flavia V., additional, Chung, Lorinda, additional, Hant, Faye N., additional, Startup, Emily, additional, VanBuren, John M., additional, Evnin, Luke B., additional, and Assassi, Shervin, additional

Published
2019
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42. Barriers to and Facilitators of a Career as a Physician-Scientist Among Rheumatologists in the US: Career as a Rheumatology Physician-Scientist

Author

Muscal, Eyal, Makris, Una E., Golding, Amit, Ogdie, Alexis, Castelino, Flavia V., Angeles-Han, Sheila T., Barg, Frances K., Jiang, Yihui, Kim, Alfred H. J., Nelson, Amanda E., Kahlenberg, J. Michelle, and Shah, Ami A.

Subjects
education, health care economics and organizations, humanities
Abstract

To determine perceived barriers and facilitators to a career in rheumatology research, examine factors leading rheumatologists to leave an academic research career, and solicit ways to best support young physician-scientists.

Published
2015
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45. Autotaxin activity increases locally following lung injury, but is not required for pulmonary lysophosphatidic acid production or fibrosis

Author

Black, Katharine E., primary, Berdyshev, Evgeny, additional, Bain, Gretchen, additional, Castelino, Flavia V., additional, Shea, Barry S., additional, Probst, Clemens K., additional, Fontaine, Benjamin A., additional, Bronova, Irina, additional, Goulet, Lance, additional, Lagares, David, additional, Ahluwalia, Neil, additional, Knipe, Rachel S., additional, Natarajan, Viswanathan, additional, and Tager, Andrew M., additional

Published
2016
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46. Barriers and Facilitators of Mentoring for Trainees and Early Career Investigators in Rheumatology Research: Current State, Identification of Needs, and Road Map to an Inter-Institutional Adult Rheumatology Mentoring Program.

Author

Ogdie, Alexis, Sparks, Jeffrey A., Angeles‐Han, Sheila T., Bush, Kathleen, Castelino, Flavia V., Golding, Amit, Jiang, Yihui, Kahlenberg, J. Michelle, Kim, Alfred H. J., Lee, Yvonne C., Machireddy, Kirthi, Ombrello, Michael J., Shah, Ami A., Wallace, Zachary S., Nigrovic, Peter A., Makris, Una E., for the American College of Rheumatology Early Career Investigator Subcommittee of the Committee on Research, Angeles-Han, Sheila T, and American College of Rheumatology Early Career Investigator Subcommittee of the Committee on Research

Abstract

Objective: To determine perceived barriers and facilitators to effective mentoring for early career rheumatology investigators and to develop a framework for an inter-institutional mentoring program.Methods: Focus groups or interviews with rheumatology fellows, junior faculty, and mentors were conducted, audiorecorded, and transcribed. Content analysis was performed using NVivo software. Themes were grouped into categories (e.g., mentor-mentee relationship, barriers, and facilitators of a productive relationship). Rheumatology fellows and early career investigators were also surveyed nationwide to identify specific needs to be addressed through an inter-institutional mentoring program.Results: Twenty-five individuals participated in focus groups or interviews. Attributes of the ideal mentee-mentor relationship included communication, accessibility, regular meetings, shared interests, aligned goals, and mutual respect. The mentee should be proactive, efficient, engaged, committed, focused, accountable, and respectful of the mentor's time. The mentor should support/promote the mentee, shape the mentee's goals and career plan, address day-to-day questions, provide critical feedback, be available, and have team leadership skills. Barriers included difficulty with career path navigation, gaining independence, internal competition, authorship, time demands, funding, and work-life balance. Facilitators of a successful relationship included having a diverse network of mentors filling different roles, mentor-mentee relationship management, and confidence. Among 187 survey respondents, the primary uses of an inter-institutional mentoring program were career development planning and oversight, goal-setting, and networking.Conclusions: In this mixed-methods study, tangible factors for optimizing the mentor-mentee relationship were identified and will inform the development of an adult rheumatology inter-institutional mentoring program. [ABSTRACT FROM AUTHOR]

Published
2018
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49. Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials

Author

Saketkoo, Lesley Ann, primary, Mittoo, Shikha, additional, Huscher, Dörte, additional, Khanna, Dinesh, additional, Dellaripa, Paul F, additional, Distler, Oliver, additional, Flaherty, Kevin R, additional, Frankel, Sid, additional, Oddis, Chester V, additional, Denton, Christopher P, additional, Fischer, Aryeh, additional, Kowal-Bielecka, Otylia M, additional, LeSage, Daphne, additional, Merkel, Peter A, additional, Phillips, Kristine, additional, Pittrow, David, additional, Swigris, Jeffrey, additional, Antoniou, Katerina, additional, Baughman, Robert P, additional, Castelino, Flavia V, additional, Christmann, Romy B, additional, Christopher-Stine, Lisa, additional, Collard, Harold R, additional, Cottin, Vincent, additional, Danoff, Sonye, additional, Highland, Kristin B, additional, Hummers, Laura, additional, Shah, Ami A, additional, Kim, Dong Soon, additional, Lynch, David A, additional, Miller, Frederick W, additional, Proudman, Susanna M, additional, Richeldi, Luca, additional, Ryu, Jay H, additional, Sandorfi, Nora, additional, Sarver, Catherine, additional, Wells, Athol U, additional, Strand, Vibeke, additional, Matteson, Eric L, additional, Brown, Kevin K, additional, and Seibold, James R, additional

Published
2013
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50. Reconciling Healthcare Professional and Patient Perspectives in the Development of Disease Activity and Response Criteria in Connective Tissue Disease–related Interstitial Lung Diseases

Author

Saketkoo, Lesley Ann, Mittoo, Shikha, Frankel, Sid, LeSage, Daphne, Sarver, Catherine, Phillips, Kristine, Strand, Vibeke, Matteson, Eric L., Baughman, Robert P., Brown, Kevin K., Christmann, Romy B., Dellaripa, Paul, Denton, Christopher P., Distler, Oliver, Fischer, Aryeh, Flaherty, Kevin, Huscher, Dörte, Khanna, Dinesh, Kowal-Bielecka, Otylia, Merkel, Peter A., Oddis, Chester V., Pittrow, David, Sandorfi, Nora, Seibold, James R., Swigris, Jeffrey, Wells, Athol, Antoniou, Katerina, Castelino, Flavia V., Christopher-Stine, Lisa, Collard, Harold R., Cottin, Vincent, Danoff, Sonye, Hedlund, Robert, Highland, Kristin B., Hummers, Laura, Lynch, David A., Kim, Dong Soon, Ryu, Jay H., Christopher-Stine, Lisa, Miller, Frederick W., Nichols, Karen, Proudman, Susanna M., Richeldi, Luca, Shah, Ami A., van den Assum, Pieter, Aggarwal, Rohit, Ainslie, Gillian, Alkassab, Firas, Allanore, Yannick, Anderson, Marina E., Andonopoulos, Andrew P., Antin-Ozerkis, Danielle, Antoniou, Katerina, Arrobas, Ana, Ascherman, Dana P., Assassi, Shervin, Baron, Murray, Bathon, Joan M., Baughman, Robert P., Behr, Juergen, Beretta, Lorenzo, Bingham, Clifton O., Binnie, Matthew, Birring, Surinder S., Boin, Francesco, Bongartz, Tim, Bourdin, Arnaud, Bouros, Demosthenes, Brasington, Richard, Bresser, Paul, Brown, Kevin K., Buch, Maya H., Burge, P. Sherwood, Carmona, Loreto, Castelino, Flavia V., Carreira, Patricia E., Carvalho, Carlos R.R., Catoggio, Luis J., Chan, Kevin M., Chapman, Jeffrey, Chatterjee, Soumya, Christmann, Romy B., Christopher-Stine, Lisa, Chua, Felix, Chung, Lorinda, Conron, Matthew, Corte, Tamera, Cosgrove, Gregory, Costabel, Ulrich, Cottin, Vincent, Cox, Gerard, Crestani, Bruno, Crofford, Leslie J., Csuka, Mary E., Curbelo, Pablo, Czirják, László, Daniil, Zoe, Danoff, Sonye, D’Arsigny, Christine L., Davis, Gerald S., de Andrade, Joao A., Dellaripa, Paul F., De Vuyst, Paul, Dempsey, Owen J., Denton, Christopher P., Derk, Chris T., Distler, Jörg, Distler, Oliver, Dixon, William G., Downey, Gregory, Doyle, Mittie K., Drent, Marjolein, Durairaj, Lakshmi, Emery, Paul, Espinoza, Luis R., Farge, Dominique, Fathi, Maryam, Fell, Charlene D., Fessler, Barri J., Fischer, Aryeh, Fitzgerald, John E., Flaherty, Kevin R., Foeldvari, Ivan, Fox, George A., Frech, Tracy M., Freitas, Sara, Furst, Daniel E., Gabrielli, Armando, García-Vicuña, Rosario, Georgiev, Ognian B., Gerbino, Anthony, Gillisen, Adrian, Gladman, Dafna D., Glassberg, Marilyn, Gochuico, Bernadette R., Gogali, Athena, Goh, Nicole S., Goldberg, Avram, Goldberg, Hilary J., Gourley, Mark F., Griffing, Leroy, Grutters, Jan C., Gunnarsson, Ragnar, Hachulla, Eric, Hall, Frances C., Harari, Sergio, Herrick, Ariane L., Herzog, Erica L., Hesselstrand, Roger, Highland, Kristin, Hirani, Nikhil, Hodgson, Ulla, Hollingsworth, Helen M., Homer, Robert J., Hoyles, Rachel K., Hsu, Vivien M., Hubbard, Richard B., Hummers, Laura, Hunzelmann, Nicolas, Huscher, Dörte, Isasi, Maria Eloisa, Isasi, Elida Susana, Jacobsen, Soren, Jimenez, Sergio A., Johnson, Sindhu R., Jones, Christine H., Kahaleh, Bashar, Kairalla, Ronaldo A., Kalluri, Meena, Kalra, Sanjay, Kaner, Robert J., Khanna, Dinesh, Kim, Dong Soon, Kinder, Brent W., Kiter, Goksel, Klingsberg, Ross C., Kokosi, Maria, Kolb, Martin R.J., Kowal-Bielecka, Otylia M., Kur-Zalewska, Joanna, Kuwana, Masataka, Lake, Fiona R., Lally, Edward V., Lasky, Joseph A., Laurindo, Ileda M., Able, Lawrence, Lee, Peter, Leonard, Colm T., Lien, Dale C., Limper, Andrew H., Liossis, Stamatis-Nick C., Lohr, Kristine M., Loyd, James E., Lundberg, Ingrid E., Mageto, Yolanda N., Maher, Toby M., Mahmud, Tafazzul H., Manganas, Helene, Marie, Isabelle, Marras, Theodore K., Martinez, José Antônio Baddini, Martinez, Fernando J., Mathieu, Alessandro, Matucci-Cerinic, Marco, Mayes, Maureen D., McKown, Kevin M., Medsger, Thomas A., Meehan, Richard T., Mendes, Ana Cristina, Merkel, Peter A., Meyer, Keith C., Millar, Ann B., Miller, Frederick W., Moğulkoç, Nesrin, Molitor, Jerry A., Morais, António, Mouthon, Luc, Müller, Veronika, Müller-Quernheim, Joachim, Nadashkevich, Oleg, Nador, Roland, Nash, Peter, Nathan, Steven D., Navarro, Carmen, Neves, Sofia, Noth, Imre, Nunes, Hilario, Oddis, Chester V., Olson, Amy L., Opitz, Christian F., Padilla, Maria, Pappas, Dimitrios, Parfrey, Helen, Pego-Reigosa, José M., Pereira, Carlos A.C., Perez, Rafael, Phillips, Kristine, Pittrow, David, Pope, Janet E., Porter, Joanna C., Proudman, Susanna M., Renzoni, Elisabeth A., Richeldi, Luca, Riemekasten, Gabriela, Riley, David J., Rischmueller, Maureen, Rodriguez-Reyna, Tatiana S., Rojas-Serrano, J., Roman, Jesse, Rosen, Glenn D., Rossman, Milton, Rothfield, Naomi, Ryu, Jay H., Sahn, Steven A., Sandorfi, Nora, Sanduzzi, Alessandro, Scholand, Mary Beth, Seibold, James R., Selman, Moises, Senécal, Jean-Luc, Seo, Philip, Shah, Ami, Silver, Richard M., Solomon, Joshua J., Steen, Virginia, Stevens, Wendy, Strange, Charlie, Sussman, Robert, Sutton, Evelyn D., Sweiss, Nadera J., Swigris, Jeffrey, Tornling, Göran, Tzelepis, George E., Undurraga, Alvaro, Vacca, Allessandra, Vancheri, Carlo, Varga, Janos, Veale, Douglas J., Volkov, Suncica, Walker, Ulrich A., Wells, Athol U., Wencel, Mark, Wesselius, Lewis J., Wickremasinghe, Melissa, Wilcox, Pearce, Wilsher, Margaret L., Wollheim, Frank A., Wuyts, Wim A., Yung, Gordon, Zanon, Pietro, Zappala, Christopher J., Groshong, Steve D., Leslie, Kevin O., Myers, Jeffrey L., Padera, Robert F., Desai, Sujal R., Goldin, Jonathan, Kazerooni, Ella A., Klein, Jeffrey S., Lynch, David A., and Keen, Kevin J.

Abstract

Interstitial lung diseases (ILD), including those related to connective tissue disease (CTD), and idiopathic pulmonary fibrosis (IPF) carry high morbidity and mortality. Great efforts are under way to develop and investigate meaningful treatments in the context of clinical trials. However, efforts have been challenged by a lack of validated outcome measures and by inconsistent use of measures in clinical trials. Lack of consensus has fragmented effective use of strategies in CTD-ILD and IPF, with a history of resultant difficulties in obtaining agency approval of treatment interventions. Until recently, the patient perspective to determine domains and outcome measures in CTD-ILD and IPF had never been applied. Efforts described here demonstrate unequivocally the value and influence of patient involvement on core set development. Regarding CTD-ILD, this is the first OMERACT working group to directly address a manifestation/comorbidity of a rheumatic disease (ILD) as well as a disease not considered rheumatic (IPF). The OMERACT 11 proceedings of the CTD-ILD Working Group describe the forward and lateral process to include both the medical and patient perspectives in the urgently needed identification of a core set of preliminary domains and outcome measures in CTD-ILD and IPF.

Published
2014
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