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Article ; Online: Management of systemic sclerosis: the first five years.

Roofeh, David / Khanna, Dinesh

2020 Volume 32, Issue 3, Page(s) 228–237

Abstract: Purpose of review: This review provides a risk-stratified and evidence-based management for subsets of systemic sclerosis (SSc) patients in the first five years from disease onset.: Recent findings: Cardiopulmonary disease remains the primary cause ... ...

Abstract	Purpose of review: This review provides a risk-stratified and evidence-based management for subsets of systemic sclerosis (SSc) patients in the first five years from disease onset. Recent findings: Cardiopulmonary disease remains the primary cause of mortality in SSc patients. Morbidity and mortality in SSc-associated pulmonary arterial hypertension have improved with combination treatment, in either an upfront or sequential treatment pattern. Traditional therapies for interstitial lung disease (SSc-ILD) have targeted those with clinically significant and progressive ILD with immunosuppression. New data suggest a possible paradigm shift, introducing immunosuppressive therapy to patients before they develop clinically significant or progressive ILD. The year 2019 saw the approval of the first FDA-approved therapy for SSc-associated interstitial lung disease, using an antifibrotic agent previously approved for idiopathic pulmonary fibrosis. To date, only autologous hematopoietic stem cell transplant has demonstrated a mortality benefit for SSc-ILD, albeit in a narrow spectrum of SSc-ILD patients. Summary: SSc is a highly heterogeneous autoimmune disease typified by varying clinical trajectories. Its management may be stratified within the first five years by subclassifying patients based on factors that have important prognostic significance: skin distribution and autoantibody status.
MeSH term(s)	Hematopoietic Stem Cell Transplantation ; Humans ; Immunosuppressive Agents/therapeutic use ; Lung Diseases, Interstitial/drug therapy ; Lung Diseases, Interstitial/etiology ; Lung Diseases, Interstitial/therapy ; Prognosis ; Scleroderma, Systemic/complications ; Scleroderma, Systemic/drug therapy ; Scleroderma, Systemic/therapy
Chemical Substances	Immunosuppressive Agents
Language	English
Publishing date	2020-03-23
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	1045317-9
ISSN	1531-6963 ; 1040-8711
ISSN (online)	1531-6963
ISSN	1040-8711
DOI	10.1097/BOR.0000000000000711
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Article ; Online: Treatment for systemic sclerosis-associated interstitial lung disease.

Roofeh, David / Lescoat, Alain / Khanna, Dinesh

Current opinion in rheumatology

2021 Volume 33, Issue 3, Page(s) 240–248

Abstract: Purpose of review: This review provides an overview of the current treatments for systemic sclerosis-interstitial lung disease (SSc-ILD) and proposes a conceptual framework for disease management with case scenarios.: Recent findings: Broad treatment ...

Abstract	Purpose of review: This review provides an overview of the current treatments for systemic sclerosis-interstitial lung disease (SSc-ILD) and proposes a conceptual framework for disease management with case scenarios. Recent findings: Broad treatment categories include traditional cytotoxic therapies, biologic disease-modifying rheumatic drugs, antifibrotic agents, autologous hematopoietic stem cell transplant, and lung transplantation. The optimal use of each option varies depending on SSc-ILD severity, progression, and comorbidities of individual patients. A high-quality randomized controlled trial demonstrated nintedanib's ability to retard decline of lung function in patients with limited and diffuse cutaneous disease, with established ILD. Tocilizumab, recently approved by the FDA, provides a unique intervention in those with early SSc associated with ILD with elevated acute-phase reactants: two well designed trials showed lung function preservation in phase 2 and phase 3 trials. Summary: Stratifying patients based on key SSc-ILD characteristics (e.g. severity, risk of progression, comorbid disease presentation) may provide a useful guide for practitioners treating SSc-ILD.
MeSH term(s)	Humans ; Lung Diseases, Interstitial/etiology ; Lung Diseases, Interstitial/therapy ; Randomized Controlled Trials as Topic ; Scleroderma, Systemic/complications
Language	English
Publishing date	2021-03-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1045317-9
ISSN	1531-6963 ; 1040-8711
ISSN (online)	1531-6963
ISSN	1040-8711
DOI	10.1097/BOR.0000000000000795
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Article ; Online: Emerging drugs for the treatment of scleroderma: a review of recent phase 2 and 3 trials.

Roofeh, David / Lescoat, Alain / Khanna, Dinesh

Expert opinion on emerging drugs

2020 Volume 25, Issue 4, Page(s) 455–466

Abstract: Introduction: Systemic sclerosis (SSc) has the highest case-specific mortality of all connective tissue diseases. Its underlying disease mechanism affects several organs and remains incompletely understood. Ongoing work clarifying its etiopathogenesis ... ...

Abstract	Introduction: Systemic sclerosis (SSc) has the highest case-specific mortality of all connective tissue diseases. Its underlying disease mechanism affects several organs and remains incompletely understood. Ongoing work clarifying its etiopathogenesis is helping to develop targeted therapy. Areas covered: Several clinical trials have evaluated the safety and efficacy of agents targeting different mechanisms of this disease. This review article reviews those mechanisms and surveys four key recent phase II or III clinical trials that are contributing to the landscape of SSc therapy. The reported trials primarily focus on patients with systemic sclerosis in the early phase of disease. Expert opinion: Traditional therapies for SSc center on immunosuppressive and cytotoxic agents. A new cadre of therapies is borne from improved understandings of SSc pathobiology and target the inflammatory-fibrotic pathways. Scleroderma trials have entered the initial phase of personalized medicine, recognizing molecular subsets that will improve upon cohort enrichment and maximize the measurable benefit of future therapies.
MeSH term(s)	Animals ; Drug Design ; Humans ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/pharmacology ; Molecular Targeted Therapy ; Precision Medicine ; Scleroderma, Systemic/drug therapy ; Scleroderma, Systemic/mortality ; Scleroderma, Systemic/physiopathology
Chemical Substances	Immunosuppressive Agents
Language	English
Publishing date	2020-10-26
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	2061369-6
ISSN	1744-7623 ; 1472-8214
ISSN (online)	1744-7623
ISSN	1472-8214
DOI	10.1080/14728214.2020.1836156
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Article ; Online: Management of systemic sclerosis-associated interstitial lung disease.

Roofeh, David / Jaafar, Sara / Vummidi, Dharshan / Khanna, Dinesh

Current opinion in rheumatology

2019 Volume 31, Issue 3, Page(s) 241–249

Abstract: Purpose of review: To review the recently published data and provide a practical overview for management of systemic sclerosis-interstitial lung disease (SSc-ILD).: Recent findings: Published evidence shows considerable practitioner variability in ... ...

Abstract	Purpose of review: To review the recently published data and provide a practical overview for management of systemic sclerosis-interstitial lung disease (SSc-ILD). Recent findings: Published evidence shows considerable practitioner variability in screening patients for ILD. Recent published data support use of cyclophosphamide or mycophenolate mofetil as first-line treatment of SSc-ILD. For patients not responding to first-line therapies, consideration is given to rituximab as rescue therapy. Recent trials of hematopoietic autologous stem cell transplantation have demonstrated benefit in patients with progressive SSc-ILD. Antifibrotic agents are approved in idiopathic pulmonary fibrosis; studies with antifibrotics are underway for SSc-ILD. Summary: The specter of rapidly progressive lung disease requires clinicians to risk stratify patients according to known predictors for progression and rigorously monitor for symptoms and advancing disease. The abovementioned therapies promise improved efficacy and favorable side-effect profiles compared to cyclophosphamide.
MeSH term(s)	Cyclophosphamide/therapeutic use ; Disease Progression ; Hematopoietic Stem Cell Transplantation ; Humans ; Immunosuppressive Agents/therapeutic use ; Lung Diseases, Interstitial/drug therapy ; Lung Diseases, Interstitial/etiology ; Lung Diseases, Interstitial/therapy ; Mycophenolic Acid/therapeutic use ; Rituximab/therapeutic use ; Scleroderma, Systemic/complications ; Treatment Outcome
Chemical Substances	Immunosuppressive Agents ; Rituximab (4F4X42SYQ6) ; Cyclophosphamide (8N3DW7272P) ; Mycophenolic Acid (HU9DX48N0T)
Language	English
Publishing date	2019-03-14
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	1045317-9
ISSN	1531-6963 ; 1040-8711
ISSN (online)	1531-6963
ISSN	1040-8711
DOI	10.1097/BOR.0000000000000592
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Article ; Online: Therapeutic Approaches to Systemic Sclerosis: Recent Approvals and Future Candidate Therapies.

Lescoat, Alain / Roofeh, David / Kuwana, Masataka / Lafyatis, Robert / Allanore, Yannick / Khanna, Dinesh

Clinical reviews in allergy & immunology

2021 Volume 64, Issue 3, Page(s) 239–261

Abstract: Systemic sclerosis is the rheumatic disease with the highest individual mortality. The severity of the disease is determined by the extent of fibrotic changes to cutaneous and internal organ tissues, the most life-threatening visceral manifestations ... ...

Abstract	Systemic sclerosis is the rheumatic disease with the highest individual mortality. The severity of the disease is determined by the extent of fibrotic changes to cutaneous and internal organ tissues, the most life-threatening visceral manifestations being interstitial lung disease, SSc-associated-pulmonary arterial hypertension and myocardial involvement. The heterogeneity of the disease has initially hindered the design of successful clinical trials, but considerations on classification criteria have improved patient selection in trials, allowing the identification of more homogeneous groups of patients based on progressive visceral manifestations or the extent of skin involvement with a focus of patients with early disease. Two major subsets of systemic sclerosis are classically described: limited cutaneous systemic sclerosis characterized by distal skin fibrosis and the diffuse subset with distal and proximal skin thickening. Beyond this dichotomic subgrouping of systemic sclerosis, new phenotypic considerations based on antibody subtypes have provided a better understanding of the heterogeneity of the disease, anti-Scl70 antibodies being associated with progressive interstitial lung disease regardless of cutaneous involvement. Two targeted therapies, tocilizumab (a monoclonal antibody targeting interleukin-6 receptors (IL-6R)) and nintedanib (a tyrosine kinase inhibitor), have recently been approved by the American Food & Drug Administration to limit the decline of lung function in patients with SSc-associated interstitial lung disease, demonstrating that such better understanding of the disease pathogenesis with the identification of key targets can lead to therapeutic advances in the management of some visceral manifestations of the disease. This review will provide a brief overview of the pathogenesis of SSc and will present a selection of therapies recently approved or evaluated in this context. Therapies evaluated and approved in SSc-ILD will be emphasized and a review of recent phase II trials in diffuse cutaneous systemic sclerosis will be proposed. We will also discuss selected therapeutic pathways currently under investigation in systemic sclerosis that still lack clinical data in this context but that may show promising results in the future based on preclinical data.
MeSH term(s)	Humans ; Scleroderma, Systemic/drug therapy ; Lung Diseases, Interstitial/drug therapy ; Lung Diseases, Interstitial/etiology ; Skin/pathology
Language	English
Publishing date	2021-09-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1239045-8
ISSN	1559-0267 ; 1080-0549
ISSN (online)	1559-0267
ISSN	1080-0549
DOI	10.1007/s12016-021-08891-0
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Zs.A 1844: Show issues

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Article ; Online: Management of systemic sclerosis-associated interstitial lung disease in the current era.

Amjadi, Sogol Sara / Roofeh, David / Namas, Rajaie / Khanna, Dinesh

International journal of rheumatic diseases

2019 Volume 23, Issue 2, Page(s) 137–139

MeSH term(s)	Disease Management ; Female ; Humans ; Lung Diseases, Interstitial/etiology ; Lung Diseases, Interstitial/therapy ; Male ; Scleroderma, Systemic/complications
Language	English
Publishing date	2019-09-19
Publishing country	England
Document type	Editorial
ZDB-ID	2426924-4
ISSN	1756-185X ; 1756-1841
ISSN (online)	1756-185X
ISSN	1756-1841
DOI	10.1111/1756-185X.13799
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Article ; Online: Treatment of systemic sclerosis-associated interstitial lung disease: Lessons from clinical trials.

Roofeh, David / Distler, Oliver / Allanore, Yannick / Denton, Christopher P / Khanna, Dinesh

Journal of scleroderma and related disorders

2020 Volume 5, Issue 2 Suppl, Page(s) 61–71

Abstract: Systemic sclerosis-associated interstitial lung disease remains a leading cause of mortality. Despite decades of clinical trials, the treatment effects of disease modifying anti-rheumatic drugs continue to be modest and there remains a great need for ... ...

Abstract	Systemic sclerosis-associated interstitial lung disease remains a leading cause of mortality. Despite decades of clinical trials, the treatment effects of disease modifying anti-rheumatic drugs continue to be modest and there remains a great need for therapies that attenuate and hopefully ameliorate parenchymal lung disease. In this review, we highlight the key clinical trials that have shaped the management strategies employed by the authors, providing their strength of recommendation based on level of evidence. We also review lessons learned in more recent years, suggesting a benefit in targeting patients with subclinical interstitial lung disease with high risk for progression early in the disease course, as well as the benefit seen in a large clinical trial leading to the first Food and Drug Administration-approved treatment for systemic sclerosis-associated interstitial lung disease. These lessons come in a context of heterogeneity of patient populations and response to therapy, as well as the inherent constraints of time-limited studies to detect meaningful outcomes for patients.
Language	English
Publishing date	2020-03-05
Publishing country	England
Document type	Journal Article
ISSN	2397-1991
ISSN (online)	2397-1991
DOI	10.1177/2397198320903208
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Article ; Online: Domains and outcome measures for the assessment of limited cutaneous systemic sclerosis: a scoping review protocol.

Lescoat, Alain / Roofeh, David / Townsend, Whitney / Hughes, Michael / Sandler, Robert D / Zimmermann, François / Pauling, John D / Buch, Maya H / Khanna, Dinesh

BMJ open

2021 Volume 11, Issue 3, Page(s) e044765

Abstract: Introduction: Limited cutaneous systemic sclerosis (lcSSc) is the most frequent subset of systemic sclerosis. Despite this, lcSSc is not the major focus of clinical studies. The lack of interventional studies in lcSSc is due, in part, to a paucity of ... ...

Abstract	Introduction: Limited cutaneous systemic sclerosis (lcSSc) is the most frequent subset of systemic sclerosis. Despite this, lcSSc is not the major focus of clinical studies. The lack of interventional studies in lcSSc is due, in part, to a paucity of relevant outcome measures to effectively evaluate this subset. A combined response index dedicated to lcSSc would facilitate development of well-designed trials and approval of new drugs. The objective of this scoping review is to perform a broad and comprehensive identification of the outcome measures (core set items) within relevant domains, which have been used so far to assess lcSSc. Methods and analysis: The planned scoping review will be based on the approach proposed by Arksey Ethics and dissemination: No ethical approval is required for this study. The results will be submitted to an international peer-reviewed journal and scientific conferences, informing the discussion on which items should be included in a combined response index dedicated to lcSSc (the CRISTAL project: Combined Response Index for Scleroderma Trial Assessing lcSSc).
MeSH term(s)	Humans ; Outcome Assessment, Health Care ; Peer Review ; Research Design ; Review Literature as Topic ; Scleroderma, Systemic/therapy ; Systematic Reviews as Topic
Language	English
Publishing date	2021-03-11
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2020-044765
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Article: Hospitalisations related to systemic sclerosis and the impact of interstitial lung disease. Analysis of patients hospitalised at the University of Michigan, USA.

Sankar, Shobana / Habib, Mirette / Jaafar, Sara / Nagaraja, Vivek / Roofeh, David / Young, Amber / Huang, Suiyuan / Khanna, Dinesh

Clinical and experimental rheumatology

2021 Volume 39 Suppl 131, Issue 4, Page(s) 43–51

Abstract: Objectives: To determine the primary reason for hospitalisations in systemic sclerosis (SSc) and impact of underlying interstitial lung disease (ILD) in a tertiary scleroderma centre.: Methods: A retrospective analysis on a subset of a scleroderma ... ...

Abstract	Objectives: To determine the primary reason for hospitalisations in systemic sclerosis (SSc) and impact of underlying interstitial lung disease (ILD) in a tertiary scleroderma centre. Methods: A retrospective analysis on a subset of a scleroderma cohort from 2011-2019 was performed to assess causes for hospitalisations and mortality. A chart review was performed to extract demographics, primary reason for hospitalisation and inpatient mortality. Admissions were classified as SSc (if hospitalisation reason was related to primary organ dysfunction) and non-SSc related causes. Results: The mean age of the cohort was 53.1 years, 78% were women, and the mean disease duration was 5.2 years. Among 484 patients, 182 (37.6%) were admitted for a total of 634 admissions. In 382 SSc-related admissions, pulmonary hypertension (12.0%) and gastrointestinal dysmotility (11.0%), were major causes of urgent admissions; management of digital vasculopathy (26.1%) was the major reason for elective admissions. In 252 non-SSc related admissions, infection (respiratory:11.5%, skin and soft tissue: 6.3%) was the major reason for urgent admissions, and elective surgery (21.4%) was the major reason for elective admissions. We found 65% of all patients had underlying ILD and a greater proportion of patients with ILD were hospitalised (122 patients). Overall inpatient mortality was 9.3% and the leading cause for mortality was progressive pulmonary hypertension. Conclusions: Among a large cohort of SSc patients who are followed at a tertiary scleroderma centre, 37.6 % had hospital admissions, while worsening pulmonary hypertension, ILD, cardiac involvement and infectious complications were the major cause of mortality and morbidity.
MeSH term(s)	Female ; Hospitalization ; Humans ; Hypertension, Pulmonary/epidemiology ; Hypertension, Pulmonary/etiology ; Hypertension, Pulmonary/therapy ; Lung Diseases, Interstitial/diagnosis ; Lung Diseases, Interstitial/epidemiology ; Lung Diseases, Interstitial/therapy ; Middle Aged ; Retrospective Studies ; Scleroderma, Systemic/diagnosis ; Scleroderma, Systemic/epidemiology ; Scleroderma, Systemic/therapy
Language	English
Publishing date	2021-03-10
Publishing country	Italy
Document type	Journal Article
ZDB-ID	605886-3
ISSN	1593-098X ; 0392-856X
ISSN (online)	1593-098X
ISSN	0392-856X
DOI	10.55563/clinexprheumatol/9ivp9g
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Zs.A 2002: Show issues

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Article ; Online: Tocilizumab Prevents Progression of Early Systemic Sclerosis-Associated Interstitial Lung Disease.

Roofeh, David / Lin, Celia J F / Goldin, Jonathan / Kim, Grace Hyun / Furst, Daniel E / Denton, Christopher P / Huang, Suiyuan / Khanna, Dinesh

Arthritis & rheumatology (Hoboken, N.J.)

2021 Volume 73, Issue 7, Page(s) 1301–1310

Abstract: Objective: Tocilizumab (TCZ) has demonstrated lung function preservation in 2 randomized controlled trials in early systemic sclerosis (SSc). This effect has yet to be characterized in terms of radiographically evident quantitative lung involvement. We ... ...

Abstract	Objective: Tocilizumab (TCZ) has demonstrated lung function preservation in 2 randomized controlled trials in early systemic sclerosis (SSc). This effect has yet to be characterized in terms of radiographically evident quantitative lung involvement. We undertook this study to assess the impact of TCZ on lung function preservation in a post hoc analysis, stratifying treatment arms according to the degree of lung involvement. Methods: The focuSSced trial was a phase III randomized placebo-controlled trial of TCZ in patients with SSc and progressive skin disease. Participants underwent baseline and serial spirometry along with high-resolution chest computed tomography at baseline and at week 48. Quantitative interstitial lung disease (QILD) and fibrosis scores were assessed by computer software. We classified QILD into the following categories of lung involvement: mild (>5-10%), moderate (>10-20%), and severe (>20%). Results: Of 210 participants recruited for the trial, 136 patients (65%) had ILD. The majority of these patients (77%) had moderate-to-severe involvement (defined as >10% lung involvement). The TCZ arm demonstrated preservation of forced vital capacity percent predicted (FVC%) over 48 weeks (least squares mean change in FVC% = -0.1) compared to placebo (-6.3%). For mild, moderate, and severe QILD, the mean ± SD change in FVC% in the TCZ arm at 48 weeks were -4.1 ± 2.5% (n = 11), 0.7 ± 1.9% (n =19), and 2.1 ± 1.6% (n = 26), respectively, and in the placebo group were -10.0 ± 2.6% (n = 11), -5.7 ± 1.6% (n = 26), and -6.7 ± 2.0% (n = 16), respectively. Similar treatment-related preservation findings were seen independent of fibrosis severity. Conclusion: TCZ in early SSc-associated ILD with progressive skin disease stabilized FVC% over 48 weeks, independent of the extent of radiographically evident QILD.
MeSH term(s)	Adult ; Antibodies, Monoclonal, Humanized/therapeutic use ; Disease Progression ; Female ; Fibrosis ; Humans ; Image Processing, Computer-Assisted ; Lung/diagnostic imaging ; Lung/pathology ; Lung/physiopathology ; Lung Diseases, Interstitial/diagnostic imaging ; Lung Diseases, Interstitial/drug therapy ; Lung Diseases, Interstitial/physiopathology ; Male ; Middle Aged ; Scleroderma, Systemic/drug therapy ; Severity of Illness Index ; Spirometry ; Tomography, X-Ray Computed ; Treatment Outcome ; Vital Capacity
Chemical Substances	Antibodies, Monoclonal, Humanized ; tocilizumab (I031V2H011)
Language	English
Publishing date	2021-05-25
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.41668
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