Phase II Investigation of the Efficacy of Antimycobacterial Therapy in Chronic Pulmonary Sarcoidosis

Drake, Wonder; Culver, Daniel A.; Baughman, Robert P.; Judson, Marc A.; Crouser, Elliott D.; Ayers, Gregory D.; Ding, Tan; Abel, K.; Green, Abena; Kerrigan, Amy; Sesay, Ahmed; Bernard, Gordon R.

doi:10.1016/j.chest.2020.12.027

Cited by 32 publications

(23 citation statements)

References 34 publications

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“…While further work is needed to explore the long-term stability of remission in patients with previously recurrent sarcoidosis, sustained antigen tolerance is a plausible mechanism. In contrast to tolerance, findings from a Phase I preclinical sarcoidosis trial suggested that enhancing host immune responses may facilitate antigen clearance, lending hope for true long-term disease remission ( 27 ).…”

Section: Discussionmentioning

confidence: 99%

Stable Extent of Recurrently Active Cardiac and Cutaneous Sarcoidosis

et al. 2021

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Background: Recurrent or persistently active sarcoidosis is a risk factor for permanent organ damage. Whether this damage is due to accumulated focal injuries or progressive disease extent is not known, as the natural history of chronic inflammation in sarcoidosis is poorly characterized. The objective of this study is to determine the pattern of disease in recurrently active sarcoidosis.Methods: We identified patients with recurrent cardiac sarcoidosis (N = 21) retrospectively from an imaging database, and with recurrent cutaneous sarcoidosis (N = 17) from a prospective registry. The longitudinal patterns of cardiac sarcoidosis were established by findings on cardiac positron emission tomography scans, and of cutaneous sarcoidosis by the validated Cutaneous Sarcoidosis Activity and Morphology Instrument clinical scoring system. Patterns of recurrent disease were compared to baseline findings.Results: Recurrent sarcoidosis occurred in a nearly identical pattern and distribution as baseline disease, and spread of disease was rarely observed for both cardiac and cutaneous sarcoidosis: 97% of heart segments positive on recurrence scans were positive on baseline scans, and only one new region of facial disease was observed. In some cases, recurrence followed years of apparent remission.Discussion: Across phenotypes, and across a long period of follow-up, the extent of sarcoidosis was stable in spite of fluctuations in disease activity. For patients with a demonstrated history of recurrent disease affecting critical organs, our findings support the need for long-term follow-up.

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Section: Discussionmentioning

confidence: 99%

Stable Extent of Recurrently Active Cardiac and Cutaneous Sarcoidosis

et al. 2021

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“…As much as is possible, trial populations should be reflective of the populations affected by the disease of interest. Sarcoidosis occurs three times more commonly in African Americans and presents with disproportionate severity in patients of a lower socioeconomic status (SES) (40,42,45,103,104), yet most trial populations thus far have not been reflective of this racial prevalence of disease (105,106). Several studies show that African Americans are less likely to both qualify for and to participate in clinical trials due to several reasons such as mistrust in the system, lack of interest in clinical trials, fear and stigma associated with participation, and a perception that they may not be compliant with trial protocols (107)(108)(109)(110).…”

Section: Challenges Affecting Drug Trials and Drug Development In Sar...mentioning

confidence: 99%

Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches

et al. 2022

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Sarcoidosis is a systemic granulomatous inflammatory disease of unknown etiology. It affects the lungs in over 90% of patients yet extra-pulmonary and multi-organ involvement is common. Spontaneous remission of disease occurs commonly, nonetheless, over 50% of patients will require treatment and up to 30% of patients will develop a chronic progressive non-remitting disease with marked pulmonary fibrosis leading to significant morbidity and death. Guidelines outlining an immunosuppressive treatment approach to sarcoidosis were recently published, however, the strength of evidence behind many of the guideline recommended drugs is weak. None of the drugs currently used for the treatment of sarcoidosis have been rigorously studied and prescription of these drugs is often based on off-label” indications informed by experience with other diseases. Indeed, only two medications [prednisone and repository corticotropin (RCI) injection] currently used in the treatment of sarcoidosis are approved by the United States Food and Drug Administration. This situation results in significant reimbursement challenges especially for the more advanced (and often more effective) drugs that are favored for severe and refractory forms of disease causing an over-reliance on corticosteroids known to be associated with significant dose and duration dependent toxicities. This past decade has seen a renewed interest in developing new drugs and exploring novel therapeutic pathways for the treatment of sarcoidosis. Several of these trials are active randomized controlled trials (RCTs) designed to recruit relatively large numbers of patients with a goal to determine the safety, efficacy, and tolerability of these new molecules and therapeutic approaches. While it is an exciting time, it is also necessary to exercise caution. Resources including research dollars and most importantly, patient populations available for trials are limited and thus necessitate that several of the challenges facing drug trials and drug development in sarcoidosis are addressed. This will ensure that currently available resources are judiciously utilized. Our paper reviews the ongoing and anticipated drug trials in sarcoidosis and addresses the challenges facing these and future trials. We also review several recently completed trials and draw lessons that should be applied in future.

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“… 53 Antimycobacterial treatment (CLEAR regimen) for 4 months failed to demonstrate clinical or physiological improvement in chronic pulmonary sarcoidosis. 54 Repository corticotropin injection (RCI) was approved in the 1950s for sarcoidosis. Originally considered a steroid analog, RCI may have additional immunological properties and a steroid-sparing effect, although its action is currently limited.…”

Section: Treatmentsmentioning

confidence: 99%

State-of-the-Art Treatments for Sarcoidosis

Papanikolaou¹,

Antonakis²,

Pandi³

2022

Methodist DeBakey Cardiovascular Journal

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Sarcoidosis is a heterogeneous disease with various treatment indications. Although it affects mainly the lungs, sarcoidosis can affect every organ, especially when the disease course is chronic and protracted. Regular patient follow-up is recommended for early recognition of active, ongoing organ-specific granulomatous inflammation to avoid progression to irreversible fibrosis. In this review, we elaborate on treatment indications and various anti-sarcoidosis regimens proven useful in clinical trials. We also review specialized treatment of specific disease manifestations, with a focus on cardiac sarcoidosis. We also report on treatment for special conditions such as fatigue and small fiber neuropathy. Treatment for sarcoidosis is an emerging landscape, with new data complementing the existing knowledge.

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Phase II Investigation of the Efficacy of Antimycobacterial Therapy in Chronic Pulmonary Sarcoidosis

Cited by 32 publications

References 34 publications

Stable Extent of Recurrently Active Cardiac and Cutaneous Sarcoidosis

Stable Extent of Recurrently Active Cardiac and Cutaneous Sarcoidosis

Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches

State-of-the-Art Treatments for Sarcoidosis

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