A retrospective pilot study examining the use of Acthar gel in sarcoidosis patients

Baughman, Robert P.; Barney, Joseph B.; O'Hare, Lanier; Lower, Elyse E.

doi:10.1016/j.rmed.2015.11.007

Cited by 58 publications

(48 citation statements)

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“…2). It has been previously noted that RCI was associated with reduction of prednisone in most patients who remained on drug for more than 3 months [8]. We were unable to demonstrate that the reduction in prednisone dosage during the short course of this study was associated with lessening of the toxicities associated with high-dose prednisone such as weight gain and diabetes.…”

Section: Discussioncontrasting

confidence: 59%

“…Studies in infantile spasticity, renal disease, and multiple sclerosis have suggested that the stimulation of these melanocortin receptors may be an important mechanism of action [19–22]. Recent experience with using RCI for advanced sarcoidosis has suggested benefit for some patients with sarcoidosis [8, 23]. …”

Section: Discussionmentioning

confidence: 99%

“…A recent report demonstrated steroid sparing and, in some cases, improvement in patients with advanced sarcoidosis [8]. However, the dose of RCI and need for a loading dose in patients receiving chronic corticosteroids were unclear.…”

Section: Introductionmentioning

confidence: 99%

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Repository corticotropin for Chronic Pulmonary Sarcoidosis

Baughman

Sweiss

Keijsers

et al. 2017

Lung

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PurposeThe dose of repository corticotropin (RCI) and need for a loading dose in sarcoidosis patients receiving chronic corticosteroids are unclear. We performed a single-blind prospective study, comparing two doses of RCI in sarcoidosis.MethodsChronic pulmonary sarcoidosis patients receiving prednisone therapy with deterioration by 5% in FVC in the previous year were studied. RCI was administered subcutaneously at a loading dose of 80 units RCI for 10 days. Patients were randomized at day 14 to receive either 40- or 80-unit RCI twice a week. The dose of prednisone was modified by the clinician who was blinded to the patient’s dosage of RCI.ResultsSixteen patients completed the full 24 weeks of the study. At week 24, there was a decrease in the dose of prednisone, and improvements in DLCO, King’s Sarcoidosis Questionnaire health status and fatigue score. There was no significant change in FVC % predicted. For the PET scan, there was a significant fall in the standard uptake value (SUV) of the lung lesions. Only 3/8 patients remained on 80 units RCI for full 24 weeks. There was no significant difference in the response to therapy for those treated with 40- versus 80-unit RCI.ConclusionsRepository corticotropin treatment was prednisone-sparing and associated with significant improvement in DLCO, PET scan, and patient-reported outcome measures. A dose of 40-unit RCI twice a week was as effective as 80-unit RCI and was better tolerated.

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Section: Discussioncontrasting

confidence: 59%

Section: Discussionmentioning

confidence: 99%

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Repository corticotropin for Chronic Pulmonary Sarcoidosis

Baughman

Sweiss

Keijsers

et al. 2017

Lung

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“…In a retrospective series in pulmonary sarcoidosis, ACTHAR gel effected improvements in 11/29 (38%) patients, and allowed >50% prednisone dose reduction in an additional 16 (55%) patients. However, nearly 40% of treated patients were unable to continue the medication, mostly due to side effects [20]. Although ACTHAR gel, a mixture of pituitary extracts including mainly ACTH, activates endogenous cortisol production, it is likely that its effects may also involve nonglucocorticoid receptor mediated pathways.…”

Section: Acthar Gelmentioning

confidence: 99%

Sarcoidosis: treatments beyond prednisone and methotrexate

Neto

Culver

2017

Expert Review of Respiratory Medicine

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“…There have been few contemporary reports of the use of RCI for sarcoidosis [16,17], and only minimal information is available on the dosage and toxicity of RCI in treating patients with chronic sarcoidosis. The product labelling includes little guidance on dosing or the management of common and important adverse effects, leaving physicians who manage sarcoidosis with relatively little direction on the practical use of RCI.…”

Section: Introductionmentioning

confidence: 99%

Management of repository corticotrophin injection therapy for pulmonary sarcoidosis: a Delphi study

et al. 2020

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In patients treated with repository corticotrophin injection (RCI) for pulmonary sarcoidosis, effective management of adverse events may improve adherence. However, management of adverse events may be challenging due to limitations in real-world clinical experience with RCI and available published guidelines.We surveyed 12 physicians with a modified Delphi process using three questionnaires. Questionnaire 1 consisted of open-ended questions. Panellists' answers were developed into a series of statements for Questionnaires 2 and 3. In these, physicians rated their agreement with the statements using a Likert scale.Key consensus recommendations included a starting dose of 40 units twice a week for patients with less severe disease, continued at a maintenance dose for patients who responded, particularly those with chronic refractory sarcoidosis. Panellists reached consensus that concomitant steroids should be quickly tapered in patients receiving RCI, but that concomitant use of immunosuppressive medications should be continued. Panellists developed consensus recommendations for adverse event management, and reached consensus that RCI should be down-titrated or discontinued if other interventions for the adverse effects fail or if the adverse effect is severe.In the absence of clinical evidence, our Delphi consensus opinions may provide practical guidance to physicians on the management of RCI to treat pulmonary sarcoidosis.

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A retrospective pilot study examining the use of Acthar gel in sarcoidosis patients

Abstract: In this group of advanced sarcoidosis patients, Acthar gel treatment for at least three months was associated with objective improvement in a third of patients. A third of patients were unable to take at least a three months of treatment.

Cited by 58 publications

References 30 publications

Repository corticotropin for Chronic Pulmonary Sarcoidosis

Repository corticotropin for Chronic Pulmonary Sarcoidosis

Sarcoidosis: treatments beyond prednisone and methotrexate

Management of repository corticotrophin injection therapy for pulmonary sarcoidosis: a Delphi study

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