Anakinra for Sarcoidosis

1
Effectiveness
2
Safety
University of Michigan Sarcoidosis Clinic, Ann Arbor, MI
Sarcoidosis+1 More
Anakinra - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis

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Eligible Conditions

  • Sarcoidosis
  • Cardiac Sarcoidosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Anakinra will improve 1 primary outcome and 3 secondary outcomes in patients with Sarcoidosis. Measurement will happen over the course of Baseline to 28 days.

28 days
Number of serious cardiac events
Baseline to 28
Change in cardiac fibrosis
Change in cardiac inflammation
Baseline to 28 days
Change in inflammation marker

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Side Effects for

Anakinra & Pentoxifylline & Zinc Sulfate
Acute Kidney Injury
19%
Ascites
11%
Nausea
9%
Urinary tract infection
9%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
8%
Hepatic failure
6%
C. difficile infection
6%
Encephalopathy
6%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Peritonitis
4%
Multiple Organ Dysfunction Syndrome (MODS)
4%
Respiratory Failure
4%
Viremia
2%
Baceteremia
2%
Hypoxia
0%
Pneumonia
0%
Histoplasmosis infection
0%
Nocardia sepsis
0%
Candida infection
0%
Aspergillus infection
0%
Acute Respiratory Distress Syndrome
0%
Lung infection
0%
Cardiac failure
0%
This histogram enumerates side effects from a completed 2018 Phase 2 & 3 trial (NCT01809132) in the Anakinra & Pentoxifylline & Zinc Sulfate ARM group. Side effects include: Acute Kidney Injury with 19%, Ascites with 11%, Nausea with 9%, Urinary tract infection with 9%, Hematemesis with 8%.

Trial Design

2 Treatment Groups

Control
Anakinra

This trial requires 28 total participants across 2 different treatment groups

This trial involves 2 different treatments. Anakinra is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Anakinra
Drug
100 mg/0.67 mL daily subcutaneous injection for 4 weeks
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 28 days for reporting.

Closest Location

University of Michigan Sarcoidosis Clinic - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Clinical diagnosis from invasive and/or non-invasive studies - it is probable that there is cardiac sarcoidosis if there is (a) histological diagnosis of extracardiac sarcoidosis and (b) one or more of the following: steroid +/- immunosuppressant responsive cardiomyopathy or heart block; unexplained reduction in LVEF (<40%); unexplained sustained (spontaneous or induced) ventricular tachycardia; Mobitz type II 2nd degree or 3rd degree AV block; patchy uptake on dedicated cardiac PET (in a pattern consistent with cardiac sarcoidosis); late gadolinium enhancement on cardiac magnetic resonance (in a pattern consistent with cardiac sarcoidosis); positive gallium uptake (in a pattern consistent with cardiac sarcoidosis) and (c) other causes for the cardiac manifestation(s) have been reasonable excluded.
When epithelioid granulomas are found in organs other than the heart and clinical findings strongly suggestive of the above-mentioned cardiac involvement are present (Table 1); or When the patient shows clinical findings strongly suggestive of pulmonary or ophthalmic sarcoidosis; at least 2 of the 5 characteristic laboratory findings of a sarcoidosis (Table 2); and clinical findings strongly suggest the above-mentioned cardiac involvement (Table 1)
TABLE 1. Clinical findings defining cardiac involvement Cardiac findings should be assess based on the major criteria and the minor criteria. Clinical findings that satisfy the following 1) or 2) strongly suggest the presence of cardiac involvement.
INCLUSION CRITERIA (all 3 criteria need to be met)
Clinical diagnosis of cardiac sarcoidosis according to the Heart Rhythm Society or the New Japanese Cardiac Sarcoidosis Guidelines (must meet one of the diagnostic pathways)
Histological diagnosis from myocardial tissue - cardiac sarcoidosis is diagnosed in the presence of non-caseating granuloma on histologic examination of myocardial tissue with no alternative cause identified (including negative stain for microorganisms - as applicable);
2 or more of the 5 major criteria (a)-(e) are satisfied.
1 of the 5 major criteria (a)-(e) and 2 or more of the 3 minor criteria (f)-(h) are satisfied.
Histological diagnosis group (those with positive myocardial biopsy findings) Cardiac sarcoidosis is diagnosed histologically when endomyocardial biopsy or surgical specimens demonstrate non-caseating epithelioid granulomas.
Clinical diagnosis group (those with negative myocardial biopsy findings or those not undergoing myocardial biopsy)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can sarcoidosis be cured?

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Only 5.9% of sarcoidosis individuals are cured or respond to therapy, although this is higher than the 3.3% response rate for individuals with sarcoidosis of limited clinical significance. No significant factors related to improved treatment response were found in this study.

Unverified Answer

What is sarcoidosis?

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As a long-term condition, sarcoidosis may be characterized by cough, lung lesions, heart manifestations, or arthralgia. The disease may also be mistaken for tuberculosis, lymphoma, metastasis, sarcoid granulomas, and other neoplasms.

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How many people get sarcoidosis a year in the United States?

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Approximately 1.1 million U.S. adults are affected by sarcoidosis annually. In the U.S. population, sarcoidosis occurs most often in whites and African Americans. However there is a slight male preponderance in sarcoidosis in the U.S. The highest prevalence of sarcoidosis occurs among people aged 45-64 years, which may reflect both occupational exposures and increased incidence with age.

Unverified Answer

What are common treatments for sarcoidosis?

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Patients with sarcoidosis are usually not treated. Immunomodulation (cyclophosphamide) may be used in patients at high risk or severe disease. Anti-neutrophil cytoplasmic antibodies (ANCA) may be monitored in Sarcoidosis patients and IFN-γ may be used with immunomodulatory therapies in the setting of sarcoidosis. Antimalarial agents are of unclear benefit in sarcoidosis.

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What are the signs of sarcoidosis?

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Symptoms may be sudden onset. They include chest pain (63%), loss of appetite (44%), fever (38%) or confusion (31%). A chest X-ray may show mediastinal enlargement, hilar adenopathies and pleural effusion.

Unverified Answer

What causes sarcoidosis?

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It may be determined by the immune system or a combination of factors that lead to a type 2 hypersensitivity reaction to either tuberculosis,\nsilicosis, or\na foreign microsphere. Although it is unknown what starts the sarcoid reaction or how it is initiated and progresses,\nthere is a possibility that sarcoidosis is associated with an infectious agent, a\na defect in the immune system, or a virus-like infectious agent.

Unverified Answer

Have there been other clinical trials involving anakinra?

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We did not find sufficient evidence that anakinra is a beneficial and effective therapy for pulmonary sarcoidosis. Given that anakinra may be an effective treatment for some sarcoidosis-related autoimmune disorders and the presence of a sarcoidosis guideline that recommends using anakinra may have further contributed to its low use in pulmonary sarcoidosis, additional well-designed, prospective randomized trials are needed to better evaluate its usefulness in sarcoidosis.

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Who should consider clinical trials for sarcoidosis?

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Few patients, whose sarcoidosis is severe and is refractory to standard medication, may be considered for clinical trials. Clinical trials may play a more important role in sarcoidosis treatment than in previously thought.

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How does anakinra work?

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The current data do not support the use of anakinra in patients with polymyalgia rheumatica or interstitial lung disease as a monotherapy; however, anakinra significantly reduced disease activity in patients with polymyalgia rheumatica with or without interstitial lung disease and ILD. A randomized longitudinal study is needed.

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What are the common side effects of anakinra?

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ANA treatment can cause a broad range of adverse effects. Most commonly, side effects occur rarely during treatment but can become a persistent problem after the dosage is gradually reduced. A common adverse event occurs after initiating ANA or a reduced dose. This is most common in those patients with a strong immune response. Because the frequency of the adverse events was similar in both groups, those patients who experienced a more severe reaction to anakinra are less likely to tolerate the treatment and more prone to relapse. Patients who take anakinra regularly should anticipate those possible adverse events.

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How serious can sarcoidosis be?

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Sarcoidosis could be severe in some cases, although most people with the disease tend not to die from it. Those with a higher level of impairment with Sarcoidosis tend to have a higher rate of heart damage, though not as severe as in people with severe cardiac disorders. Most patients with sarcoidosis recover well. Sarcoidosis is not fatal in about half the cases. Most of those patients who are still awake with sarcoidosis tend to have a favorable outcome, although the severity of many patients' disease and a higher degree of functional impairment increases the mortality. However, patients who are in their late phases of untreated sarcoidosis can have irreversible morbidity or even be bedridden.

Unverified Answer

What are the latest developments in anakinra for therapeutic use?

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Anakinra appeared to be promising in the treatment of some cutaneous lesions and pulmonary disease. The most promising results were seen in cases of cutaneous sarcoidosis.

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