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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.