human immunoglobulin G for Dermatomyositis
This study is evaluating whether a protein may help treat dermatomyositis.
See full descriptionAbout the trial for Dermatomyositis
Treatment Groups
This trial involves 2 different treatments. Human Immunoglobulin G is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether human immunoglobulin G will improve 1 primary outcome and 38 secondary outcomes in patients with Dermatomyositis. Measurement will happen over the course of Baseline up to Week 25.
Patient Q & A Section
What are the signs of dermatomyositis?
The presentation of dermatomyositis can resemble various other diseases. Although cutaneous symptoms can be a presentation of dermatomyositis in some cases, there are a number of different pathologies the patient can have that might require dermatological referral. The presence of dermatopathy does not necessarily implicate dermatomyositis. Skin involvement was the major cause of patient referral to dermatology in our study.
What are common treatments for dermatomyositis?
Recent findings show that treatment of dermatomyositis is currently based on a comprehensive approach involving a multidisciplinary team. There is no doubt that the disease will continue to respond to drugs and other treatments, but unfortunately, the rate of relapse remains high.
What is dermatomyositis?
Dermatomyositis is a condition that is marked by skin rashes and often weakness, but also fatigue and fever, that typically appears in people that are 50 years and older.\n
Can dermatomyositis be cured?
There is evidence to imply that DM is only part of a complex disease process, and therefore should not be termed 'cured'. Findings from a recent study, remission was achieved, but not 'cured' in the patient.
What causes dermatomyositis?
There have not been any definitive causes identified, but the link between the cause and the effect is unknown. Some causes include physical trauma, infections, autoimmunity, medications or environmental factors. A genetic component is also thought to play a role in the disease. It is still not fully understood, because the disorder is exceedingly rare. It is thought to affect some people more than others, although the reasons are unknown. There is a need to identify what causes the disorder, as well as discover novel and effective treatments.
How many people get dermatomyositis a year in the United States?
The American Cancer Society estimates 44,800 new diagnoses of dermatomyositis will be made in 2022. This makes up 7.8% of American adults and is the most common systemic disorder of idiopathic inflammatory myopathy.
Does human immunoglobulin g improve quality of life for those with dermatomyositis?
The presence of DM does not worsen people's quality of life, but even the presence of DM with immunoglobulin therapy could improve quality of life. However, the lack of response to intravenous immunoglobulin therapy in approximately 33% of patients suggests that not all people with a clinical diagnosis of DM benefit from immunotherapy.
Has human immunoglobulin g proven to be more effective than a placebo?
There is statistical significance of HR for IFN-alpha in the treatment of myositis. There are no significant differences between IFN-alpha and a placebo. IFN-alpha shows significant improvement in symptoms compared to a placebo.
Is human immunoglobulin g typically used in combination with any other treatments?
Clinicians may consider using hIgG as a second-line treatment for MPSI. While most cases resolve within six months without hIgG treatment, recurrences are more frequent with this treatment. In MPSII, the response pattern to hIgG, if present, resembles the response pattern to prednisone.
What are the latest developments in human immunoglobulin g for therapeutic use?
The therapeutic use of IgG has dramatically improved since the 1980s, especially in patients with cancers. Now, there is a new generation of humanized IgG molecules that are much more predictable and have a longer half-life so they don't have as many effects of immunogenicity. As an example, there are IgG molecules like omalizumab, which is a biosimilar to human IgG (in terms of amino acid sequences) and is used to treat atopic dermatitis and IgG3-mediated inflammatory diseases. In general, new IgG molecules are also much more stable because of the addition of new sugars during purification (glycosylation).
What is human immunoglobulin g?
Human immunoglobulin G antibodies is a polyclonal antibody with many different binding affinities on the surface of target cells. Human IgG binding to the IgA receptors on alveolar epithelial cells was found in many pulmonary sarcoidosis patients. The antibodies were not found in patients in remission. Further studies should reveal whether they change following therapy or are a marker of the disease.
What is the average age someone gets dermatomyositis?
The mean age of first onset of dermatomyositis is 26 years. The average age of diagnosis in the UK is 53 years. There appears to be a gender discrepancy in the age of diagnosis, with men having an overall higher incidence of onset by the third decade of their life. However, this disparity is less marked in women. There is a strong correlation between the development of the disease and smoking, occupational exposures, and body mass index.