Have there been any human studies of immune therapy (IMTX) treatments?

From the Guidelines

Yes, there have been human studies of immune therapy (IMTX) treatments, with a notable example being rituximab, which has been studied in patients with mixed cryoglobulinemia syndrome (MCS) and has shown promising results in improving clinical manifestations and reducing cryoglobulin levels 1.

Key Findings

• Rituximab, a monoclonal antibody against the CD20 antigen, has been shown to be effective in treating MCS, with improvements in fatigue, skin manifestations, arthralgias, and glomerulonephritis 1.
• The medication has also been found to be effective in reducing cryoglobulin levels and improving renal response rates, with some studies suggesting a synergistic effect when combined with antiviral therapy 1.
• However, rituximab can increase the risk of infections, particularly in patients with low serum immunoglobulin levels or those who have previously been treated with immunosuppressants or steroids 1.

Immune-Related Adverse Events

• Immune-related adverse events (irAEs) are a significant concern with immune therapy treatments, with a reported incidence of up to 90% in some studies 1.
• irAEs can affect almost any organ system and can be severe, with some cases resulting in treatment-related deaths 1.
• The exact pathogenesis of immune toxicity is not clear, but it is thought to involve the activation of immune cells, such as CD8 T cells, and the release of inflammatory cytokines 1.

Clinical Implications

• Human studies are essential for immune therapy treatments, as they require careful balance between preventing rejection or controlling autoimmunity and minimizing risks of infection, malignancy, and other side effects.
• Clinicians must be vigilant in monitoring patients for irAEs and instituting urgent and appropriate treatment when necessary.
• Further research is needed to fully understand the mechanisms of immune toxicity and to develop effective strategies for preventing and managing irAEs.

From the FDA Drug Label

14 CLINICAL STUDIES The FDA drug label does mention clinical studies for interferon beta-1a (IM), which is a type of immune therapy (IMTX) treatment.

• The label does not provide detailed information about these studies, but it implies that human studies have been conducted.
• Based on this information, it can be inferred that there have been human studies of immune therapy (IMTX) treatments, specifically for interferon beta-1a (IM) 2.

From the Research

Human Studies of Immune Therapy (IMTX) Treatments

• There have been several human studies on immune therapy treatments, specifically on interferon-beta-1a and interferon-beta-1b, which are used to treat multiple sclerosis (MS) 3, 4.
• These studies have shown that interferon-beta-1a and interferon-beta-1b can reduce the frequency and severity of relapses, slow disease progression, and improve quality of life for patients with MS 3, 4.
• The optimal route of administration for interferon-beta-1a is intramuscular injection, while interferon-beta-1b is administered subcutaneously 3, 4.
• Studies have also investigated the use of type 1 interferon-beta in promoting the growth and function of regulatory invariant natural killer T cells through dendritic cell maturation, which may contribute to its therapeutic effects in MS 5.

Administration of Immune Therapy Treatments

• Several studies have focused on the administration of intramuscular injections, including the development of best practice guidelines for nurses 6, 7.
• These guidelines aim to ensure the safe and effective administration of medications via the intramuscular route, which is a common method of delivery for immune therapy treatments 6, 7.
• The use of appropriate needle size, length, and injection site are crucial factors in the administration of intramuscular injections, and nurses should be aware of the latest evidence-based guidelines to inform their practice 6, 7.