Why are some monoclonal biologics premedicated with Solu-Medrol (methylprednisolone)?

From the Guidelines

Monoclonal biologics are premedicated with Solu-Medrol (methylprednisolone) to prevent or reduce infusion-related reactions, as supported by the most recent evidence from 2020 1. These reactions occur because monoclonal antibodies can trigger immune responses when administered intravenously, ranging from mild symptoms like fever, chills, and rash to severe reactions including hypotension, bronchospasm, and anaphylaxis. Solu-Medrol, a potent corticosteroid with strong anti-inflammatory and immunosuppressive properties, helps mitigate these reactions by suppressing the release of inflammatory mediators and inhibiting immune cell activation. Some key points to consider when premedicating with Solu-Medrol include:

• Typical premedication protocols include 50-100 mg of Solu-Medrol given intravenously 30-60 minutes before the biologic infusion, often combined with antihistamines like diphenhydramine (25-50 mg) and sometimes acetaminophen (650 mg) 1.
• This premedication approach is particularly important for biologics with higher rates of infusion reactions such as rituximab, infliximab, and certain checkpoint inhibitors.
• The need for premedication may decrease with subsequent infusions if patients tolerate initial treatments well, though this should be determined on an individual basis by the treating physician.
• The use of premedication is supported by guidelines, including those from the European Society for Medical Oncology (ESMO) 1 and the Journal of Allergy and Clinical Immunology 1. However, it's essential to weigh the benefits and risks of premedication, considering the uncertainty of evidence and potential variability in patient values and preferences 1. In clinical practice, the decision to premedicate with Solu-Medrol should be made on a case-by-case basis, taking into account the specific biologic agent, patient history, and potential risks and benefits.

From the FDA Drug Label

Corticosteroids, including methylprednisolone sodium succinate, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens

Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection

Some monoclonal biologics are premedicated with Solu-Medrol (methylprednisolone) to reduce the risk of immune-mediated reactions and infusion-related reactions. The use of corticosteroids like methylprednisolone can help suppress the immune system and reduce the likelihood of an adverse reaction to the biologic agent.

• Key benefits of premedicating with Solu-Medrol include:
  • Reduced risk of infusion-related reactions
  • Minimized immune-mediated responses
  • Improved tolerability of the biologic agent 2 2

From the Research

Premedication with Solu-Medrol for Monoclonal Biologic Infusions

• Solu-Medrol, a corticosteroid, is often used as a premedication to prevent infusion-related reactions in patients receiving monoclonal biologic therapies 3, 4.
• The use of corticosteroids, such as methylprednisolone, has been shown to decrease the severity of infusion-associated immediate adverse reactions in patients with humoral immunodeficiency disorders 4.
• Premedication with antihistamines, acetaminophen, and/or corticosteroids is a common practice to prevent infusion reactions with all monoclonal antibodies 3.
• However, the effectiveness of premedication with methylprednisolone in preventing infusion-related reactions to infliximab in pediatric patients has been questioned, with one study finding no statistically significant difference in allergic reactions between patients who received methylprednisolone as a premedication and those who did not 5.
• The use of premedication to prevent nonhemolytic transfusion reactions has also been evaluated, with a systematic review and meta-analysis finding no benefit with premedication using acetaminophen and antihistamines 6.

Mechanism of Infusion Reactions

• Infusion reactions can be allergic or nonallergic in nature, with clinical manifestations including anaphylactic and anaphylactoid reactions 7.
• The pathophysiology underlying infusion reactions is complex and involves the immune system, with cytokine release playing a role in nonallergic reactions 7.
• Understanding the underlying mechanisms of infusion reactions is essential for identifying patients at risk and providing optimal prophylactic measures and management of symptoms 3, 7.

Clinical Implications

• Clinicians should recognize the heterogeneity of infusion reactions and identify patients at risk to provide optimal prophylactic measures and management of symptoms 3.
• The use of premedication, including corticosteroids such as Solu-Medrol, should be tailored to the individual patient's risk factors and medical history 3, 4, 5.
• Further research is needed to evaluate the effectiveness of premedication in preventing infusion-related reactions and to identify the most effective premedication regimens for different patient populations 5, 6.