Successful subcutaneous Immunoglobulin Therapy in patients with ME/CFS

 

Swedish researchers have found promising effects on symptoms in 17 people with infection associated ME/CFS from subcutaneous treatment (under the skin) with low-dose Immunoglobulin (IG) – Hizentra. Immunoglobulins are antibodies found in white blood cells that fight infection. Low levels suggest your immune system is not functioning well.

Patients were predominantly female (65%) with mild-to-moderate disease severity (82%) and with poor self-reported quality of life and working ability before treatment.

This is thought to be the first study of subcutaneous IG as previously studies tested intravenous or intramuscular IG treatment, which results in much higher drug doses.

The findings from this case series (i.e. not a Randomized control trial – RCT) merit further investigation through well-controlled trials on subcutaneous IG treatment of patients with ME/CFS selected for being potential responders to the treatment.

Successful subcutaneous Immunoglobulin Therapy in a case series of patients with ME/CFS by Per Sjogren, Bjorn Bragée, Sven Britton in Clinical Therapeutics June 22, 2024 [doi.org/10.1016/j.clinthera.2024.05.010]

Research abstract:

Purpose
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) remains an enigma with no curable treatment options at hand. Although patients with ME/CFS are a heterogeneous group, a large proportion of patients present with an infection-driven symptomatology, making them potential responders to immunologic treatments, such as immunoglobulin (IG). Previous studies on IG treatment in patients with ME/CFS have not been consistent but have described beneficial effects in subgroups of patients.

Methods
Here we present data on a series of cases (n = 17) with infection-related ME/CFS (as defined by disease history and ongoing recurrent infections) treated with subcutaneous low-dose IG (0.06 g/kg/mo) over 5 weeks with continuous monitoring of symptoms.

Findings
Patients were predominantly female (65%) with mild-to-moderate disease severity (82%) and with poor self-reported quality of life (median, 25 on a 0–100 scale) and working ability (median, 5 on a 0–100 scale) before treatment. After 5 weeks of treatment with low-dose IG, significant improvements in symptoms, quality of life, and working ability were noted (all P < 0.05). Among the 7 patients who reported the highest benefit of the treatment, quality of life increased by 35 units (on a 0–100 scale), with 1 patient reporting complete elimination of ME/CFS symptoms. No serious side effects were detected with the treatment.

Implications
In this limited-sized case series, we found pronounced beneficial effects of low-dose IG in a large proportion of patients with infection-related ME/CFS. Further well-controlled studies are needed to verify the potential benefits of IG treatment in patients with ME/CFS with infection-driven symptomatology.

NB

Back in 2021 our medical adviser Dr Nigel Speight and colleague Helen Brownlie wroe a paper suggesting a role for IG Therapy in ME/CFS.

Back to the Future? Immunoglobulin therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, by  Helen Brownlie and Nigel Speight in Healthcare 2021, 9(11), 1546; [doi.org/10.3390/healthcare9111546]   12 Nov 2021 (This article belongs to the Special Issue ME/CFS – the Severely and Very Severely Affected)

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