No clinical pain relief from intravenous immunoglobulin (IVIg) therapy was observed in patients with painful idiopathic small fiber neuropathy (I-SFN), according to study results published in Neurology.
Study researchers conducted a randomized, placebo-controlled, double-blind clinical trial (ClinicalTrials.gov Identifier: NCT02637700) to evaluate the efficacy and safety of IVIg in patients with I-SFN. They recruited patients (N = 60) with I-SFN at Maastricht University Medical Center in the Netherlands between 2016 and 2019. Stratified by age and gender, patients were randomly assigned 100 mg / ml Gamunex® 10% with a 2 g / kg upload dose (n = 30) or placebo (n = 30) for 12 weeks. The patients were examined after 3 and 6 months for changes in pain symptoms, as measured by the numerical 11-point rating scale for pain intensity.
Patients in the treatment and placebo groups had a mean age of 48.7 years (standard deviation) [SD], 11.1) and 50.7 (SD, 9.7) years, 33.3% and 40.0% were men, 93.3% and 96.7% were white, and for SFN a median of 7 , 8 (range 1.3-58.5) and 7.4 (range 1.7-) were diagnosed. 34.9) years earlier.
Among all participants, the mean baseline pain was 5.8 (range 1.7-9.5), maximum pain was 7.0 (range 2.2-10.0), and the mean daily sleep interference scale (DSIS) was 5.5 (Range 0.0-9.0).
In the protocol analysis, IVIg therapy was not significantly associated with at least 1 point (odds ratio) [OR]1.89; 95% CI, 0.61-6.04; P = 0.415) or at least 2 points (OR 1.73; 95% CI 0.47-6.79; P = 0.624) decrease in mean pain.
After 3 months, IVIg treatment resulted in a change in the DSIS score (-1.57 versus -0.18; P = 0.045), the intensive score of the Neuropathic Pain Scale (NPS) (-2.33 versus -0.77 ; P = 0.011) and the NPS hot connected score (-1.75 vs 0.15; P = 0.021), unpleasant NPS score (-2.08 vs -0.62; P = 0.022), short form 36 ( SF-36) Physical Function Score (12.3 vs 2.11; P = 0.027)), SF-36 Vitality Score (8.59 vs. -0.24; P = 0.036), and SF-36 Health Change Score ( 34.38 versus 12.50; P = 0.016) versus placebo. After 6 months, only the DSIS values remained significantly different between the groups (-1.64 versus 0.51; P = 0.006).
Serious adverse events each included a single headache, hospitalization, pulmonary embolism, and suicide attempt in the treatment group, and aortic coarctation repair in the placebo cohort. All serious events in the treatment group, with the exception of hospitalization (with multiple complaints), occurred during the follow-up phase.
For frequent adverse events, IVIg recipients reported increased headache (100% versus 56.7%; P <0.001), nausea (63.3% versus 23.3%; P = 0.004), and vomiting (36.7% versus 0 , 0%; P = 0.001). and rash (26.7% vs 0.0%; P = 0.005) as placebo recipients.
This study was limited by its performance due to its small sample size, where researchers could only determine a response rate of 25% or more.
These data indicated that IVIg therapy was ineffective in relieving pain in patients with I-SFN.
Disclosure: Some of the study’s authors stated links with biotech, pharmaceutical, and / or device companies. See the original reference for a full list of specifications
Geerts M. de Greef BTA, Sopacua M. et al. Intravenous immunoglobulin therapy in patients with painful idiopathic small fiber neuropathy. Neurology. Published online March 25, 2021. doi: 10.1212 / WNL.0000000000011919