A blood-cleansing process known as immunoadsorption appears to be superior to plasma exchange in treating relapses that don’t respond to conventional steroid therapy in people with multiple sclerosis (MS) or clinically isolated syndrome (CIS), a study reports.
These findings were reported in “Safety and efficacy of immunoadsorption versus plasma exchange in steroid-refractory relapse of multiple sclerosis and clinically isolated syndrome: A randomised, parallel-group, controlled trial,” published in the journal EClinicalMedicine.
More than 80% of patients with MS follow a relapsing-remitting disease course. Relapses tend to improve after intravenous high-dose methylprednisolone (MP) steroid therapy. But not all RRMS patients respond to steroid therapy.
Plasma exchange is considered a standard approach for relapses resistant to steroid treatment in people with MS or CIS (a first episode of neurologic symptoms that lasts at least 24 hours).
In plasma exchange, the patient’s plasma (a component of the blood) is removed and replaced by a substitute. The method is often used to treat autoimmune diseases, as it helps remove pro-inflammatory components from the blood.
Immunoadsorption is an alternative method that selectively removes immunoglobulins (antibodies), while preserving other plasma proteins. Although immunoadsorption has been shown to be well-tolerated and a low-risk procedure, evidence for its effectiveness is lacking.
Researchers at the University of Ulm, in Germany, conducted a controlled trial (NCT02671682) to investigate whether immunoadsorption is superior to plasma exchange in 61 MS and CIS patients with acute relapses, and an insufficient response to high-dose intravenous MP after at least one cycle. The median age of the immunoadsorption group was 40.1 years and 37.5 years for those given plasma exchange; patients in both groups had median Expanded Disability Status Scale (EDSS) scores of 3.0, indicating moderate functional disability.
Participants were randomly assigned to either immunoadsorption (31 patients) or plasma exchange (30 patients), both given in a total of five treatments on five consecutive days. They were examined immediately after the last treatment, and again two and four weeks later.
The study’s primary goal was changes four weeks post-treatment in their Multiple Sclerosis Functional Composite (MSFC) scores, which measures the degree of impairment, compared to scores recorded at the study’s start (baseline).
Results showed a median improvement in MSFC at one month post-treatment of 0.385 in the immunoadsorption (IA) group and 0.265 in the plasma exchange (PE) group, a significant difference.
Response rates to treatment at one month were 86.7% in the immunoadsorption group, and 76.7% in the plasma exchange group.
Both treatments were “generally well-tolerated,” the researchers wrote. One serious adverse event, deep vein thrombosis (a blood clot in a deep vein, usually in the legs) that was successfully treated without complications, occurred in each group.
Secondary efficacy goals also showed better sustained and larger long-term improvements in the immunoadsorption group.
Patients treated with immunoadsorption, but not plasma exchange, showed a significant improvement in their Symbol Digit Modalities Test (SDMT) scores, a neuropsychological test of cognitive abilities that mainly relies on attention and concentration, as well as on the Paced Auditory Serial Addition Test (PASAT), another measure of cognitive skills that is part of MSFC.
Overall, trial data found both immunoadsorption and plasma exchange were safe to use in patients with steroid-refractory relapses, and resulted in significant improvements in the MSFC one month post-treatment compared to the study’s start.
“Analysis of the primary endpoint (change of MSFC after 4 weeks compared to baseline) revealed that both treatments induced a significant improvement of symptoms without any major complications, strongly suggesting that apheresis should be applied when impairing symptoms persist after intravenous high-dose MP therapy,” the researchers wrote.
But, they continued: “Improvement of MSFC after 4 weeks … was significantly larger in IA patients compared to PE. Furthermore, the IA group showed a higher response rate after 4 weeks (86.7% vs. 76.7%), no secondary worsening of symptoms … and generally larger improvements of secondary efficacy endpoints.”
These results “indicate a potential superiority of IA compared to PE in treatment of steroid-refractory relapse in multiple sclerosis and clinically isolated syndrome, which has to be confirmed by future studies,” they concluded.