This article, about an
early trial for a new MS drug that is delivered via skin patch sounds
promising. It is early phase I meaning it will be at least 5-6
years before we see it approved by the FDA if it works well and is found to be
safe.
early trial for a new MS drug that is delivered via skin patch sounds
promising. It is early phase I meaning it will be at least 5-6
years before we see it approved by the FDA if it works well and is found to be
safe.
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Published: Jul 1, 2013 | Updated: Jul 2, 2013
By John Gever, Deputy Managing Editor, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner
..
A skin patch delivering peptides derived from the presumed autoimmune target in multiple sclerosis reduced relapse frequency and brain lesions in a pilot clinical trial, researchers said.
In 30 patients with relapsing-remitting MS enrolled in the 1-year, placebo-controlled trial, those receiving the myelin skin patches containing 1 mg of peptides had an annualized relapse rate of 0.43 versus 1.4 in patients treated with a placebo patch (P=0.007), according to Krzysztof Selmaj, MD, PhD, of the Medical University of Lodz in Poland, and colleagues.
The mean cumulative number of gadolinium-enhancing brain lesions per patient was lower with the 1 mg patch by 66.5% compared with controls (0.0085 versus 0.0255, P=0.02), they reported online in JAMA Neurology.
However, a 10-mg patch appeared to be substantially less effective than the lower-dose patch. Brain lesion counts and volumes in this group (which had only four patients) were similar to those in the placebo group, even as the mean annualized relapse rate was lower at 0.25 than in either of the other two treatment arms (P not reported).
Selmaj and colleagues speculated that the higher peptide dose in the 10-mg patch may have triggered increased pathological immune cell activity, potentially “induc[ing] a number of specific T cells to differentiate into effector cells,” they wrote.
No serious adverse events were reported. Patch-site reactions of “modest intensity” were seen in four of the 20 patients receiving the myelin patches. Other adverse effects occurred at similar rates in all three arms.
In an accompanying commentary, Lawrence Steinman, MD, of Stanford University, called the results “promising” and added that they were consistent with what many in the field have considered the Holy Grail in MS: the induction of immunological tolerance.
MS is widely believed to result from an autoimmune attack on myelin, the principal component of the sheathing that surrounds nerve fibers. When the myelin sheaths become sufficiently degraded, nerve function is impaired as well.
But, compared with the drug-development effort industry has expended toward agents that interfere with some aspect of immune function, comparatively little has focused on persuading the immune system to stop attacking myelin in the first place, Steinman indicated.
“It is clear that the pharmaceutical industry is taking the safer approach, the ‘well-traveled road,’ when they redirect drugs with a major impact on immune function, drugs often already approved for other diseases,” he wrote, alluding to drugs such as anti-CD20 drugs including rituximab (Rituxan) and ocrelizumab and the anti-CD52 agent alemtuzumab (Lemtrada).
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