Effects of Pidotimod on recurrent respiratory infections in children with Down syndrome: a retrospective Italian study

Abstract

Background: Children with Down syndrome (DS) show a high susceptibility to recurrent infections (RI), caused by immune defects and abnormalities of the airways. Our goal was to investigate the effects of Pidotimod on RI prevention in children with DS, comparing immune and clinical parameters before (T0) and after (T1) the treatment with Pidotimod. Methods: The study was conducted at the Down syndrome outpatient Center of Bambino Gesù Children's Hospital, in Rome. We reviewed the medical records of all children with a positive history for RI and who received oral prophylaxis of Pidotimod from September 2016 to February 2017. Results: Thirty-three children met the inclusion criteria (males: 51.5%; average age: 6 years ±SD: 3). We found a significant decrease in the number of children with upper respiratory infections (82% at T0 vs 24% at T1; p = 0,0001) and with lower respiratory infections (36% at T0 vs 9% at T1; p = 0.003) after treatment with Pidotimod. We also demonstrated a significant decrease in the number of children hospitalized for respiratory infections (18% at T0 vs 3% at T1; p = 0.03). We measured T and B cells in the peripheral blood and B cell function in vitro at T0 and T1. We found that the response to CpG improved at T1. A significant increase of B cell frequency (p = 0.0009), B cell proliferation (p = 0.0278) and IgM secretion (p = 0.0478) were observed in children with DS after treatment. Conclusions:Our results provided evidence that Pidotimod may be able to prevent RI in children with Down syndrome.

Proposal for a new therapeutic high dosage of Pidotimod in children with Periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) syndrome: an observational study.

“…Among the molecules capable of interfering in the innate and adaptive immune response, Pidotimod, an immunomodulatory agent able in increasing antigen presentation and promoting adaptive Th1-mediated immunity, showed good efficacy and safety when administered in, addition to a bacterial lysate, in children aged 3-12 years with PFAPA [11]. In their study, authors administered Pidotimod 200 mg/daily for 20 days for a minimum of 6 consecutive months and up to 36 months with a summer break of 4 to 6 months [10]; and reported that the healing rate of PFAPA symptoms was 68% (n = 25 patients), with 11% (n = 4 cases) in complete remission at the end of the second year of follow-up. Overall, 78% children (n = 29) experienced a marked decrease in the incidence of fever, a reduced antipyretic drugs and antibiotics use, a markedly improved quality of life as assessed by a decreased time lost from school for the children and work for the parents.…”

“…In light of evidence that an abnormal host immune response is featuring patients with PFAPA syndrome, immunostimulant drugs have been hypothesized to be new and potential molecules able to attenuate the inflammatory status in PFAPA syndrome, thus, preventing disease attacks. In this regard, Pidotimod, (PDT, 3-L-pyroglutamyl-L-thiaziolidine-4-carboxylic acid), a synthetic dipeptide molecule, showed significant immunomodulatory effects, especially in children suffering from respiratory tract infections [9,10]. By acting both on innate and adaptive immune response, Pidotimod administration has been significantly associated with a reduction of the number of infections, number of days of fever, a less severity of signs and symptoms, and, consequently, a reduction in use of antibiotics and symptomatic drugs [9].…”

COVID‐19 and Down syndrome

“…As COVID‐19 presents as an acute severe respiratory syndrome and DS is by far the most frequent chromosomal disease with the highest susceptibility to develop respiratory infections and complications, 1 it seems timely to focus on this syndrome during the ongoing pandemic.…”

Proposal for a new therapeutic high dosage of Pidotimod in children with Periodic fever, aphthous stomatitis, pharyngitis, adenitis (PFAPA) syndrome: a randomized controlled study.

“…In light of evidence that an abnormal host immune response is featuring patients with PFAPA syndrome, immunostimulant drugs have been hypothesized to be new and potential molecules able to attenuate the in ammatory status in PFAPA syndrome, thus, preventing disease attacks. In this regard, Pidotimod, (PDT, 3-L-pyroglutamyl-Lthiaziolidine-4-carboxylic acid), a synthetic dipeptide molecule, showed signi cant immunomodulatory effects, especially in children suffering from respiratory tract infections [11,12]. By acting both on innate and adaptive immune response, Pidotimod administration has been signi cantly associated with a reduction of the number of infections, number of days of fever, a less severity of signs and symptoms, and, consequently, a reduction in use of antibiotics and symptomatic drugs [11, gure 1].…”