Impact of Innovative Treatment Using Biological Drugs for the Modulation of Diffuse Cutaneous Systemic Sclerosis: A Systematic Review.

Scleroderma or systemic sclerosis (SSc) is an autoimmune disease affecting the connective tissue, characterized by fibrosis of the skin and internal organs. There is currently no curative treatment available, so therapeutic action is aimed at a symptomatic treatment of the affected organs. The development of biotechnology has made it possible to implement certain biological drugs that could represent a window of opportunity to modulate the evolution and symptomatology of scleroderma with greater efficacy and less toxicity than conventional treatments. This study aimed to review the current evidence critically and systematically on the effects of biological drugs on the pulmonary function, skin disease, and health status of patients afflicted by diffuse cutaneous systemic sclerosis (dcSSc). Three electronic databases (Pubmed, Dialnet, and Cochrane Library Plus) were systematically searched until the cut-off date of October 2022. The review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and included original articles in English and Spanish with a controlled trial design, comparing biological drug treatments (tocilizumab, belimumab, riociguat, abatacept, and romilkimab) with a control group. The methodological quality of the studies was assessed using the McMaster quantitative form and the PEDro scale. A total of 383 studies were identified, 6 of them met the established criteria and were included in the present systematic review. A total of 426 patients treated with tocilizumab, belimumab, riociguat, abatacept, and romilkimab were included. The results showed substantial non-significant (p < 0.05) improvement trends after treatment with the biological drugs included in this review for the modified Rodnan Scale Value, Forced Vital Capacity, and Carbon Monoxide Diffusion Test; however, no benefits were shown on the Health Assessment Questionnaire-Disability Index when compared to the control group. Biological drugs, therefore, maybe a new therapeutic strategy for dcSSc and could be recommended as an additional and/or adjunctive treatment that promotes anti-fibrotic activity. This review could further define the clinical rationale for the use of biologics in the treatment of dcSSc and could provide key details on the study protocol, design, and outcome reporting.

Potential Satellite Cell-Linked Biomarkers in Aging Skeletal Muscle Tissue: Proteomics and Proteogenomics to Monitor Sarcopenia.

Sarcopenia (Sp) is the loss of skeletal muscle mass associated with aging which causes an involution of muscle function and strength. Satellite cells (Sc) are myogenic stem cells, which are activated by injury or stress, and repair muscle tissue. With advancing age, there is a decrease in the efficiency of the regenerative response of Sc. Diagnosis occurs with the Sp established by direct assessments of muscle. However, the detection of biomarkers in real-time biofluids by liquid biopsy could represent a step-change in the understanding of the molecular biology and heterogeneity of Sp. A total of 13 potential proteogenomic biomarkers of Sp by their physiological and biological interaction with Sc have been previously described in the literature. Increases in the expression of GDF11, PGC-1α, Sirt1, Pax7, Pax3, Myf5, MyoD, CD34, MyoG, and activation of Notch signaling stimulate Sc activity and proliferation, which could modulate and delay Sp progression. On the contrary, intensified expression of GDF8, p16INK4a, Mrf4, and activation of the Wnt pathway would contribute to early Sp development by directly inducing reduced and/or altered Sc function, which would attenuate the restorative capacity of skeletal muscle. Additionally, tissue biopsy remains an important diagnostic tool. Proteomic profiling of aged muscle tissues has shown shifts toward protein isoforms characteristic of a fast-to-slow transition process and an elevated number of oxidized proteins. In addition, a strong association between age and plasma values of growth differentiation factor 15 (GDF-15) has been described and serpin family A member 3 (serpin A3n) was more secreted by atrophied muscle cells. The identification of these new biomarkers holds the potential to change personalized medicine because it could predict in real time the course of Sp by monitoring its evolution and assessing responses to potential therapeutic strategies.

Effects of Tribulus terrestris L. on Sport and Health Biomarkers in Physically Active Adult Males: A Systematic Review.

Tribulus terrestris L. (TT) is a plant used in traditional Chinese medicine, Ayurvedic medicine, and sports nutrition to improve health and performance. However, no conclusive evidence exists about the potential beneficial effects of TT on sport and health biomarkers in physically active adults. Based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the modified McMaster Critical Review Form for methodological quality assessment, we systematically reviewed studies indexed in Web of Science, Scopus, and PubMed, to assess the effects of TT on immunological, hematological, biochemical, renal, lipidic, hormonal behavior, and anti-inflammatory response in physically active adult males. Among 340 records identified in the search, a total of 7 studies met the inclusion and exclusion criteria. Overall, participants supplemented with TT displayed significant improvements in lipid profile. Inflammatory and hematological biomarkers showed moderate beneficial effects with no significant changes on renal biomarkers. No positive effects were observed on the immune system response. Additionally, no TT-induced toxicity was reported. In conclusion, there was no clear evidence of the beneficial effects of TT supplementation on muscle damage markers and hormonal behavior. More studies are needed to confirm the benefits of TT due to the limited number of studies available in the current literature.

Effectiveness of Comirnaty® Vaccine and Correlates of Immunogenicity and Adverse Reactions: A Single-Center Prospective Case Series Study.

The literature suggests that real-world data on the effectiveness and safety of the BNT162b2 vaccine depend on the characteristics of the vaccinated volunteers. The purpose of this study was to evaluate antibody responses and kinetics, established association with sociodemographic and clinical characteristics, and adverse reactions after complete vaccination with the BNT162b2 vaccine. A single-center prospective case series study was conducted with 112 eligible volunteers who were institutionalized elderly and health care workers with had a negative anti-SARS-CoV-2 IgG test prior to receiving the first dose of vaccine. At least one serological antibody test after each dose of vaccine was performed. Volunteers with a positive SARS-CoV-2 PCR test before vaccination were excluded. A chemiluminescent immunoassay anti-S1 antibody assay performed a serological evaluation. Both vaccine doses elicited positive IgG antibodies 3799.0 ± 2503.0 AU/mL and 8212.0 ± 4731.0 AU/mL after 20 days of the first and second doses of BNT162b2, respectively. Comirnaty® vaccine induced an immune response with antibody production against SARS-CoV-2 in 100% of participants, regardless of age (Spearman rho = −0.10, p-value = 0.312), body mass index (Spearman rho = 0.05, p-value = 0.640), blood group first dose (p-value for Kruskal−Wallis test = 0.093) and second dose (p-value for Kruskal−Wallis test = 0. 268), number of drugs (Spearman rho = −0.07, p-value = 0.490), and number of chronic diseases first dose (p-value for Kruskal−Wallis test = 0.632) and second dose (p-value for Kruskal−Wallis test = 0.510). IgG antibodies to SARS-CoV-2 were intensely elevated after the second administration of the BNT162b2 vaccine. The higher the titer of anti-peptide IgG antibodies generated after the first dose of vaccine, the higher the titer generated by the second dose of vaccine (Spearman rho = 0.86, p-value < 0.001) and the total antibody titer (Spearman rho = 0.93, p-value < 0.001). Furthermore, no serious adverse effects were reported among participants, although mild to moderate adverse effects (local or systemic) were reported after both doses of the BNT162b2 vaccine, being more frequent after the first dose of the vaccine. No participants showed a positive PCR. The BNT162b2 vaccine induces a robust and rapid antibody response regardless of participant characteristics. The second dose might be especially important because of the increased immunogenicity it produces and the possible temporal distancing of the interval between doses. In general, the vaccines were well tolerated.