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Impact of Innovative Treatment Using Biological Drugs for the Modulation of Diffuse Cutaneous Systemic Sclerosis: A
Diego Fernández-Lázaro1,2, María Iglesias-Lázaro1, Evelina Garrosa2
1Department of Cellular Biology, Genetics, Histology and Pharmacology, Faculty of Health Sciences, University of Valladolid, Campus of Soria, 42004 Soria, Spain.
Abstract:
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.
Insights
Biological drugs show promising trends for improving skin and lung function in systemic sclerosis (SSc) patients, though not significantly impacting disability. These agents may offer a new anti-fibrotic strategy for diffuse cutaneous SSc (dcSSc).
Area of Science:
- Rheumatology and Immunology
- Pharmacology and Drug Discovery
Background:
- Systemic sclerosis (SSc) is an autoimmune connective tissue disease causing fibrosis.
- Current treatments for SSc are symptomatic; no cure exists.
- Biologics offer potential for effective, less toxic SSc management.
Approach:
- Systematic review of controlled trials (PRISMA guidelines) up to October 2022.
- Searched PubMed, Dialnet, Cochrane Library Plus for biologics (tocilizumab, belimumab, riociguat, abatacept, romilkimab) in diffuse cutaneous SSc (dcSSc).
- Assessed study quality using McMaster quantitative form and PEDro scale.
Key Points:
- Six studies involving 426 dcSSc patients were included.
- Non-significant improvement trends observed in modified Rodnan Scale, Forced Vital Capacity, and Carbon Monoxide Diffusion Test.
- No significant benefits noted for Health Assessment Questionnaire-Disability Index compared to controls.
Conclusions:
- Biological drugs may represent a novel therapeutic strategy for dcSSc.
- Considered as additional/adjunctive anti-fibrotic treatments.
- Further research can refine biologic use and optimize clinical trial design for dcSSc.
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