Evidence map›Paper›PMID 42898317›Full record

SynthesisFrontiers in immunology2026

Efficacy and safety of intravenous immunoglobulin in systemic sclerosis: a systematic review and meta-analysis.

Jozélio Freire de Carvalho, Roberto Paulo Correia de Araujo, Maria Giovanna Danieli, Yehuda Shoenfeld

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Jozélio Freire de CarvalhoInstitute of Health Sciences, Federal University of Bahia, Salvador, Bahia, Brazil.
Roberto Paulo Correia de AraujoInstitute of Health Sciences, Federal University of Bahia, Salvador, Bahia, Brazil.
Maria Giovanna DanieliSOS Immunologia delle Malattie Rare e dei Trapianti, SOD Clinica Medica, Dipartimento di Medicina Interna, Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy.
Yehuda ShoenfeldReichman University, Herzelia, Israel.

Funding

Bronicky Family Foundation
6 · The paper itself

Abstract

Background: Systemic sclerosis (SSc) is a complex autoimmune disease mainly characterized by progressive fibrosis affecting the skin and internal organs. Although several immunosuppressive and targeted therapies are currently available, many patients continue to experience refractory manifestations. Intravenous immunoglobulin (IVIG) has been increasingly used as an adjunctive treatment in selected cases; however, its efficacy across different disease manifestations remains incompletely defined. Objective: To systematically evaluate the efficacy and safety of IVIG in patients with systemic sclerosis and to quantitatively synthesize available evidence regarding its effects on skin involvement, gastrointestinal manifestations, and inflammatory myopathy. Methods: A systematic review and meta-analysis were conducted according to PRISMA 2020 guidelines. MEDLINE/PubMed, Embase, LILACS, and the Cochrane Library were searched from January 1966 to May 2026. Studies evaluating IVIG in adult patients with systemic sclerosis were included. Randomized controlled trials, observational cohorts, pilot studies, and case series were eligible. Quantitative synthesis was performed using random-effects models and standardized mean differences (SMDs) with 95% confidence intervals (CIs). Results: Eleven studies were included in the systematic review. Six studies provided sufficient quantitative data for the meta-analysis of skin involvement, three for gastrointestinal outcomes, and two for muscle outcomes. The most common indications for IVIG therapy were cutaneous fibrosis, inflammatory myopathy, gastrointestinal involvement, and refractory musculoskeletal manifestations. Meta-analysis demonstrated a significant improvement in skin involvement assessed by the modified Rodnan Skin Score (SMD -0.59, 95% CI -0.95 to -0.22; p = 0.0019; I Conclusion: IVIG was associated with improvements in several clinical outcomes, particularly in observational studies, including skin fibrosis, gastrointestinal manifestations, and inflammatory myopathies. However, the only randomized placebo-controlled trial did not demonstrate significant short-term improvement in skin involvement at its primary endpoint. The available evidence suggests a potential adjunctive role for IVIG in selected patients.

Indexed as

Immunoglobulins, IntravenousImmunologic FactorsScleroderma, SystemicHumansTreatment OutcomeImmunoglobulins, IntravenousImmunologic Factorsinflammatory myopathyintravenous immunoglobulinsclerodermaskin fibrosissystemic sclerosis

Identifiers

PMID42898317
PMCPMC13677511

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.