ArticleAmerican journal of translational research2026
Effect of adding biologic agents to disease-modifying anti-rheumatic drugs for refractory chronic suppurative otitis media: comparative outcomes and cytokine-driven mechanisms.
Article in American journal of translational research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveTo evaluate systematically the efficacy of disease-modifying anti-rheumatic drugs (DMARDs) versus DMARDs plus biologics for refractory chronic suppurative otitis media (rCSOM), and to explore changes in systemic cytokine levels as surrogate markers of inflammatory modulation.
methodsThis retrospective study included 102 rCSOM patients (2020-2025). Patients were divided into a DMARDs-alone (DMA) group and a DMARDs-plus-biologics (Combined) group. Using 1:1 propensity score matching, 40 patients were included in each group. PRIMARY OUTCOME: otorrhea cessation rate at 12 weeks. SECONDARY OUTCOMES: hearing levels, including the pure tone average (PTA) and speech discrimination score (SDS); cytokine levels, including C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis factor-α (TNF-α); and quality of life, assessed using the Zurich Chronic Middle Ear Inventory (ZCMEI-21). Multivariate logistic regression was used to adjust for confounders. Adverse reactions were recorded.
resultsAt week 12 of treatment, the otorrhea cessation rate was markedly higher in the Combined group than the DMA group (P<0.05). The Combined group also had a lower PTA and lower CRP, IL-6, TNF-α levels, as well as lower ZCMEI-21 scores, but higher SDS values (all P<0.05). Multivariate logistic regression showed combination therapy was an independent protective factor for otorrhea cessation (OR=3.850, 95% CI: 1.101-13.466, P=0.035), while baseline CRP was an independent negative predictor of otorrhea cessation (OR=0.425, 95% CI: 0.268-0.672, P<0.001). The incidence of adverse events did not differ between groups (P=0.644).
conclusionCombining DMARDs with biologics improves outcomes in rCSOM compared to DMARDs alone, with a favorable safety profile. Baseline CRP independently predicts treatment response. Although the proposed mechanism is inferred from systemic cytokines in the absence of mucosal evidence, these findings support salvage immunomodulatory therapy and warrant future tissue-based validation.
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