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<p>Mastocytosis is a rare disorder characterized by mast cell accumulation, often leads to severe symptoms that are refractory to conventional therapies. omalizumab, an anti-IgE monoclonal antibody, has shown promise in alleviating symptoms; however, its efficacy and safety remain unclear. This systematic review and meta-analysis evaluates the efficacy of omalizumab in patients with systemic and cutaneous mastocytosis. We searched multiple databases for studies assessing omalizumab’s effects in mastocytosis. Four studies (2 RCTs, 2 prospective cohorts; total <i>n</i> = 99 patients) met inclusion criteria. Outcomes included AFIRMM relative reduction, treatment response (complete/major/partial/no response), and safety aspects. Random-effects meta-analysis was performed for quantitative outcomes, with heterogeneity evaluated via I² statistics. Response rates varied: complete (1.5%, 95% CI: 0.00–0.56), major (3.34%, 95% CI: 0.16–0.53), and partial (1.59%, 95% CI: 0.05–0.19). No response was reported in 3.34% of cases. AFIRMM score was assessed in two of the included studies and was insignificant. omalizumab demonstrates a generally favorable safety profile and may offer symptomatic benefit in patients with mastocytosis, particularly in terms of relative symptom improvement. However, findings from the limited number of studies show variability in response rates and inconsistent AFIRMM score outcomes. Heterogeneity in response rates underscores the need for larger, standardized trials to confirm its role in therapy.</p>

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Clinical efficacy and safety of omalizumab in patients with mastocytosis: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2025年10月11日

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  • Ahmad M. Molhem,
  • Raneem O. Aldamen,
  • Amr Taher Masoud,
  • Qussai R. Abuelsamen,
  • Fai Mubarak Alsaleeli,
  • Omar M. Almomani,
  • Ayah E. Shawaqfeh,
  • Heba Bani Marie,
  • Rama A. AlHomoud,
  • Mujahed Nabeel Ibrahim Beitho,
  • Ahmed Ashraf Mohamed,
  • Tamara M. Molhem

摘要

Mastocytosis is a rare disorder characterized by mast cell accumulation, often leads to severe symptoms that are refractory to conventional therapies. omalizumab, an anti-IgE monoclonal antibody, has shown promise in alleviating symptoms; however, its efficacy and safety remain unclear. This systematic review and meta-analysis evaluates the efficacy of omalizumab in patients with systemic and cutaneous mastocytosis. We searched multiple databases for studies assessing omalizumab’s effects in mastocytosis. Four studies (2 RCTs, 2 prospective cohorts; total n = 99 patients) met inclusion criteria. Outcomes included AFIRMM relative reduction, treatment response (complete/major/partial/no response), and safety aspects. Random-effects meta-analysis was performed for quantitative outcomes, with heterogeneity evaluated via I² statistics. Response rates varied: complete (1.5%, 95% CI: 0.00–0.56), major (3.34%, 95% CI: 0.16–0.53), and partial (1.59%, 95% CI: 0.05–0.19). No response was reported in 3.34% of cases. AFIRMM score was assessed in two of the included studies and was insignificant. omalizumab demonstrates a generally favorable safety profile and may offer symptomatic benefit in patients with mastocytosis, particularly in terms of relative symptom improvement. However, findings from the limited number of studies show variability in response rates and inconsistent AFIRMM score outcomes. Heterogeneity in response rates underscores the need for larger, standardized trials to confirm its role in therapy.