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Introduction <p>Data suggest that women and men differ in how they experience biological treatment. This post hoc analysis of the YU-MATTER study evaluated sex-related differences in patient satisfaction and perception when switching from adalimumab (reference or biosimilar) to CT-P17 (Yuflyma<sup>®</sup>; Celltrion, Inc.), a high-concentration, citrate-free adalimumab biosimilar.</p> Methods <p>This analysis used data from the observational, multicentre, prospective YU-MATTER study. Patients had inflammatory bowel disease or chronic inflammatory rheumatic disease and switched from adalimumab (reference or low-concentration [&lt; 50 mg/ml] biosimilar) to CT-P17. Patients completed online questionnaires monthly to month 3 (M3). The primary outcome was overall patient satisfaction (7-point Likert scale). Additional outcomes were expectations and perceptions of switching to CT-P17 (7- and 5-point Likert scale, respectively), beliefs about medicine (18-item Beliefs about Medicines Questionnaire), health literacy (16-item Health Literacy Survey Europe) and injection site reactions (pain and itching: 0–10 numerical rating scale; redness and haematoma: 4- and 3-point Likert scale, respectively).</p> Results <p>YU-MATTER enrolled 115 women and 117 men. More men than women reported satisfaction with CT-P17 treatment at M3 (82.1% vs 68.7%). Beliefs about medicines, health literacy, and patient expectations and perceptions of CT-P17 treatment did not differ significantly between sexes, although more women expected CT-P17 to be less painful (73.0% vs 59.0%;<i> p</i> = 0.077). At baseline, women reported significantly higher incidences of injection site redness (60.9% vs 48.7%) and haematoma (50.4% vs 26.5%) than men, with similar trends at M3 (40.0% vs 20.2% and 32.6% vs 8.5%, respectively), as well as significantly higher severity of injection site pain and itching. Both sexes reported fewer and less severe injection site reactions with CT-P17 at M3 compared with baseline adalimumab.</p> Conclusion <p>Most expectations and perceptions of CT-P17 treatment were similar between sexes, but women experienced more injection site reactions. Further research is needed to understand why women experience a higher incidence of these reactions with adalimumab and its biosimilars.</p> Trial Registration <p>Clinicaltrials.gov identifier NCT05427942 (registered June 22, 2022).</p>

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Sex Differences in Treatment Expectations, Satisfaction and Tolerance After Switching to CT-P17, an Adalimumab Biosimilar: A Post Hoc Analysis of the YU-MATTER Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月16日

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  • Laure Gossec,
  • Guillaume Bouguen,
  • Azeddine Dellal,
  • Lucile Foulley,
  • Caroline Habauzit,
  • Salim Benkhalifa,
  • Hubert Marotte

摘要

Introduction

Data suggest that women and men differ in how they experience biological treatment. This post hoc analysis of the YU-MATTER study evaluated sex-related differences in patient satisfaction and perception when switching from adalimumab (reference or biosimilar) to CT-P17 (Yuflyma®; Celltrion, Inc.), a high-concentration, citrate-free adalimumab biosimilar.

Methods

This analysis used data from the observational, multicentre, prospective YU-MATTER study. Patients had inflammatory bowel disease or chronic inflammatory rheumatic disease and switched from adalimumab (reference or low-concentration [< 50 mg/ml] biosimilar) to CT-P17. Patients completed online questionnaires monthly to month 3 (M3). The primary outcome was overall patient satisfaction (7-point Likert scale). Additional outcomes were expectations and perceptions of switching to CT-P17 (7- and 5-point Likert scale, respectively), beliefs about medicine (18-item Beliefs about Medicines Questionnaire), health literacy (16-item Health Literacy Survey Europe) and injection site reactions (pain and itching: 0–10 numerical rating scale; redness and haematoma: 4- and 3-point Likert scale, respectively).

Results

YU-MATTER enrolled 115 women and 117 men. More men than women reported satisfaction with CT-P17 treatment at M3 (82.1% vs 68.7%). Beliefs about medicines, health literacy, and patient expectations and perceptions of CT-P17 treatment did not differ significantly between sexes, although more women expected CT-P17 to be less painful (73.0% vs 59.0%; p = 0.077). At baseline, women reported significantly higher incidences of injection site redness (60.9% vs 48.7%) and haematoma (50.4% vs 26.5%) than men, with similar trends at M3 (40.0% vs 20.2% and 32.6% vs 8.5%, respectively), as well as significantly higher severity of injection site pain and itching. Both sexes reported fewer and less severe injection site reactions with CT-P17 at M3 compared with baseline adalimumab.

Conclusion

Most expectations and perceptions of CT-P17 treatment were similar between sexes, but women experienced more injection site reactions. Further research is needed to understand why women experience a higher incidence of these reactions with adalimumab and its biosimilars.

Trial Registration

Clinicaltrials.gov identifier NCT05427942 (registered June 22, 2022).