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. 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). 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. 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. Clinicaltrials.gov identifier NCT05427942 (registered June 22, 2022). Biological drugs are often used to treat inflammatory diseases. Biosimilars (a very similar version of the original drug) have been created, which are often more affordable than the original biological drug. CT-P17 is a biosimilar of adalimumab, one of the most widely used biologicals for inflammatory bowel disease and chronic inflammatory rheumatic diseases. CT-P17 requires only a small volume to be injected and does not contain citrate, a chemical contained in some biological drugs that may cause injection site reactions. The YU-MATTER study was conducted in patients with inflammatory bowel disease or chronic inflammatory rheumatic diseases in France who were switching to CT-P17 from another adalimumab formulation. Patients completed online questionnaires about their perceptions and expectations of treatment. This analysis of YU-MATTER compared the responses of women and men. There were no significant differences between women and men regarding their expectations of switching to CT-P17 treatment, perceptions of the switching process, medication beliefs, health literacy or overall treatment satisfaction. However, women reported injection site reactions, such as redness and swelling, more often than men, and also had more pain and itching with both their previous adalimumab treatment and CT-P17. In both sexes, all reactions were less common and less severe with CT-P17 than with the previous adalimumab formulation. More research is needed to discover why women experience more injection site reactions than men.
Gossec et al. (Mon,) studied this question.