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P544 Impact of patient education on switch acceptance in IBD patients in remission, with infliximab originator switched for an infliximab biosimilar: a prospective study

A. Hastier-De Chelle*1, V. Cluzeau1, J. Condat1, N. Arab1, X. Hébuterne1, J. Filippi1

1Hôpital Archet 2, Alpes-Maritimes, Nice, France

Background

CT-P13, the first biosimilar to infliximab (IFX), has an efficacy and tolerance profile comparable to IFX originator, at a lower cost. Physicians are thus strongly encouraged to propose a biosimilar. However, for patients, the switch from IFX originator to a biosimilar is not always accepted. The aim of this study was to evaluate the impact of patient education (PE) on the acceptance of a switch from IFX originator to biosimilar in IBD patients treated with IFX originator.

Methods

In a monocentric prospective study, all IBD adult patients treated with IFX originator between June 2017 and June 2018, in clinical remission for at least 6 months, were asked to complete a questionnaire specifically designed for this study, to assess their knowledge on biosimilars and their acceptance of a switching strategy. Patients had the choice whether or not to accept the switch, with or without PE. The primary endpoint was the percentage of patients who accepted the switch, after receiving a PE session due to an initial refusal. Secondary endpoints were the evaluation of patient knowledge and feeling regarding biosimilar treatment; clinical remission, based on the Harvey–Bradshaw Index (score < 4) for CD and the partial Mayo score (< 2) for UC; biological remission: C reactive protein (N<5 mg/l) and faecal calprotectin (N<150 μg/g stool) and immunogenicity after the switch, trough levels of IFX (TLI) and anti-IFX antibodies (ATI).

Results

86 patients (median age: 44 years [19–79]) were included (36% UC and 64% CD). The switch was initially refused by 47% of patients. In this subgroup, 78% agreed to participate in an educational interview with the PE nurse; 68% finally accepted the switch. At Week 16, the persistence on biosimilar was 91%. At weeks 0, 8 and 16, respectively, Mayo score was 0.68 ± 0.69, 0.81 ± 0.95 and 0.57 ± 0.76 (p = 0.733) and Harvey–Bradshaw score was 0.88 ± 1.70, 1.95 ± 2.27 and 2.14 ± 2.36 (p = 0.134); CRP was 2.92 ± 4.52, 3.48 ± 5.99 and 4.33 ± 10.82 (p = 0.724); faecal calprotectin was 291 ± 402, 418 ± 596 and 427 ± 459 (p = 0.745); TLI was 5.00 ± 3.98, 4.81 ± 3.97 and 4.44 ± 3.34 (p = 0.642); no patients had immunisation after the switch; IBDQ was 182.61 ± 28 at W0 and 175 ± 34 for at W16 (p = 0.494). The evaluation on the knowledge of biosimilars at W0 showed that 77% of patients had never heard about it, 85% were in favour of the switch and 61% expressed fears about their use. At Week 16, the same evaluation showed that 84% of patients said they knew about biosimilars, 93% were in favour of the switch and 39% were still concerned about their use.

Conclusion

This study confirms the safety of switching infliximab by CT-P13 and demonstrates for the first time that PE plays a key role in switch acceptance by patients.