A prospective observational study with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC) patients switched from infliximab to CT-P13 treatment was carried out at Hospital Universitario Virgen Macarena, Seville, Spain, and reviewed up to 24 months. The primary endpoint was to analyse the loss of response to infliximab after switching. A loss of response was considered as the Harvey–Bradshaw (HB) index >4 for CD, partial Mayo score (PMS) >2 for UC, steroid use or surgery related to the activity of the disease and/or infliximab dose increase during the follow up.
A total of 100 patients were included (64 with CD and 36 patients with UC). In CD patients according to Montreal Classification: A2 71.9%, L2 42.2%, B1 60.9%, and perineal disease 43.8%. In UC: E1 36.1% and S2 47.2%.
At the beginning of the study, 78% of patients were in remission. At 12, 18 and 24 months, 69.6%, 69.9% and 68.5% of them were still in remission, respectively (p = 0.038). A total of 22% of the patients (16 CD and 6 UC), needed to have their dose increased during the 2 years of follow up. After the dose increase, 60% were in remission. 72% remained on CT-P13 during the 2 years of follow up. A total of 28% discontinued therapy due to a loss of response (15%), adverse events (AEs) (4%) or clinical remission (8%).
In the CD group, the median duration of ongoing originator infliximab treatment at the beginning of the study was 70 months (43–85) and 79.7% of patients were in remission. At 2-years follow up, 25% of patients discontinued CT-P13 (15.6% loss of response, 4.7% clinical remission, 3.1% AEs and 1.6% other medical indication). From the patients who continued using CT-P13 after the switch, 67.7%, 67.7% and 65.6% were in remission at 12, 18 and 24 months, respectively (p = 0.027). The HB index did not show significant changes over 24 months; the median HB index (95% CI) was: 1 (1–3), 2 (1–4), 1 (1–2) and 1 (1–2) at baseline, 12, 18 and 24 months, respectively (p = 0.128)
In the UC group, the median duration of ongoing originator infliximab treatment at the beginning of the study was 50 (22–75) months and 75% of patients were in remission. At 2-years follow up, 33.33% of patients discontinued CT-P13 (13.9% loss of response, 13.9% remission evidenced by mucosal healing and 5.6% AEs). From the patients who continued using CT-P13 after the switch, 74.2%, 74.2% and 74.2% were in remission at 12, 18 and 24 months, respectively (p = 0.948). The median (95% CI) of the PMS decreased significantly during the 24 months of follow up (p⩽0.001): 2 (1–3), 2 (1–2), 1 (0–1) and 1 (0–1) at baseline, 12, 18 and 24 months respectively.
C-reactive protein and infliximab drug levels did not show significant changes. Two patients developed low levels of anti-drug antibodies. AEs were reported in 14% of patients: 1 skin reaction, 1 asthenia, 2 headaches, 2 paresthesias during infusion, 1 Sweet’s syndrome, 1 polyarthralgia, 1 vaginal infection, 1 Herpes simplex infection, 1 candida infection, 1 psoriasis case, and 2 palpitations cases.
The present data indicate a statistically significant global loss of remission at the 2-year follow up (10%). These values are consistent with the ones in the literature since the incidence of loss of response varies between 10%–20% in clinical trial and 13%–30% in clinical practice. The annual risk of loss of response was suggested to be 13%–15% patients/year. However, the loss of response cannot be attributed to the medication alone. A total of 30.7% of the patients in this study had low infliximab levels during the follow up, and that could explain this loss of response.
The study has some limitations. First, the heterogeneous sample with a median time of previous treatment of 58 months. Other limitations were that faecal calprotectin and infliximab levels were not measured (the latter during the first year after the switch).
The authors concluded that ‘most of the patients switching from original infliximab were maintained on CT-P13 at 2 years of follow up with a good profile of efficacy and safety’.
Conflict of interest
The authors of the research paper [1] reported conflict of interest, including participation in advisory boards and having received financial support from Kern Pharma to attend scientific meetings. For full details of the authors’ conflict of interest, see the research paper [1].
Abstracted by Drs María Belvis Jiménez and María Fernanda Guerra Veloz, Virgen Macarena University Hospital, Seville, Spain.
Editor’s comment
Readers interested to learn more about switching to rituximab biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar
Switching from the infliximab reference product to CT-P13 in patients with rheumatoid arthritis or ankylosing spondylitis: results of the PLANETAS and PLANETRA extension studies
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Reference
1. Guerra Veloz MF, Belvis Jiménez M, Valdes Delgado T, et al. Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data. Therap Adv Gastroenterol. 2019;12:1756284819858052.
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