Background At EU marketing authorisation, safety data for CT-P13 (biosimilar infliximab) were limited, particularly in some indications, and uncommon adverse events (AEs) could not be evaluated among relatively small analysis populations. Objectives Our objective was to investigate the overall safety profile and incidence rate of AEs of special interest (AESIs), including serious infections and tuberculosis, in CT-P13-treated patients. Methods Data were pooled from six observational studies representing authorised indications of CT-P13 (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, adult and paediatric Crohn's disease and ulcerative colitis). Patients were analysed by indication and treatment (patients who received CT-P13 or those who switched from reference infliximab to CT-P13 ≤ 6 months prior to enrolment or during the study). Results Overall, 4393 patients were included (n = 3677 CT-P13 group; n = 716 switched group); 64.03% of patients had inflammatory bowel disease and 6.31% of patients were antidrug antibody positive. Overall, 32.94% and 9.58% of patients experienced treatment-emergent AEs (TEAEs) and treatment-emergent serious AEs, respectively. Across indications, TEAEs were more frequent with CT-P13 than with the switched group. Infections including tuberculosis were the most frequent serious AESI overall (2.48%) and by treatment group or indication. In total, 14 patients (0.32%) reported active tuberculosis. Overall incidence rates per 100 patient-years (95% confidence interval) were 3.40 (2.788-4.096) for serious infections including tuberculosis and 0.44 (0.238-0.732) for active tuberculosis. Infusion-related reactions were the second most frequent AESI following infection including tuberculosis. ConclusionThe CT-P13 safety profile appears consistent with previous studies for CT-P13 and reference infliximab, supporting the favourable risk/benefit balance for CT-P13 treatment.
Background:CT-P13 was the first approved biosimilar monoclonal antibody globally and is currently marketed in 88 countries, including the European Union (EU) and the United States (US). Since approval, 4 observational prospective cohort studies have been conducted in the EU, Canada and Korea to assess long term safety of CT-P13 in patients with Rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and psoriasis (PSO). Safety data from the 4 studies were pooled and analysed.Objectives:To evaluate the long-term safety of CT-P13 in patients with RA, AS, PsA and PSO in global real world, post-marketing studiesMethods:Safety data from patients registered in the 4 observational studies (KOREA PMS, CT-P13 4.2, CT-P13 4.4, and PERSIST) have been collected after marketing authorisation was granted. The incidence of Adverse Events of Special Interests (AESIs) from subjects with RA, AS, PsA and PsO who were treated at least 1 dose of CT-P13 with the data cut point of Dec27, 2017 were analysed.Results:A total of 1579 patients were treated with at least 1 dose of CT-P13 across the 4 studies (RA = 670; AS = 819; PsA/PsO = 90). Mean age (years) of patients per RA, AS and PsA/PSO indication was 54.5, 40.3 and 52.9, respectively. Average exposure duration (days) to CT-P13 in patients with RA, AS and PsA/PSO was 280.3, 254.0 and 322.1, respectively, and the mean maximum dose of CT-P13 (mg/kg) with RA, AS and PsA/PSO patients was 3.77, 4.51 and 4.31, respectively. Treatment emergent adverse events (TEAEs) were reported in 50.15%, 37.73% and 26.67% for RA, AS and PsA/PSO, respectively. Incidence of TEAEs in RA indication is consistent with the historical rate in this population. Treatment emergent serious adverse events (TESAEs) were reported for 12.39%, 4.52% and 3.33% for RA, AS and PsA/PSO patients, respectively. Incidence of TEAEs leading to discontinuation were 8.81%, 3.42% and 7.78% for RA, AS and PsA/PSO. Two deaths and 1 death were reported among RA and AS patients, respectively. The causes of death in RA patients were acute respiratory distress syndrome (ARDS) and bronchopneumonia; the cause of death in the AS patient was unknown. AESIs of CT-P13 were analysed in safety population who were treated with CT-P13 at least once by the data cut point. No events of serum sickness, haematologic malignancy, demyelinating disorder, sarcoidosis/sarcoidosis-like reaction were reported.Table 1 Incidence of AESIs AESIs/Number of patients (%)RAN=670ASN=819PsA/PSON=90[1] Serious infection including Tuberculosis (TB)27(4.03%)17(2.08%)1(1.11%)Active Tuberculosis3(0.45%)5(0.61%)0Acute hypersensitivity1(0.15%)1(0.12%)0Haematologic reaction8(1.19%)5(0.61%)2(2.22%)Systemic Lupus erythematosus/Lupus-like syndrome001(1.11%)Non-Haematologic Malignancy6(0.90%)00Hepatobiliary Event22 (3.28%)34(4.15%)0HBV reactivation01(0.12%)0Congestive Heart Failure01(0.12%)0 [1]6 patients of PSO were analysed with PsA patientsConclusion:The results of this analysis show that treatment with CT-P13 is well tolerated in patients with RA, AS,...
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