ObjectiveCT-P13 is a biosimilar with comparable pharmacokinetics, efficacy and safety to its reference product (RP), infliximab. Studies have shown that switching from RP to CT-P13 does not reduce the effectiveness or safety of treatment.MethodsIn this retrospective real-world study, patients with inflammatory diseases treated with RP were switched to CT-P13 (n = 7) or continued on RP (n = 6). Clinical outcomes were compared between groups after four treatment cycles.ResultsCT-P13 demonstrated comparable effectiveness to its RP. All patients who switched to the biosimilar maintained or improved their clinical response, including two who remained in remission and three who moved into remission. In the RP group, five patients maintained their clinical response, with one achieving remission. Safety profiles were similar between groups.ConclusionsCT-P13 was equally effective as infliximab RP in this real-world study. CT-P13 is a valid, lower-cost alternative for patients currently receiving RP.

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BackgroundBrentuximab vedotin (SGN-35) is a treatment option for patients with relapsed or refractory Hodgkin’s lymphoma (HL) and systemic anaplastic large-cell lymphoma (ALCL), with only two phase II studies.PurposeTo evaluate the effectiveness and safety of SGN-35 in patients with relapsed or refractory HL and ALCL.Material and methodsType of study: retrospective observational cohort study.Inclusion criteria: patients with relapsed or refractory HL and ALCL, treated with SGN-35 in monotherapy from 05/2012 to 09/2014.Variables: age, sex, type of lymphoma, stage and International Prognostic Index (IPI score); number of prior courses of chemotherapy, autologous stem-cell transplantation (auto-SCT) and clinical response to prior treatment; number of cycles, dose reductions, clinical response according to the Revised Response Criteria for Malignant Lymphoma: complete remission (CR), partial remission (PR), stable disease (SD) and progressed disease (PD). Incidence and severity of side effects (CTCAE v4.03 criteria).ResultsWe included 5 patients (3 women, 2 men) aged 47 (30; 52) years. 4 patients suffered from HL, stages II-A, II-B, III-A, IV-B, and 1 ALCL stage IV-A. The IPI score was: III 2 patients, IV 1 patient (2 patients not specified).Our patients had received 2 (2; 4) chemotherapy cycles before SGN-35 and 3 of them had undergone an auto-SCT. Clinical response to prior therapy was CR in 2 and PR in 3 patients.After 4 (2; 16) cycles (1 patient with a 17% reduction of dose because of his previous hepatic impairment) 2 patients achieved CR, 1 PR and 1 PD. At the end of the follow-up period, 3 patients carried on with the treatment (1 without evaluation of the response) and 2 patients had died (1 CR and 1 PD) with a time to progression of 2.5 (2; 3) months.1 patient suffered from side effects: facial rash and a post-infusion reaction grades I-II.ConclusionIn our population 3 of 5 patients treated with SGN-35 achieved an objective response for 2.5 months, with favourable safety profile.References and/or AcknowledgementsJCO30 (18):2190–6JCO30 (18):2183–9No conflict of interest.

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