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CT-P13 subcutaneous (SC), an SC formulation of the intravenous (IV) infliximab biosimilar CT-P13 IV, creates a unique exposure profile. The LIBERTY studies aimed to demonstrate superiority of CT-P13 SC vs placebo as maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC). Two randomized, placebo-controlled, double-blind studies were conducted in patients with moderately to severely active CD or UC and inadequate response or intolerance to corticosteroids and immunomodulators. All patients received open-label CT-P13 IV 5 mg/kg at weeks 0, 2, and 6. At week 10, clinical responders were randomized (2:1) to CT-P13 SC 120 mg or placebo every 2 weeks until week 54 (maintenance phase) using prefilled syringes. (Co-) primary end points were clinical remission and endoscopic response (CD) and clinical remission (UC) at week 54 (all-randomized population). Overall, 396 patients with CD and 548 patients with UC received induction treatment. At week 54 in the CD study, statistically significant higher proportions of CT-P13 SC–treated patients vs placebo-treated patients achieved clinical remission (62.3% vs 32.1%; P <.0001) and endoscopic response (51.1% vs 17.9%; P <.0001). In the UC study, clinical remission rates at week 54 were statistically significantly higher with CT-P13 SC vs placebo (43.2% vs 20.8%; P <.0001). Achievement of key secondary end points was significantly higher with CT-P13 SC vs placebo across both studies. CT-P13 SC was well tolerated, with no new safety signals identified. CT-P13 SC was more effective than placebo as maintenance therapy and was well tolerated in patients with moderately to severely active CD or UC who responded to CT-P13 IV induction. ClinicalTrials.gov , Numbers: NCT03945019 (CD) and NCT04205643 (UC). CT-P13 (infliximab, an anti–tumor necrosis factor therapy) is a biologic drug injected under the skin (ie, subcutaneously). Subcutaneous CT-P13 was more effective than a placebo and well tolerated in patients with moderate to severe Crohn's disease or ulcerative colitis. [ABSTRACT FROM AUTHOR]

The biobetter concept is now well defined. The compound must optimise clinical outcomes (efficacy, safety, immunity and/or patient comfort, assessed in terms of non-reliance on hospitalisation and compliance). CT-P13 SC has demonstrated and validated these points, and therefore meets the definition of a biobetter. Studies are currently underway to validate optimisations, the use of subcutaneous infliximab in ano-perineal lesions (APL) or post-operative, and the role of plasma level monitoring. [ABSTRACT FROM AUTHOR]

The coronavirus disease 2019 (COVID-19) pandemic has prompted significant changes in patient care in rheumatology and gastroenterology, with clinical guidance issued to manage ongoing therapy while minimising the risk of nosocomial infection for patients and healthcare professionals (HCPs). Subcutaneous (SC) formulations of biologics enable patients to self-administer treatments at home; however, switching between agents may be undesirable. CT-P13 SC is the first SC formulation of infliximab that received regulatory approval and may be termed a biobetter as it offers significant clinical advantages over intravenous (IV) infliximab, including improved pharmacokinetics and a convenient mode of delivery. Potential benefits in terms of reduced immunogenicity have also been suggested. With a new SC formulation, infliximab provides an additional option for dual formulation, which enables patients to transition from IV to SC administration route without changing agent. Before COVID-19, clinical trials supported the efficacy and safety of switching from IV to SC infliximab for patients with rheumatoid arthritis and inflammatory bowel disease (IBD), and SC infliximab may have been selected on the basis of patient and HCP preferences for SC agents. During the pandemic, patients with rheumatic diseases and IBD have successfully switched from IV to SC infliximab, with some clinical benefits and high levels of patient satisfaction. As patients switched to SC therapeutics, the reduction in resource requirements for IV infusion services may have been particularly welcome given the pandemic, facilitating reorganisation and redeployment in overstretched healthcare systems, alongside pharmacoeconomic benefits and a reduction in exposure to nosocomial infection. Telemedicine and contactless healthcare have been pushed to the forefront during the pandemic, and a lasting shift towards remote patient management and community/home-based drug administration is anticipated. SC infliximab supports the implementation of this paradigm for future improvements of healthcare value delivered. The accumulation of real-world data during the pandemic supports the high level of confidence, with patients, physicians, and healthcare systems benefitting from its uptake. [ABSTRACT FROM AUTHOR]

The COVID‐19 pandemic emphasized the utility of subcutaneous (SC) biologics for pressured healthcare systems. The first SC form of infliximab, CT‐P13 SC, provided safe and effective treatment for ankylosing spondylitis in our case series, with increased convenience relative to intravenous treatment benefitting patients both during the pandemic and beyond. [ABSTRACT FROM AUTHOR]

The COVID‐19 pandemic highlighted the benefits of subcutaneous (SC) administration for healthcare systems. The first SC infliximab, CT‐P13 SC, was safe and effective for the treatment of psoriatic arthritis. Observed patient preferences for continuing CT‐P13 SC suggest that patients receiving IV infliximab should be offered a switch to CT‐P13 SC. [ABSTRACT FROM AUTHOR]

Abstract The COVID‐19 pandemic highlighted the benefits of subcutaneous (SC) administration for healthcare systems. The first SC infliximab, CT‐P13 SC, was safe and effective for the treatment of psoriatic arthritis. Observed patient preferences for continuing CT‐P13 SC suggest that patients receiving IV infliximab should be offered a switch to CT‐P13 SC.

Abstract The COVID‐19 pandemic emphasized the utility of subcutaneous (SC) biologics for pressured healthcare systems. The first SC form of infliximab, CT‐P13 SC, provided safe and effective treatment for ankylosing spondylitis in our case series, with increased convenience relative to intravenous treatment benefitting patients both during the pandemic and beyond.