Backgroundswitching from reference infliximab (RI) to biosimilar infliximab (BI) had no detrimental effects on efficacy and safety compared to continuous RI. However, long-term follow-up data is missing.Objectives: the aim of this study was to evaluate if BI is equivalent to RI to maintain patients with Ankylosing Spondylitis (AS) in clinical remission, in a long-term fashion.Methods: one hundred and nine consecutive unselected AS patients were investigated. All, followed-up at predefined times receiving RI (5mg/kg/8 weeks) and were naïve to other biologics. Patients who were in clinical remission were asked to switch from RI to BI using the same therapeutic dose. Patients switched to BI were compared with a match control group receiving continuous RI. During follow-up the demographic, clinical, laboratory parameters and comorbidities were all recorded for at least 18 months. Disease activity was measured using the Bath Ankylosing Spondylitis activity index (BASDAI), and the Ankylosing Spondylitis disease activity score (ASDAS), using the C-reactive protein. Remission was defined if patients achieved BASDAI <4 and ASDAS <1.3.Results: twenty-one patients were excluded, nine because had no clinical remission and twelve because refused to switch. Thus, 88 were evaluated. From those, 45 switched to BI, while 43 continued receiving RI. There were no differences between groups regarding demographic, clinical and laboratory parameters. All patients were in clinical remission (BASDAI <4 and ASDAS <1.3). During follow-up, five patients from the switched group and three from the maintenance group discontinued the study. Four patients receiving BI presented nocebo effects and were switched back to the RI. Three responded well, while the fourth did not. After 18 months of treatment, all patients in both groups remained in clinical remission. No significant adverse events were noted between groups.ConclusionBI is equivalent to RI in maintaining AS in clinical remission for at least 18 months.AcknowledgementWe have no acknowledegement for this abstractDisclosure of InterestsNone declared
Rheumatoid arthritis (RA) is an autoimmune disease that is characterised by synovial inflammation and progressive joint disorder with significant pain and stiffness, which lead to functional disability and systemic complications if left untreated. Although methotrexate (MTX) is the cornerstone in the RA therapy, it is ineffective or intolerable in up to 50% of patients. In addition, tumour necrosis factor (TNF) inhibitors which are regarded as the standard of care for those patients, have not been proven a panacea creating a therapeutic gap. In this direction, other cytokines such as the interleukin (IL)-6 in combination with MTX or as monotherapy have been approved. Sarilumab has already been approved for the treatment of moderate to severe RA, but more studies are on their way including polymyalgia rheumatica, giant cell arteritis, juvenile idiopathic arthritis, and indolent systemic mastocytosis. On the other hand, a study was prematurely discontinued after approximately 1.5 years, when the ankylosing spondylitis development program was discontinued due to lack of efficacy. Regarding safety, efficacy and tolerability of the molecule, three pivotal clinical trials have established sarilumab as one of the safe and efficacious choices for the treatment of RA (mobility, target and monarch trials). Significant decreases in progression of structural damage have been demonstrated. Infections and neutropenia are two of the most common adverse events. Sarilumab is beyond any doubt another molecule that can be added to the clinicians’ armamentarium for the treatment of patients with moderate to severe RA with a good safety and efficacy profile.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.