ObjectivesTo assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions.MethodsThis open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group).ResultsOverall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively).ConclusionsComparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years.Trial registration numberNCT01571219; Results.

ObjectivesTo investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS).MethodsThis open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102. Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20. Antidrug antibodies (ADAs) were measured using an electrochemiluminescent method. Data were analysed for patients treated with CT-P13 in the main PLANETAS study and the extension (maintenance group) and those who were switched to CT-P13 during the extension study (switch group).ResultsOverall, 174 (82.9%) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled. Among these, 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP. In these maintenance and switch groups, respectively, ASAS20 response rates at week 102 were 80.7% and 76.9%. ASAS40 and ASAS partial remission were also similar between groups. ADA positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively.ConclusionsThis is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS. In the maintenance group, CT-P13 was effective and well tolerated over 2 years of treatment.Trial registration numberNCT01571206; Results.

BackgroundPain related to temporomandibular disorders (TMD) is a common problem in modern societies. The aim of the article is to present the concepts of TMD pain clinical management.MethodsA survey was performed using the PubMed, SCOPUS and CINAHL databases for documents published between 1994 and 2014. The following search keywords were selected using MeSH terms of the National Library of Medicine in combination: TMD pain, TMD, TMJ, TMJ disorders, occlusal splint, TMD physiotherapy, TMJ rheumatoid disorders and TMJ surgery. Original articles and review papers which presented the clinical relevance and practical validity regarding the possibility of application in TMD management have been included. Authors have excluded articles without outstanding practical aspect and evidence-based background. A first selection was carried out by reviewing titles and abstracts of all articles found according to the criteria. After that the full texts of potentially suitable articles were assessed. In line with these criteria, among 11467 results the writers have included 66 papers.ResultsThe most commonly reported conservative treatments are massage therapy and individually fabricated occlusal splints. In addition to massage, other popular methods include manual therapy and taping, warming/cooling of aching joints, and light and laser therapy. Drugs are also commonly used. In the most severe cases of the temporomandibular joint degeneration, surgical restoration of the joint is sometimes applied.ConclusionsThe authors concluded that conservative treatment including counselling, exercises, occlusal splint therapy, massage, manual therapy and others should be considered as a first choice therapy for TMD pain because of their low risk of side effects. In the case of severe acute pain or chronic pain resulting from serious disorders, inflammation and/or degeneration pharmacotherapy, minimally invasive and invasive procedures should be considered.