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News Article | May 12, 2017
Site: www.businesswire.com

INCHEON, South Korea--(BUSINESS WIRE)--Detailed results from NOR-SWITCH, a randomized, double-blind, switching study of biosimilar infliximab, CT-P13 (Remsima®/ Inflectra™) were published in the prestigious journal The Lancet. Sponsored by the Norwegian government, the study explored the impact of switching adult patients who were stable on reference infliximab to Celltrion Healthcare’s biosimilar CT-P13. The results demonstrate that CT-P13 is not inferior to continued treatment with the reference product and that patients can be safely switched. 1 Dr Kwon, Medical Director at Celltrion Healthcare said: “ The publication of the NOR-SWITCH data in The Lancet marks another important milestone on the path to increasing physician confidence in using biosimilar infliximab when looking to switch their patients.” Following presentations at both the 2016 United European Gastroenterology (UEG) Week and the American College of Rheumatology (ACR) Annual Meeting, the findings from the study revealed that out of the 50% of patients switched to CT-P13, the proportion of patients with disease worsening were comparable to those who remained on reference infliximab (29.6 and 26.2% respectively.) The data discontinuation rates due to a lack of efficacy for reference infliximab and biosimilar infliximab were eight and three respectively. The time to study drug discontinuation was almost identical between the two groups, with similar overall remission rates and frequencies of adverse events also observed. 1 Tore K. Kvien, Head of Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, and the lead author of the NOR-SWITCH study, also said: “ NOR-SWITCH results show that efficacy and safety were comparable between patients switched to CT-P13 and those who continued treatment with reference infliximab, proving that patients can be safely switched to CT-P13. As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.” The Norwegian government wanted to determine the impact of switching adult patients who were stable on reference infliximab to biosimilar (CT-P13), and funded NOR-SWITCH to evaluate this across all inflammatory diseases for which infliximab is approved (Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis). Involving nearly 500 patients, the study was designed by a multidisciplinary and multiregional project group with special competence in performance of strategy trials, immunogenicity, and statistics led by Professor Tore Kvien at the Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. Additionally, the group consisted of representatives from the three relevant patient organisations.2 CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe. Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ The Lancet is one of the world's leading independent general medical journal. The peer-reviewed journal publishes medical news, original research, and reviews on all aspects of clinical medicine and International Health. The Lancet has an Impact Factor of 44.002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Available at: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [accessed May 2017]. 2 GAFPA. NOR-SWITCH. Available at: http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2016/09/GAfPA_Norswitch_Sept.-2016.pdf [accessed May 2017].

Sponsorizzato dal governo norvegese, lo studio ha esplorato l’impatto del passaggio al biosimilare infliximab CT-P13 di Celltrion Healthcare nei pazienti adulti in condizioni stabili trattati con il prodotto originale infliximab. I dati dimostrano che CT-P13 non è inferiore al trattamento continuativo con infliximab originale e che i pazienti possono passare da una terapia all'altra in tutta sicurezza. 1 A seguito di presentazioni tenutesi in occasione della 2016 United European Gastroenterology (UEG) Week e dell’incontro annuale dell’American College of Rheumatology (ACR), i dati dello studio hanno rivelato che nel 50% di pazienti passati a CT-P13, la proporzione di pazienti che hanno dimostrato un peggioramento della malattia era paragonabile a quelli che continuavano ad essere trattati con infliximab originale (29,6 e 26,2%, rispettivamente). I tassi di sospensione dei dati dovuta ad una mancanza di efficacia per infliximab orginale e infliximab biosimilare erano pari a otto e tre, rispettivamente. È risultato inoltre che il tempo necessario per studiare la sospensione del farmaco sperimentale era quasi identico per entrambi i gruppi, con simili tassi di remissione e frequenza di eventi avversi complessivi. 1 Il Professor Tore Kvien, responsabile del dipartimento di reumatologia del Diakonhjemmet Hospital di Oslo, in Norvegia, e responsabile dello studio NOR-SWITCH, ha inoltre dichiarato: “ I risultati di NOR-SWITCH mostrano che la sicurezza e l’efficacia erano paragonabili fra pazienti che sono passati a CT-P13 e quelli che continuavano il trattamento con infliximab originale, provando che i pazienti possono passare a CT-P13 in tutta sicurezza. Va tuttavia ricordato che questi dati si riferiscono specificamente a CT-P13 e non sono trasferibili ad altri biosimilari”. Per determinare l’impatto del passaggio al biosimilare infliximab (CT-P13) nei pazienti adulti in condizioni stabili precedentemente trattati con il prodotto originale, il governo norvegese ha finanziato lo studio NOR-SWITCH per valutare questa opzione in tutte le patologie infiammatorie per le quali infliximab è approvato (morbo di Crohn, colite ulcerativa, artrite reumatoide, spondiloartrite, artrite psoriasica o psoriasi cronica a placche). CT-P13, sviluppato e prodotto da Celltrion, Inc., è stato il primo anticorpo monoclonale biosimilare approvato dall'Agenzia europea per i medicinali (EMA). È indicato per il trattamento di otto malattie autoimmuni, inclusa l'artrite reumatoide e le malattie infiammatorie intestinali. Ha ricevuto l'approvazione dell'EMA con il nome commerciale Remsima® nel mese di settembre del 2013 ed è stato lanciato in Europa agli inizi del 2015. La FDA statunitense ha approvato CT-P13 di Celltron nel mese di aprile 2016 con il nome commerciale Inflectra™. CT-P13 di Celltron è approvato in oltre 79 paesi (dati aggiornati al mese di gennaio 2017) inclusi Stati Uniti, Canada, Giappone e tutta l'Europa. Celltrion Healthcare effettua a livello mondiale attività di marketing, vendita e distribuzione dei biofarmaci sviluppati da Celltrion, Inc. tramite un'estesa rete internazionale che comprende più di 120 paesi diversi. I prodotti di Celltrion Healthcare sono realizzati a partire da colture cellulari di mammiferi in avanzate strutture studiate e realizzate per la conformità agli standard cGMP della FDA statunitense e agli standard GMP della UE. Per ulteriori informazioni visitare il sito http://www.celltrionhealthcare.com/ 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Disponibile su: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [ultimo accesso maggio 2017].

Mjaavatten M.D.,Diakonhjemmet Hospital | Bykerk V.P.,Hospital for Special Surgery
Best Practice and Research: Clinical Rheumatology | Year: 2013

New classification criteria for rheumatoid arthritis (RA) were presented by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) in 2010, aiming for early identification of patients at risk of developing persistent and erosive arthritis. Since their publication, the criteria have been extensively validated against several reference standards, but there is still debate regarding how the criteria should be implemented in studies and clinical care. We present an overview of the published validation studies and discuss the strengths and limitations of the classification criteria, as well as whether the criteria are ready for diagnostic purposes in clinical practice. © 2013 Elsevier Ltd. All rights reserved.

Kjeken I.,Diakonhjemmet Hospital
Scandinavian Journal of Occupational Therapy | Year: 2011

Aims: The aims of this study were to develop recommendations for occupational therapy assessment and design of hand exercise programmes in patients with hand osteoarthritis. Methods: An expert group followed a Delphi procedure to reach consensus for up to 10 recommendations for assessment and exercises, respectively. Thereafter, an evidence-based approach was used to identify and appraise research evidence supporting each recommendation, before the recommendations were validated by the expert group. Results: The process resulted in 10 recommendations for assessment and eight for design of exercise programmes. The literature search revealed that there is a paucity of clinical trials to guide recommendations for hand osteoarthritis, and the evidence for the majority of the recommendations was based on expert opinions. Also, even if a systematic review demonstrates some evidence for the efficacy of strength training exercises in hand OA, the evidence for any specific exercise is limited to expert opinions. Conclusions: A first set of recommendations for assessment and exercise in hand osteoarthritis has been developed. For many of the recommendations there is a paucity of research evidence. High-quality studies are therefore needed to establish a high level of evidence concerning functional assessment and the effect of hand exercises in hand osteoarthritis. © Informa Healthcare.

Haugen I.K.,Diakonhjemmet Hospital | Boyesen P.,Diakonhjemmet Hospital
Arthritis Research and Therapy | Year: 2011

Hand osteoarthritis (OA) is very frequent in middle-aged and older women and men in the general population. Currently, owing to high feasibility and low costs, conventional radiography (CR) is the method of choice for evaluation of hand OA. CR provides a two-dimensional picture of bony changes, such as osteophytes, erosions, cysts, and sclerosis, and joint space narrowing as an indirect measure of cartilage loss. There are several standardized scoring methods for evaluation of radiographic hand OA. The scales have shown similar reliability, validity, and sensitivity to change, and no conclusion about the preferred instrument has been drawn. Patients with hand OA may experience pain, stiffness, and physical disability, but the associations between radiographic findings and clinical symptoms are weak to moderate and vary across studies. OA is, indeed, recognized to involve the whole joint, and modern imaging techniques such as ultrasound (US) and magnetic resonance imaging (MRI) could be valuable tools for better evaluation of hand OA. Standardized scoring methods have been proposed for both modalities. Several studies have examined the validity of US features in hand OA, whereas knowledge of the validity of MRI is more limited. However, both synovitis (detected by either US or MRI) and MRI-defined bone marrow lesions have been associated with pain, indicating that treatment of inflammation is important for pain management in hand OA. Both US and MRI have shown better sensitivity than CR in detection of erosions, and this may indicate that erosive hand OA may be more common than previously thought. © 2011 BioMed Central Ltd.

Uhlig T.,Diakonhjemmet Hospital
Best Practice and Research: Clinical Rheumatology | Year: 2012

Tai Chi and yoga are complementary therapies which have, during the last few decades, emerged as popular treatments for rheumatologic and musculoskeletal diseases. This review covers the evidence of Tai Chi and yoga in the management of rheumatologic diseases, especially osteoarthritis of the knee, hip and hand, and rheumatoid arthritis. There is evidence that Tai Chi and yoga are safe, and some evidence that they have benefit, leading to reduction of pain and improvement of physical function and quality of life in patients. Recommendations for Tai Chi in knee osteoarthritis have recently been issued by the American College of Rheumatology. To allow broader recommendations for the use of Tai Chi and yoga in rheumatic diseases, there is a need to collect more evidence researched with larger randomised controlled trials. © 2012 Elsevier Ltd. All rights reserved.

Putrik P.,Maastricht University | Putrik P.,Diakonhjemmet Hospital | Putrik P.,Jyvaskyla Central Hospital
Annals of the rheumatic diseases | Year: 2014

METHODS: A cross-sectional study among 46 European countries. One expert from each country completed a questionnaire on criteria regulating the start, maintenance/stop and switch of reimbursed bDMARDs. A composite score was developed to evaluate the level of restrictions in prescription of a first bDMARD (0=highly restricted, 5=most liberal). The level of restrictiveness was correlated with national socioeconomic welfare indicators.RESULTS: In 10 countries (22%), no bDMARD was reimbursed. Among 36 countries with at least one biologic reimbursed, 23(64%) had no requirement for disease duration to initiate a biologic. Half of the countries required a failure of two synthetic DMARDs to qualify for therapy. 31 countries specified a minimum level of disease activity to be fulfilled and in 20 (56%) countries cut-off for disease activity score with 28-joint assessment was higher than 3.2. Four countries (11%) had the maximum composite score (most liberal) and 20 (56%) scored between 0 and 2 (more restrictive). Criteria for initiation of a bDMARD were negatively associated with countries' socioeconomic welfare (-0.34 to -0.64), and a moderate positive correlation was found between the composite score and welfare indicators (0.59-0.72). Only some countries had regulations for stopping (n=14(39%)) or switching (n=19(53%)).CONCLUSIONS: Clinical criteria regulating prescription of bDMARDs in RA differ significantly across Europe. Countries with lower socioeconomic welfare tend to have stricter eligibility criteria, pointing to inequities in access to treatment.OBJECTIVES: To explore criteria regulating treatment with reimbursed biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) across Europe and to relate criteria to indicators of national socioeconomic welfare. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Hammer H.B.,Diakonhjemmet Hospital | Kvien T.K.,Diakonhjemmet Hospital
Arthritis Research and Therapy | Year: 2011

Introduction: The primary objectives were to explore the associations between a comprehensive ultrasonographic (US) assessment of joints, tendons and bursae and previously described reduced joint counts (7-, 12-, 28- and 44-joint score) as well as to assess the sensitivity to change of these different US joint combinations during biological treatment.Methods: Twenty patients with rheumatoid arthritis (RA) were examined by US (B-mode (BM) and power Doppler (PD)) with use of a semi-quantitative (0 to 3) score of 78 joints, 36 tendons/tendon groups and two bursae (hereafter described as the 78-joint score) at baseline and 1, 3, 6 and 12 months after initiating treatment with adalimumab. BM and PD scores for the different joint combinations were generated.Results: The reduced joint scores had high correlation coefficients with the 78-joint score at all examinations (range 0.79 to 0.99 for BM and 0.77 to 0.99 for PD, each P < 0.001) and sum BM and PD scores of all the different joint combinations improved significantly during follow-up (P ≤ 0.05 to 0.001).Conclusions: The reduced joint combinations were highly associated to the 78-joint score. Furthermore, all the joint combinations presently explored responded well to biological treatment. This indicates that an approach focusing on few joints and tendons gives equivalent information about the inflammatory activity in RA patients as a comprehensive US examination. The optimal combination of joints and tendons for a valid, reliable and feasible US measurement should be further explored to define a US score for follow-up of RA patients on biological treatment. © 2011 Hammer et al.; licensee BioMed Central Ltd.

Lie E.,Diakonhjemmet Hospital | Lie E.,Copenhagen University | Lie E.,University of Cardiff
Annals of the rheumatic diseases | Year: 2014

OBJECTIVE: Domains identified as a result of qualitative research and Delphi exercises to assess rheumatoid arthritis (RA) flare include pain, function, swollen and tender joints, patient and physician global, laboratory measures, participation, stiffness, self-management and fatigue. Here we examine aspects of construct and content validity of these domains in a longitudinal observational study.METHODS: A total of 1195 patients with RA treated with non-biological disease-modifying antirheumatic drugs (DMARDs) or biologics were eligible for the analyses. Working definitions of 'flare' included patient-reported worsening between 3 and 6 months (primary) and treatment change at 6 months (DMARDs and/or systemic corticosteroids) (secondary). Available outcome measures were mapped to the flare domains. Changes between 3 and 6 months were compared between patients with and without 'flare'. Convergent and divergent construct validity and content validity were assessed by correlation analyses and logistic regression analysis, respectively.RESULTS: Applying the flare working definition based on patient-reported worsening, standardised mean differences (SMDs) were >0.5 for the majority of outcomes. The largest SMDs were observed for Pain visual analogue scale (1.30), SF-36 Bodily pain (1.24), Patient global (1.20) and morning stiffness intensity (1.17). The flare working definition based on treatment change yielded lower SMDs (<0.5 for most variables). Consistently stronger intradomain than corresponding interdomain correlations supported convergent and divergent validity of the domains.CONCLUSIONS: Probing a flare definition via outcome measures, the identified flare domains discriminated well between patients with and without worsening. Interdomain and intradomain correlation and logistic regression analyses provide further support for construct and content validity of the identified flare domains. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

News Article | November 12, 2016
Site: www.eurekalert.org

WASHINGTON -- While patients with inflammatory rheumatic diseases such as rheumatoid arthritis (RA) or spondyloarthritis are at increased risk for cardiovascular disease (CVD), too few are prescribed preventive medications or meeting target goals to prevent heart-related events, according to new research findings presented this week at the 2016 ACR/ARHP Annual Meeting in Washington. RA is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Inflammation may also affect internal organs. An estimated 1.3 million Americans have RA. Spondyloarthritis are inflammatory diseases that include ankylosing spondylitis (AS), psoriatic arthritis (PsA), reactive arthritis and others. These diseases often affect the entheses, or areas where ligaments and tendons attach to bones. Both anti-hyperintensive (anti-HT) and lipid-lowering therapies (LLT) are widely available and effective at preventing CVD. However, recent research shows that the number of RA patients who receive these medications is less than optimal. It has been unclear whether patients with spondyloarthropathies (SpA) also receive inadequate CVD-preventive measures. To analyze the extent of the problem, researchers at Diakonhjemmet Hospital in Norway conducted a large cohort study to evaluate the rate of indications for anti-HT and/or LLT among inflammatory joint disease patients, the rate of anti-HT and LLT initiation, and the blood pressure (BP) and low-density lipoprotein cholesterol (LDL) goal attainment for patients who did receive CVD risk management. The researchers gathered data from the Norwegian Collaboration on Cardiovascular Disease in Patients with Rheumatic Joint Diseases project, or NOCAR. "There is a huge, unmet need for CVD-preventive measures in patients with inflammatory joint disease who are at high risk for CVD," said Anne Grete Semb, MD, consultant cardiologist at Diakonhjemmet Hospital and a lead author of the study. "There may be many reasons for this. In our nationwide NOCAR project, we have shown that recording of CVD risk factors and performance of CVD risk evaluation in patients with inflammatory joint diseases in rheumatology outpatient clinic is feasible. This is the important first step in CVD prevention, and it may lead to improvement of CVD preventive medication in patients with inflammatory joint diseases." A total of 2.647 patients with inflammatory joint diseases were included in the study. These comprised 1,696 with RA, 445 with AS, 376 with PsA and 130 with SpA. The researchers defined the need for anti-HT as patients having either a BP greater than or equal to 140/90mmHg, treated with anti-HT medication or self-reported hypertension. Patients with less than 140/90mmHg were recognized as having attained their BP goal if the patient was using anti-HT treatment. Ten-year risk of a fatal CVD event was estimated using the Systematic COronary Risk Evaluation (SCORE) tool, the European CVD risk calculator. According to CVD management guidelines, patients with diabetes, hyperlipidemia or a SCORE of greater than or equal to five percent are at high risk for CVD, and should receive LLT with an LDL target of less than 2.6 mmol/L (100 mg/dl). Patients with established CVD or a SCORE of greater than or equal to 10 percent are at very high CVD risk, and should be treated to reach an LDL target of less than 1.8 mmol/L (70 mg/dl). Rates of CVD risk and target attainment were calculated for the whole cohort, and then compared across inflammatory joint disease groups using logistic regression adjusted for age and sex. Of the patients included, 53.2 percent had an indication for anti-HT. This indication was significantly higher in RA (57 percent) and PsA (57 percent). Among patients with an indication for anti-HT, only 59 percent received the treatment and half attained the BP target. In addition, 24.1 percent had an indication for LLT, with comparable indications for all patient groups, except for a low percentage of those with AS, or 14.4 percent. Of those indicated for LLT, 55.6 percent had high CVD risk, most frequently patients with PsA, and 43.7 percent had very high CVD risk, most frequently patients with AS. Half of the patients with an LLT indication received this therapy. Treatment rates were higher for those with very high CVD risk than those at high risk. In total, 16.8 percent of the patients who received LLT achieved LDL targets. LDL goal attainment was notably high for the PsA patients, and higher in patients with high CVD risk compared to those with very high risk. While patients with inflammatory joint diseases often have an indication for CVD-preventive medications, they're prescribed too infrequently, the study's findings showed. In addition, too few patients who do start either anti-HT medication or LLT attain their treatment goals. "There are several important questions remaining in the field of cardio-rheumatology. It will be important to investigate novel strategies that can increase the number of patients who receive CVD risk assessments according to international recommendations," said Dr. Semb. "We hope that similar strategies as used in the NOCAR project can be implemented in other countries, and thus improve CVD risk assessment and ultimately reduce the CVD risk in patients with inflammatory joint diseases. After risk evaluation has been performed, there are still uncertainties about who has responsibility to start preventive measures. In most countries, this is the task of primary-care physicians. Our goal was also to raise awareness of the increased risk of CVD among health care providers and patients to facilitate the implementation of preventive measures." About the American College of Rheumatology Headquartered in Atlanta, Ga., the American College of Rheumatology is an international medical society representing over 9,400 rheumatologists and rheumatology health professionals with a mission to Advance Rheumatology! In doing so, the ACR offers education, research, advocacy and practice management support to help its members continue their innovative work and provide quality patient care. Rheumatologists are experts in the diagnosis, management and treatment of more than 100 different types of arthritis and rheumatic diseases. For more information, visit http://www. . The ACR/ARHP Annual Meeting is the premier meeting in rheumatology. With more than 450 sessions and thousands of abstracts, it offers a superior combination of basic science, clinical science, tech-med courses, career enhancement education and interactive discussions on improving patient care. For more information about the meeting, visit http://www. , or join the conversation on Twitter by following the official #ACR16 hashtag.

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