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Item Approaches to optimising access to NICE-approved biologic anti-TNFs for patients with rheumatoid arthritis with moderately active disease(2023)Abstract Background: Rheumatoid arthritis (RA) is a chronic inflammatory disease that is associated with joint pain and stiffness. Biologics represent some of the most effective treatments for RA, but previous guidance from the National Institute for Health and Care Excellence (NICE) has limited their use to patients with severely active disease. This has meant patients with moderately active RA have been treated as if they have an acceptable disease state, despite many cases where the inflammation has a major impact on joint damage, mobility, pain and quality of life. However, recent guideline changes (NICE TA715) have approved the use of three biologics - adalimumab, etanercept and infliximab - for the treatment of moderately active RA. Main body: In response to these changes, we have held discussions with medical teams from across the UK to consider the main implications for implementation of these new recommendations, as well as any differences in approach that may exist at a local level. Several key challenges were identified. These included establishing methods of educating both physicians and patients concerning the new availability of the biologic treatments, with suggestions of various organisations that could be approached to circulate informative material. Identifying which patients with moderately active RA stand to benefit was another discussion topic. Relying solely on scoring systems like Disease Activity Score in 28 Joints (DAS28) was acknowledged to have limitations, and alternative complementary approaches such as ultrasound, as well as assessing a patient's co-morbidities, could also be useful tools in determining those who could benefit from biologics. An additional challenge for the process of patient identification has been the increase in the use of telemedicine consultations in response to the coronavirus disease 2019 (COVID-19) pandemic. More use of patient-reported outcomes was raised as one possible solution, and the importance of maintaining up-to-date databases on patient disease scores and treatment history was also stressed. Conclusion: While challenges exist in education and identifying patients who may benefit from the use of biologics, the NICE TA715 recommendations hold great potential in addressing an unmet need for the treatment of moderate RA. Keywords: Biologics; Biosimilars; Moderate rheumatoid arthritis; National Institute for Health and Care Excellence (NICE); Telemedicine. © 2023. The Author(s). PubMed Disclaimer Conflict of interest statement PCT has received research grants from Galapagos and Consultation fees from AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, Nordic Pharma, Fresenius and UCB. EC has received research grants and served as a member of advisory boards and speaker bureaus of Abbvie, Allergan, Amgen, AstraZeneca, Bio-Cancer, Biocon, Biogen, BMS, Boehringer Ingelheim, Celgene, Chugai Pharma, Daiichi Sankyo, Eli Lilly, Fresenius Kabi, Ferring Pharmaceutical, Galapagos, Gilead, GSK, Hospira, ISIS, Jazz Pharmaceuticals, Janssen, MedImmune, Merck Serono, Merrimack Pharmaceutical, MSD, Napp, Novimmune, Novartis, ObsEva, Pfizer, Regeneron, Roche, R-Pharm, Sanofi, SynAct Pharma, Synovate, Tonix and UCB. MRE has received consultation fees from GlaxoSmithKline, Galapagos, Fresenius and AstraZeneca. SE has served as a member of advisory boards and received support (including attendance at conferences, speaker fees and honoraria) from Abbvie, Biogen, BMS, Celgene, Fresenius Kabi, Grifols, Janssen, MSD, Novartis, Roche and UCB. MKN undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis, Fresenius Kabi, Lilly, Galapagos, Nordic Pharma and UCB. Figures Fig. 1 Fig. 1 Summary of the main challenges… Similar articles A systematic review of the effectiveness of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis in adults and an economic evaluation of their cost-effectiveness. Chen YF, Jobanputra P, Barton P, Jowett S, Bryan S, Clark W, Fry-Smith A, Burls A. Health Technol Assess. 2006 Nov;10(42):iii-iv, xi-xiii, 1-229. doi: 10.3310/hta10420. PMID: 17049139 Review. Real-world Effectiveness of Biologic Disease-modifying Antirheumatic Drugs for the Treatment of Rheumatoid Arthritis After Etanercept Discontinuation in the United Kingdom, France, and Germany. Li N, Betts KA, Messali AJ, Skup M, Garg V. Clin Ther. 2017 Aug;39(8):1618-1627. doi: 10.1016/j.clinthera.2017.06.009. Epub 2017 Jul 17. PMID: 28729087 Associations between an expanded autoantibody profile and treatment responses to biologic therapies in patients with rheumatoid arthritis. Petro AD, Dougherty J, England BR, Sayles H, Duryee MJ, Hunter CD, Kremer JM, Pappas DA, Robinson WH, Curtis JR, Thiele GM, Mikuls TR. Int Immunopharmacol. 2021 Feb;91:107260. doi: 10.1016/j.intimp.2020.107260. Epub 2020 Dec 23. PMID: 33360371 Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis: a systematic review and economic evaluation. Rodgers M, Epstein D, Bojke L, Yang H, Craig D, Fonseca T, Myers L, Bruce I, Chalmers R, Bujkiewicz S, Lai M, Cooper N, Abrams K, Spiegelhalter D, Sutton A, Sculpher M, Woolacott N. Health Technol Assess. 2011 Feb;15(10):i-xxi, 1-329. doi: 10.3310/hta15100. PMID: 21333232 Free PMC article. Review. Delineation of the distinct inflammatory signaling roles of TAK1 and JAK1/3 in the CIA model of rheumatoid arthritis. Freeze R, Yang KW, Haystead T, Hughes P, Scarneo S. Pharmacol Res Perspect. 2023 Aug;11(4):e01124. doi: 10.1002/prp2.1124. PMID: 37564034 Free PMC article. See all similar articles Cited by Charting the Etanercept Journey: Tracing Cost Dynamics in Poland's Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly. Stajszczyk M, Batko K, Żuber ZM, Kwiatkowska B, Krajewska-Włodarczyk M, Batko B. BioDrugs. 2024 Jul;38(4):557-569. doi: 10.1007/s40259-024-00663-4. Epub 2024 Jun 11. PMID: 38861154 Free PMC article. References Taylor PC, Woods M, Rycroft C, Patel P, Blanthorn-Hazell S, Kent T, Bukhari M. Target literature review of current treatments and unmet need in moderate rheumatoid arthritis in the United Kingdom. Rheumatology (Oxford). 2021;60:4972–4981. doi: 10.1093/rheumatology/keab464. - DOI - PMC - PubMed Martin CR, Preedy VR. Scientific basis of healthcare: arthritis. Boca Raton, Florida, US: Taylor & Francis; 2012. Nikiphorou E, Jacklin H, Bosworth A, Jacklin C, Kiely P. Disease impact of rheumatoid arthritis in patients not treated with advanced therapies; survey findings from the National Rheumatoid Arthritis Society. Rheumatol Adv Pract. 2021;0:1–9. - PMC - PubMed Radner H, Smolen JS, Aletaha D. Remission in rheumatoid arthritis: benefit over low disease activity in patient-reported outcomes and costs. Arthritis Res Ther. 2014;16:R56. doi: 10.1186/ar4491. - DOI - PMC - PubMed Nikiphorou E, Norton S, Young A, Carpenter L, Dixey J, Walsh DA, Kiely P. Association between rheumatoid arthritis disease activity, progression of functional limitation and long-term risk of orthopaedic surgery: combined analysis of two prospective cohorts supports EULAR treat to target DAS thresholds. Ann Rheum Dis. 2016;75:2080–2086. doi: 10.1136/annrheumdis-2015-208669. - DOI - PMC - PubMed Show all 48 references Publication types Research Support, Non-U.S. Gov't MeSH terms Antirheumatic Agents* / therapeutic use Arthritis, Rheumatoid* / drug therapy Biological Products* / therapeutic use COVID-19* Humans Quality of Life Tumor Necrosis Factor Inhibitors / therapeutic use Substances Antirheumatic Agents Tumor Necrosis Factor Inhibitors Biological Products Related information MedGen LinkOut - more resources Full Text Sources BioMed Central Europe PubMed Central PubMed Central Medical MedlinePlus Health InformationItem Relapse after cessation of weekly tocilizumab for giant cell arteritis: a multicentre service evaluation in England(2023)Abstract Objectives The National Health Service in England funds 12 months of weekly s.c. tocilizumab (qwTCZ) for patients with relapsing or refractory GCA. During the coronavirus disease 2019 (COVID-19) pandemic, some patients were allowed longer treatment. We sought to describe what happened to patients after cessation of qwTCZ. Methods Multicentre service evaluation of relapse after stopping qwTCZ for GCA. The log-rank test was used to identify significant differences in time to relapse. Results A total of 336 GCA patients were analysed from 40 centres, treated with qwTCZ for a median [interquartile range (IQR)] of 12 (12–17) months. At time of stopping qwTCZ, median (IQR) prednisolone dose was 2 (0–5) mg/day. By 6, 12 and 24 months after stopping qwTCZ, 21.4%, 35.4% and 48.6%, respectively, had relapsed, requiring an increase in prednisolone dose to a median (IQR) of 20 (10–40) mg/day. 33.6% relapsers had a major relapse as defined by EULAR. Time to relapse was shorter in those that had previously also relapsed during qwTCZ treatment (P = 0.0017), in those not in remission at qwTCZ cessation (P = 0.0036) and in those with large vessel involvement on imaging (P = 0.0296). Age ≥65 years, gender, GCA-related sight loss, qwTCZ treatment duration, TCZ taper, prednisolone dosing and conventional synthetic DMARD use were not associated with time to relapse. Conclusion Up to half our patients with GCA relapsed after stopping qwTCZ, often requiring a substantial increase in prednisolone dose. One-third of relapsers had a major relapse. Extended use of TCZ or repeat treatment for relapse should be considered for these patients. Graphical Abstract Graphical Abstract Open in new tabDownload slide giant cell arteritis, vasculitis, tocilizumab, NICE guidance, service evaluation, relapse Topic: giant cell arteritisfollow-upprednisolonediagnostic imagingpandemicstocilizumabdisease remissionlarge blood vesselsnational health service (uk) Issue Section: Concise Report © The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/pages/standard-publication-reuse-rights)Item OP0178-HPR YOU FIRST: A COST-EFFECTIVE NURSE-LED PATIENT SUPPORT PROGRAMME – RETROSPECTIVE ANALYSIS FROM A LARGE MULTI-ETHNIC SETTING(2023)Abstract Background The global impact of COVID-19 on elective rheumatology services is unprecedented, [1,2] and the number of people on waiting lists for consultant-led elective care in the UK has almost doubled. [3] Implementation of patient support programmes that provide an individualised nurse-led service, such as You First, may help to reduce the strain on healthcare resources. You First is aimed at people who have been prescribed secukinumab, an injectable anti-interleukin 17A monoclonal antibody, for approved indications including psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis. Objectives This retrospective analysis aimed to evaluate the benefits of the You First patient support programme on the Rheumatology service at a large university teaching hospital with a catchment population of 350,000, of whom 40% are from ethnic minorities. Methods The analysis included adult participants who were eligible for treatment with secukinumab according to National Institute for Health and Care Excellence criteria and were enrolled in the You First programme. All You First nurses were registered with the Nursing, and Midwifery Council and underwent specific training, competency assessment and validation to ensure they met all regulatory clinical standards of National Health service (NHS) practice. Each participant was assigned to a dedicated nurse who visited the participant’s home to provide routine clinical assessments, routine follow-up visits, phlebotomy service, psychological support visits, injection training and routine secukinumab administration, as required. Participants could also schedule regular nurse telephone calls to discuss any disease or drug related concerns such as secukinumab dosing/adherence check and side effect management. All data gathered during the home visits and telephone calls were reported to the treating physicians. Calculation of cost savings was based on the number of visits carried out as part of You First and the cost that the NHS would have incurred if the visit occurred at the hospital (£2.02 for phlebotomy service, £24 for telephone contact, and £99 for each assessment, routine follow-up visits and psychological support visit). Here we present annualised data from 28 February 2019 to 14 July 2022. Results In total, 126 participants with PsA (n=81) and AS (n=45) were observed for 17.2 months on average. At baseline, the mean age was 52.7 years and 39.2% of participants were male. During the timeframe of this analysis, You First nurses had 1160 contact points with the clinical team (793 visits; 367 telephone calls). The median (interquartile range) number of visits and telephone calls carried out as part of the programme per participant per year was 6.4 (4.6–11.3): phlebotomy service 0.4 (0.0–1.6), clinical assessments 1.4 (0.0–2.0), routine follow-up visit 1.6 (0.7–3.1), psychological support visit 0.0 (0.0–0.0) and telephone contact 2.0 (1.0–4.7). This translated to an annual cost saving of £64,156.49 (phlebotomy service £335.90, clinical assessments £15,159.13, routine follow-up visits £36,434.58, psychological support visit £368.90, telephone contact £11,857.99). Conclusion Implementation of You First at this large university teaching hospital yielded substantial cost savings for the NHS, with outsourced visits providing the most cost savings. You First allowed people with PsA or AS to be managed at home, freeing NHS capacity for appointments with new and complex patients in the clinic. References [1]Akintayo RO, et al. Rheumatology (Oxford) 2021;60:392-398 [2]Machado PM, et al. Rheumatology Advances in Practice 2023;7:rkac108 [3]BMA. NHS backlog data analysis. Available at: https://www.bma.org.uk/advice-and-support/nhs-delivery-and-workforce/pressures/nhs-backlog-data-analysis Accessed 6th January 2023. Acknowledgements Medical writing support was provided by Anna Wydra, MSc, of OPEN Health Communications (London, UK) and funded by Novartis. Disclosure of Interests Muhammad Nisar Speakers bureau: MKN has received speaker fees from Novartis, Grant/research support from: MKN has received educational grants from Novartis, Julie Begum Speakers bureau: JB has received speaker fees from Novartis, Grant/research support from: JB has received educational grants from Novartis. https://doi.org/10.1136/annrheumdis-2023-eular.3784 Request Permissions If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.Item AB0881 CLINICAL TRAJECTORIES OF MULTIFACTORIAL HAND FUNCTION DETERIORATION IN SYSTEMIC SCLEROSIS(2023)Abstract Background Hand function deterioration is a major multifactorial driver of disability in Systemic Sclerosis (SSc) whose rate has been poorly described. Objectives The aim of this study is to describe incidence and risk factors of hand functional worsening in a longitudinal, multicenter, observational SSc cohort. Methods Hand involvement and disability were evaluated in consecutively enrolled patients for 24 months. Patient-reported hand impairment was captured with Cochin Hand Disability Score (CHFS) and the corresponding minimal clinical important differences (MCID) and patient acceptable symptom state (PASS). Clinical association with CHFS change over time and clinically meaningful worsening (MCID-Worsening) were investigated. Results Three-hundred-ninety-six patients from 10 centres were evaluated and 201 SSc (age 55.7±12.2 years, male 13.4%) were included in the final analysis. Median (IQR) disease duration was 5 (2-11) years while the proportion of patients with diffuse cutaneous variant was the 29.9%. Fifty-six (27.8%) patients had a CHFS ≥PASS at baseline. CHFS increased over time 35.8% of patients reaching CHFS≥PASS (p<0.001), and 52.2% of patients reporting MCID-Worsening at 24 months. A LASSO model simultaneously exploring the effects of multiple baseline clinical variables showed that MCID-Worsening was associated with male gender, LeRoy diffuse variant, late capillaroscopy pattern, shorter disease duration, absence of digital ulcers, presence of tenosynovitis, pain, Raynaud’s phenomenon, and global and hand disability severity, together with treatment with immunosuppressants, vasoactive medications, and second-line analgesics. Conclusion Hand function tends to deteriorate over time in one SSc patient in two despite available therapies and clinical assessment support risk stratification. These results pave the way to inform design of intervention studies aimed at improving the outcome of this major driver of disability in SSc. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests None Declared. https://doi.org/10.1136/annrheumdis-2023-eular.4720Item POS1200-HPR IL-17 OR TNF INHIBITORS - REAL WORLD IMPACT OF SHARED DECISION MAKING IN A NURSE LED BIOLOGICS SERVICE(2023)Abstract Background Since the availability of anti TNF biosimilars and the push from reimbursement panels to use them first line, real world data regarding therapeutic choice in biologic naive population is sparse. Objectives Evaluate the reasons for nurse led service choosing IL17 antagonists in biologic naïve SpA patients, in a shared decision making model, despite the availability of cheaper anti TNF biosimilar. Methods We conducted a retrospective analysis of our electronic register for people with PsA and AS from 1994 up to and including April 2022 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management. All patients were evaluated in biologics service led by clinical specialist nurses. Results PsA. 90 patients were prescribed Secukinumab since its availability in the UK. Mean age was 51 yrs (24-80) and 56 (62%) were women. All were prescribed since the adoption of Adalimumab biosimilar. Median duration of therapy was 551 days (62-1284). Mean TJC and SJC were 8.14 (1-64) and 3.15 (1-57) at initiation which improved at six months to 6.28 (1-46) and 2.77 (1-18) respectively. 24 (27%) were biologic naïve; 18 had it for better efficacy (six had axial disease, four with enthesitis and eight with concomitant moderate to severe psoriasis) and six for relative anti TNF contraindications including three with treated solid organ neoplasms, one with BMI>35 and two for concurrent chronic infections including HIV. AS. 47 patients were prescribed Secukinumab. Mean age was 54 (27-79) and half were women. Median duration of therapy was 679 days (51-1154). Mean BASDAI was 3.3 (0-9.2) at initiation which improved to 2.1 (0-7.5). 11 (23%) were biologic naïve; five had it for better efficacy and six for relative anti TNF contraindications including three with treated cancers, two with latent TB and one for MS. Conclusion To our knowledge this is the first dedicated retrospective review of a large real world spondyloarthritis cohort evaluating reasons for biologic choice. Nearly a quarter of patients were prescribed Secukinumab prior to cheaper adalimumab biosimilar despite it being commissioned first choice agent in the region. Clinicians including nurse specialists chose it for better efficacy in various SpA domains. Relative contraindication to anti TNF drugs, which would not have been considered significant in the past, was the second reason. Efficacy and safety outcomes were comparable to other biologics. This confirms that shared decision making process demands flexibility and limiting choice goes against clinical acumen and patient preference. Opting only for lower drug acquisition tariff is unlikely to be cost effective as the disease progresses whilst patients struggle with inappropriate prescription and thus delay biologics which are more likely to be efficacious and retained longer. Hence there is an urgent need to review prescribing guidelines to allow earlier employment of appropriate advanced therapies in the treatment paradigm with significant benefits to both patients and the health economy. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests Julie Begum: None declared, Muhammad Nisar Speakers bureau: Novarti.s. https://doi.org/10.1136/annrheumdis-2023-eular.920 Request Permissions If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
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