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American College of Rheumatology and Food and Drug Administration Summit: Summary of the Meeting May 17-18, 2022.

Kay, J ; Nikolov, NP ; et al.
In: Arthritis & rheumatology (Hoboken, N.J.), 2024-04-15
Online academicJournal

Titel:
American College of Rheumatology and Food and Drug Administration Summit: Summary of the Meeting May 17-18, 2022.
Autor/in / Beteiligte Person: Kay, J ; Nikolov, NP ; Weisman, MH
Link:
Zeitschrift: Arthritis & rheumatology (Hoboken, N.J.), 2024-04-15
Veröffentlichung: Ahead of Print, 2024
Medientyp: academicJournal
ISSN: 2326-5205 (electronic)
DOI: 10.1002/art.42864
Sonstiges:
  • Nachgewiesen in: MEDLINE
  • Sprachen: English
  • Corporate Authors: American College of Rheumatology Committee on Research
  • Publication Type: Journal Article
  • Language: English
  • [Arthritis Rheumatol] 2024 Apr 15. <i>Date of Electronic Publication: </i>2024 Apr 15.
  • References: American College of Rheumatology Rheumatoid Arthritis Clinical Trial Investigators Ad Hoc Task Force. American College of Rheumatology Clinical Trial Priorities and Design Conference, July 22–23, 2010. Arthritis Rheum 2011;63(8):2151–2156. ; US Food and Drug Administration. Guidance for industry. Rheumatoid arthritis: developing drug products for treatment. Draft Guidance. May 2013. Accessed March 28, 2024. https://www.fda.gov/media/86066/download. ; US Food and Drug Administration. Guidance for industry. Premarketing risk assessment. March 2005. Accessed March 28, 2024. https://www.fda.gov/media/71650/download. ; Tuyl F, Gerlach R, Mengersen K. The rule of three, its variants and extensions. Int Stat Rev 2009;77(2):266–275. ; US Food and Drug Administration. Real‐world evidence. February 5, 2023. Accessed March 4, 2024. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence. ; Raman SR, Curtis LH, Temple R, et al. Leveraging electronic health records for clinical research. Am Heart J 2018;202:13–19. ; Lin KJ, Singer DE, Glynn RJ, et al. Identifying patients with high data completeness to improve validity of comparative effectiveness research in electronic health records data. Clin Pharmacol Ther 2018;103(5):899–905. ; Madden JM, Lakoma MD, Rusinak D, et al. Missing clinical and behavioral health data in a large electronic health record (EHR) system. J Am Med Inform Assoc 2016;23(6):1143–1149. ; Casey A, Davidson E, Grover C, et al. Understanding the performance and reliability of NLP tools: a comparison of four NLP tools predicting stroke phenotypes in radiology reports. Front Digit Health 2023;5:1184919. ; Sauer BC, Teng CC, Accortt NA, et al. Models solely using claims‐based administrative data are poor predictors of rheumatoid arthritis disease activity. Arthritis Res Ther 2017;19(1):86. ; Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2021;73(7):924–939. ; Sentinel Initiative. Tofacitinib, disease‐modifying anti‐rheumatic drugs (DMARDs) and tumor necrosis factor inhibitors (TNFi) use: a descriptive analysis. February 24, 2022. Accessed March 4, 2024. https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/tofacitinib-disease-modifying-anti-rheumatic-drugs-dmards. ; US Food and Drug Administration. Guidance for industry and FDA staff. Best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data. 2013. Accessed March 4, 2024. https://www.fda.gov/media/79922/download. ; Kopp TI, Delcoigne B, Arkema EV, et al. Risk of neuroinflammatory events in arthritis patients treated with tumour necrosis factor alpha inhibitors: a collaborative population‐based cohort study from Denmark and Sweden. Ann Rheum Dis 2020;79(5):566–572. ; Zink A, Askling J, Dixon WG, et al. European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis 2009;68(8):1240–1246. ; Dennison EM, Packham J, Hyrich K. The BSRBR‐RA at 15 years. Rheumatology (Oxford) 2016;55(12):2093–2095. ; Zink A, Listing J, Kary S, et al. Treatment continuation in patients receiving biological agents or conventional DMARD therapy. Ann Rheum Dis 2005;64(9):1274–1279. ; Hetland ML. DANBIO−powerful research database and electronic patient record. Rheumatology (Oxford) 2011;50(1):69–77. ; Eriksson JK, Askling J, Arkema EV. The Swedish Rheumatology Quality Register: optimisation of rheumatic disease assessments using register‐enriched data. Clin Exp Rheumatol 2014;32(5 suppl 85):S‐147–S‐149. ; Hemminki K, Li X, Sundquist J, et al. Risk for multiple sclerosis in relatives and spouses of patients diagnosed with autoimmune and related conditions. Neurogenetics 2009;10(1):5–11. ; Raaschou P, Söderling J, Turesson C, et al; ARTIS Study Group. Tumor necrosis factor inhibitors and cancer recurrence in Swedish patients with rheumatoid arthritis: a nationwide population‐based cohort study. Ann Intern Med 2018;169(5):291–299. ; van Vollenhoven RF, Geborek P, Forslind K, et al; Swefot study group. Conventional combination treatment versus biological treatment in methotrexate‐refractory early rheumatoid arthritis: 2 year follow‐up of the randomised, non‐blinded, parallel‐group Swefot trial. Lancet 2012;379(9827):1712–1720. ; Miller H, Wallman JK, Petersson IF, et al. Mortality over 14 years in MTX‐refractory patients randomized to a strategy of addition of infliximab or sulfasalazine and hydroxychloroquine. Rheumatology (Oxford) 2021;60(5):2217–2222. ; Kremer JM. The CORRONA database. Autoimmun Rev 2006;5(1):46–54. ; Yazdany J, Robbins M, Schmajuk G, et al. Development of the American College of Rheumatology's rheumatoid arthritis electronic clinical quality measures. Arthritis Care Res (Hoboken) 2016;68(11):1579–1590. ; Mack ME, Hsia E, Aletaha D. Comparative assessment of the different American College of Rheumatology/European League Against Rheumatism remission definitions for rheumatoid arthritis for their use as clinical trial end points. Arthritis Rheumatol 2017;69(3):518–528. ; Felson DT, Smolen JS, Wells G, et al; American College of Rheumatology; European League Against Rheumatism. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum 2011;63(3):573–586. ; Felson DT, Lacaille D, LaValley MP, et al. Reexamining remission definitions in rheumatoid arthritis: considering the twenty‐eight‐joint disease activity score, c‐reactive protein level, and patient global assessment. Arthritis Rheumatol 2022;74(1):5–9. ; Studenic P, Felson D, de Wit M, et al. Testing different thresholds for patient global assessment in defining remission for rheumatoid arthritis: are the current ACR/EULAR Boolean criteria optimal? Ann Rheum Dis 2020;79(4):445–452. ; Studenic P, Aletaha D, de Wit M, et al. American College of Rheumatology/EULAR remission criteria for rheumatoid arthritis: 2022 revision. Arthritis Rheumatol 2023;75(1):15–22. ; Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38(6):727–735. ; Kerschbaumer A, Smolen JS, Herkner H, et al. Efficacy outcomes in phase 2 and phase 3 randomized controlled trials in rheumatology. Nat Med 2020;26(6):974–980. ; Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999;28;340(4):253–259. ; Capelusnik D, Aletaha D. Baseline predictors of different types of treatment success in rheumatoid arthritis. Ann Rheum Dis 2022;81(2):153–158. ; FitzGerald O, Ogdie A, Chandran V, et al. Psoriatic arthritis. Nat Rev Dis Primers 2021;7(1):59. ; Mease PJ. Measures of psoriatic arthritis: tender and swollen joint assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken) 2011;63(suppl 11):S64–S85. ; Aouad K, Moysidou G, Rakotozafiarison A, et al. Outcome measures used in psoriatic arthritis registries and cohorts: a systematic literature review of 27 registries or 16,183 patients. Semin Arthritis Rheum 2021;51(4):888–894. ; Coates LC, FitzGerald O, Gladman DD, et al. Reduced joint counts misclassify patients with oligoarticular psoriatic arthritis and miss significant numbers of patients with active disease. Arthritis Rheum 2013;65(6):1504–1509. ; Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis 2010;69(1):48–53. ; Ogdie A, Coates L. The changing face of clinical trials in psoriatic arthritis. Curr Rheumatol Rep 2017;19(4):21. ; Fredriksson T, Pettersson U. Severe psoriasis‐‐oral therapy with a new retinoid. Dermatologica 1978;157(4):238–44. doi:10.1159/000250839. ; Lillegraven S, van der Heijde D, Uhlig T, et al. What is the clinical relevance of erosions and joint space narrowing in RA? Nat Rev Rheumatol 2012;8(2):117–120. ; Strand V, Kingsbury SR, Woodworth T, et al. OMERACT 10 Sharp Symposium: important findings in examination of imaging methods for measurement of joint damage in rheumatoid arthritis. J Rheumatol 2011;38(9):2009–2013. ; American College of Rheumatology Rheumatoid Arthritis Clinical Trials Task Force Imaging Group and Outcome Measures in Rheumatology Magnetic Resonance Imaging Inflammatory Arthritis Working Group. The utility of magnetic resonance imaging for assessing structural damage in randomized controlled trials in rheumatoid arthritis. Arthritis Rheum 2013;65(10):2513–2523. ; Hetland ML, Ejbjerg B, Hørslev‐Petersen K, et al; CIMESTRA study group. MRI bone oedema is the strongest predictor of subsequent radiographic progression in early rheumatoid arthritis. Results from a 2‐year randomised controlled trial (CIMESTRA). Ann Rheum Dis 2009;68(3):384–390. ; Emery P, van der Heijde D, Ostergaard M, et al. Exploratory analyses of the association of MRI with clinical, laboratory and radiographic findings in patients with rheumatoid arthritis. Ann Rheum Dis 2011;70(12):2126–2130. ; Peterfy C, Emery P, Tak PP, et al. MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo‐controlled, double‐blind RA‐SCORE study. Ann Rheum Dis 2016;75(1):170–177. ; Conaghan PG, Østergaard M, Bowes MA, et al. Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate‐naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques. Ann Rheum Dis 2016;75(6):1024–1033. ; D'Agostino MA, Wakefield RJ, Berner‐Hammer H, et al; OMERACT‐EULAR‐Ultrasound Task Force. Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study. Ann Rheum Dis 2016;75(10):1763–1769. ; D'Agostino MA, Schett G, López‐Rdz A, et al. Response to secukinumab on synovitis using power Doppler ultrasound in psoriatic arthritis: 12‐week results from a phase III study, ULTIMATE. Rheumatology (Oxford) 2022;61(5):1867–1876. ; Østergaard M, Bird P, Pachai C, et al. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford) 2022;61(11):4305–4313. ; Krabbe S, Østergaard M, Eshed I, et al. Whole‐body magnetic resonance imaging in axial spondyloarthritis: reduction of sacroiliac, spinal, and entheseal inflammation in a placebo‐controlled trial of adalimumab. J Rheumatol 2018;45(5):621–629. ; Boers M. A new design for registration trials in rheumatoid arthritis allowing secondary head‐to‐head comparisons with standard of care treatment including biologicals. Ann Rheum Dis 2010;69(1):4–6. ; US Food and Drug Administration. Non‐inferiority clinical trials to establish effectiveness. Guidance for Industry. 2016. Accessed March 4. 2024. https://www.fda.gov/media/78504/download. ; Ghiti Moghadam M, Vonkeman HE, Ten Klooster PM, et al; Dutch National POET Collaboration. Stopping tumor necrosis factor inhibitor treatment in patients with established rheumatoid arthritis in remission or with stable low disease activity: a pragmatic multicenter, open‐label randomized controlled trial. Arthritis Rheumatol 2016;68(8):1810–1817. ; The National Patient‐Centered Clinical Research Network (PCORnet). Accessed March 28, 2024. https://pcornet.org/data/. ; US Food and Drug Administration. Complex innovative trial design meeting program. October 3, 2023. Accessed March 28, 2024. https://www.fda.gov/drugs/development-resources/complex-innovative-trial-design-meeting-program. ; Deane KD, Holers VM. Rheumatoid arthritis pathogenesis, prediction, and prevention: an emerging paradigm shift. Arthritis Rheumatol 2021;73(2):181–193. ; Bos WH, Dijkmans BA, Boers M, et al. Effect of dexamethasone on autoantibody levels and arthritis development in patients with arthralgia: a randomised trial. Ann Rheum Dis 2010;69(3):571–574. ; Cope AP, Jasenecova M, Vasconcelos JC, et al; APIPPRA study investigators. Abatacept in individuals at high risk of rheumatoid arthritis (APIPPRA): a randomised, double‐blind, multicentre, parallel, placebo‐controlled, phase 2b clinical trial. Lancet 2024;403(10429):838–849. ; Deane K, Striebich C, Feser M, et al. Hydroxychloroquine does not prevent the future development of rheumatoid arthritis in a population with baseline high levels of antibodies to citrullinated protein antigens and absence of inflammatory arthritis: interim analysis of the StopRA trial [abstract]. Arthritis Rheumatol 2022;74(suppl 9). https://acrabstracts.org/abstract/hydroxychloroquine‐does‐not‐prevent‐the‐future‐development‐of‐rheumatoid‐arthritis‐in‐a‐population‐with‐baseline‐high‐levels‐of‐antibodies‐to‐citrullinated‐protein‐antigens‐and‐absence‐of‐inflammatory/. ; Gerlag DM, Safy M, Maijer KI, et al. Effects of B‐cell directed therapy on the preclinical stage of rheumatoid arthritis: the PRAIRI study. Ann Rheum Dis 2019;78(2):179–185. ; Rech J, Tascilar K, Hagen M, et al. Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): a randomised, international, multicentre, double‐blind, placebo‐controlled trial. Lancet 2024;403(10429):850–859. ; van Boheemen L, Turk S, Beers‐Tas MV, et al. Atorvastatin is unlikely to prevent rheumatoid arthritis in high risk individuals: results from the prematurely stopped STAtins to Prevent Rheumatoid Arthritis (STAPRA) trial. RMD Open 2021;7(1):e001591. ; Mankia K, Siddle HJ, Kerschbaumer A, et al. EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis. Ann Rheum Dis 2021;80(10):1286–1298. ; Herold KC, Bundy BN, Long SA, et al. An anti‐CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med 2019;381(7):603–613. ; van Steenbergen HW, Cope AP, van der Helm‐van Mil AHM. Rheumatoid arthritis prevention in arthralgia: fantasy or reality? Nat Rev Rheumatol 2023;19(12):767–777. ; US Food and Drug Administration. Digital health technologies for remote data acquisition in clinical investigations. Guidance for industry, investigators, and other stakeholders. December 2023. Accessed March 4. 2024. https://www.fda.gov/media/155022/download. ; US Food and Drug Administration. Considerations for the use of real‐world data and real‐world evidence to support regulatory decision‐making for drug and biological products. Guidance for industry. August 2023. Accessed March 28, 2024. https://www.fda.gov/media/171667/download.
  • Entry Date(s): Date Created: 20240415 Latest Revision: 20240528
  • Update Code: 20240529

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