https://doi.org/10.4081/reumatismo.2022.1528
The data project: a shared approach between stakeholders of the healthcare system in definition of a therapeutic algorithm for inflammatory arthritis
Submitted: 25 September 2022
Accepted: 5 December 2022
Published: 21 March 2023
Accepted: 5 December 2022
Abstract Views: 635
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Rheumatic musculoskeletal diseases or RMD [rheumatoid arthritis (RA) and spondyloarthritis (SpA)] are systemic inflammatory diseases for which there are no biomarkers capable of predicting treatments with a higher likelihood of response in naive patients. In addition, the expiration of the anti-TNF blocking drugs’ patents has resulted in the availability of anti-TNF biosimilar drugs with the same efficacy and safety than originators but at significantly reduced prices. To guarantee a personalized therapeutic approach to RMD treatment, a board of rheumatologists and stakeholders from the Campania region, Italy, developed a clinically applicable arthritis therapeutic algorithm to guide rheumatologists (DATA project). The general methodology relied on a Delphi technique forecast to produce a set of statements that summarized the experts’ consensus. Selected clinical scenarios were discussed in light of the available evidence, and there were two rounds of voting on the therapeutic approaches. Separate discussions were held regarding rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The decision-making factors for each disease were clinical presentation, demographics, and comorbidities. In this paper, we describe a virtuous process between rheumatologists and healthcare system stakeholders that resulted in the development of a shared therapeutic algorithm for RMD patients naive to bDMARDs.
Kim JH, Choi IA. Cardiovascular morbidity and mortality in patients with spondyloarthritis: A meta-analysis. Int J Rheum Dis. 2021; 24: 477-86.
DOI: https://doi.org/10.1111/1756-185X.13970
Provan SA, Lillegraven S, Sexton J, et al. Trends in all-cause and cardiovascular mortality in patients with incident rheumatoid arthritis: A 20-year follow-up matched case-cohort study. Rheumatol (United Kingdom). 2020; 59: 505-12.
DOI: https://doi.org/10.1093/rheumatology/kez371
Giacomelli R, Afeltra A, Bartoloni E, et al. The growing role of precision medicine for the treatment of autoimmune diseases; results of a systematic review of literature and Experts’ Consensus. Autoimmun Rev. 2021; 20.
DOI: https://doi.org/10.1016/j.autrev.2020.102738
Kay J. Overcoming barriers to biosimilars in inflammatory arthritis. Nat Rev Rheumatol. 2020; 16: 65-66.
DOI: https://doi.org/10.1038/s41584-019-0359-7
Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015; 44: S2-S8.
DOI: https://doi.org/10.1016/j.semarthrit.2015.04.002
Ottaviani S, Gardette A, Roy C, et al. Body mass index and response to rituximab in rheumatoid arthritis. Jt Bone Spine. 2015; 82: 432-6.
DOI: https://doi.org/10.1016/j.jbspin.2015.02.011
Gremese E, Carletto A, Padovan M, et al. Obesity and reduction of the response rate to antitumor necrosis factor α in rheumatoid arthritis: An approach to a personalized medicine. Arthritis Care Res. 2013; 65: 94-100.
DOI: https://doi.org/10.1002/acr.21768
Iannone F, Courvoisier DS, Gottenberg JE, et al. Body mass does not impact the clinical re-response to intravenous abatacept in patients with rheumatoid arthritis. Analysis from the ‘pan-European registry collaboration for abatacept (PANABA). Clin Rheumatol. 2017; 36: 773-9.
DOI: https://doi.org/10.1007/s10067-016-3505-5
Channual J, Wu JJ, Dann FJ. Effects of tumor necrosis factor-α blockade on metabolic syndrome components in psoriasis and psoriatic arthritis and additional lessons learned from rheumatoid arthritis. Dermatol Ther. 2009; 22: 61-73.
DOI: https://doi.org/10.1111/j.1529-8019.2008.01217.x
Costa L, Caso F, Atteno M, et al. Impact of 24-month treatment with etanercept, adalimumab, or methotrexate on metabolic syndrome components in a cohort of 210 psoriatic arthritis patients. Clin Rheumatol. 2014; 33: 833-9.
DOI: https://doi.org/10.1007/s10067-013-2369-1
Ruscitti P, Masedu F, Alvaro S, et al. Anti-in-terleukin-1 treatment in patients with rheumatoid arthritis and type 2 diabetes (TRACK): A multicentre, open-label, randomised controlled trial. PLoS Med. 2019; 16: 1-22.
DOI: https://doi.org/10.1371/journal.pmed.1002901
Cock D De, Hyrich K. Malignancy and rheumatoid arthritis: Epidemiology, risk factors and management. Best Pract Res Clin Rheumatol. 2018; 32: 869-86.
DOI: https://doi.org/10.1016/j.berh.2019.03.011
Wadström H, Frisell T, Askling J. Malignant neoplasms in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors, tocilizumab, abatacept, or rituximab in clinical practice: A nationwide cohort study from Sweden. JAMA Intern Med. 2017; 177: 1605-12.
DOI: https://doi.org/10.1001/jamainternmed.2017.4332
Atzeni F, Carletto A, Foti R, et al. Incidence of cancer in patients with spondyloarthritis treated with anti-TNF drugs. Jt Bone Spine. 2018; 85: 455-9.
DOI: https://doi.org/10.1016/j.jbspin.2017.08.003
Hellgren K, Dreyer L, Arkema EV, et al. Cancer risk in patients with spondyloarthritis treated with TNF inhibitors: A collaborative study from the ARTIS and DANBIO registers. Ann Rheum Dis. 2017; 76: 105-11.
DOI: https://doi.org/10.1136/annrheumdis-2016-209270
Fagerli KM, Kearsley-Fleet L, Mercer LK, et al. Malignancy and mortality rates in patients with severe psoriatic arthritis requiring tumour-necrosis factor alpha inhibition: results from the British Society for Rheumatology Biologics Register. Rheumatol (United Kingdom). 2019; 58: 80-5.
DOI: https://doi.org/10.1093/rheumatology/key241
Luo X, Deng C, Fei Y, et al. Malignancy development risk in psoriatic arthritis patients undergoing treatment: a systematic review and meta-analysis. Semin Arthritis Rheum. 2019; 48: 626-31.
DOI: https://doi.org/10.1016/j.semarthrit.2018.05.009
Hellgren K, Ballegaard C, Delcoigne B, et al. Risk of solid cancers overall and by subtypes in patients with psoriatic arthritis treated with TNF inhibitors - a Nordic cohort study. Rheumatology (Oxford). 2021; 60: 3656-68.
DOI: https://doi.org/10.1093/rheumatology/keaa828
Regierer AC, Strangfeld A. Rheumatoid arthritis treatment in patients with a history of cancer. Curr Opin Rheumatol. 2018; 30: 288-94.
DOI: https://doi.org/10.1097/BOR.0000000000000492
Doran MF, Crowson CS, Pond GR, O’Fallon WM, Gabriel SE. Predictors of infection in rheumatoid arthritis. Arthritis Rheum. 2002; 46: 2294-300.
DOI: https://doi.org/10.1002/art.10529
Lahiri M, Dixon WG. Risk of infection with biologic antirheumatic therapies in patients with rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2015; 29: 290-305.
DOI: https://doi.org/10.1016/j.berh.2015.05.009
Salliot C, Dougados M, Gossec L. Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: Meta-analyses of randomised placebo-controlled trials. Ann Rheum Dis. 2009; 68: 25-32.
DOI: https://doi.org/10.1136/ard.2007.083188
Chen SK, Liao KP, Liu J, Kim SC. Risk of hospitalized infection and initiation of abatacept versus tumor necrosis factor inhibitors among patients with rheumatoid arthritis: a propensity score-matched cohort study. Arthritis Care Res. 2020; 72: 9-17.
DOI: https://doi.org/10.1002/acr.23824
Minozzi S, Bonovas S, Lytras T, et al. Risk of infections using anti-TNF agents in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: a systematic review and meta-analysis. Expert Opin Drug Saf. 2016; 15: 11-34.
DOI: https://doi.org/10.1080/14740338.2016.1240783
Haddad A, Li S, Thavaneswaran A, Cook RJ, Chandran V, Gladman DD. The incidence and predictors of infection in psoriasis and psoriatic arthritis: results from longitudinal observational cohorts. J Rheumatol. 2016; 43: 362-6.
DOI: https://doi.org/10.3899/jrheum.140067
Zabotti A, Goletti D, Lubrano E, Cantini F. The impact of the interleukin 12/23 inhibitor ustekinumab on the risk of infections in patients with psoriatic arthritis. Expert Opin Drug Saf. 2020; 19: 69-82.
DOI: https://doi.org/10.1080/14740338.2020.1703946
Saunte DM, Mrowietz U, Puig L, Zachariae C. Candida infections in patients with psoriasis and psoriatic arthritis treated with interleukin-17 inhibitors and their practical management. Br J Dermatol. 2017; 177: 47-62.
DOI: https://doi.org/10.1111/bjd.15015
Tsuboi H, Matsumoto I, Hagiwara S, et al. Effectiveness of abatacept for patients with Sjögren’s syndrome associated with rheumatoid arthritis. An open label, multicenter, one-year, prospective study: ROSE (Rheumatoid Arthritis with Orencia Trial toward Sjögren’s syndrome Endocrinopathy) trial. Mod Rheumatol. 2016; 26: 891-9.
DOI: https://doi.org/10.3109/14397595.2016.1158773
Verstappen GM, Nimwegen JF van, Vissink A, Kroese FGM, Bootsma H. The value of rituximab treatment in primary Sjögren’s syndrome. Clin Immunol. 2017; 182: 62-71.
DOI: https://doi.org/10.1016/j.clim.2017.05.002
Sepriano A, Kerschbaumer A, Smolen JS, et al. Safety of synthetic and biological DMARDs: A systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2020; 79: S760-70.
DOI: https://doi.org/10.1136/annrheumdis-2019-216653
d’Alessandro M, Perillo F, Metella Refini R, et al. Efficacy of baricitinib in treating rheumatoid arthritis: Modulatory effects on fibrotic and inflammatory biomarkers in a real-life setting. Int Immunopharmacol. 2020; 86: 1-5.
DOI: https://doi.org/10.1016/j.intimp.2020.106748
Kurata I, Tsuboi H, Terasaki M, et al. Effect of biological disease-modifying anti-rheumatic drugs on airway and interstitial lung disease in patients with rheumatoid arthritis. Intern Med. 2019; 58: 1703-12.
DOI: https://doi.org/10.2169/internalmedicine.2226-18
Vadillo C, Nieto MA, Romero-Bueno F, et al. Efficacy of rituximab in slowing down progression of rheumatoid arthritis-related interstitial lung disease: Data from the NEREA Registry. Rheumatol (United Kingdom). 2020; 59: 2099-108.
DOI: https://doi.org/10.1093/rheumatology/kez673
Coates LC, Kavanaugh A, Mease PJ, et al. Group for research and assessment of psoriasis and psoriatic arthritis 2015 treatment recommendations for psoriatic arthritis. Arthritis Rheumatol. 2016; 68: 1060-71.
DOI: https://doi.org/10.1002/art.39573
Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020; 79: S700-12.
DOI: https://doi.org/10.1136/annrheumdis-2020-217163
Dreyer L, Magyari M, Laursen B, Cordtz R, Sellebjerg F, Locht H. Risk of multiple sclerosis during tumour necrosis factor inhibitor treatment for arthritis: A population-based study from DANBIO and the Danish Multiple Sclerosis Registry. Ann Rheum Dis. 2016; 75: 785-6.
DOI: https://doi.org/10.1136/annrheumdis-2015-208490
Clowse ME, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: Results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017; 76: 1890-6.
DOI: https://doi.org/10.1136/annrheumdis-2017-211384
Mariette X, Förger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: Results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018; 77: 228-33.
DOI: https://doi.org/10.1136/annrheumdis-2017-212196
Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020; 79: S685-99.
Lee YH, Song GG. Relative efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib in comparison to adalimumab in patients with active rheumatoid arthritis. Z Rheumatol. 2020; 79: 785-96.
DOI: https://doi.org/10.1007/s00393-020-00750-1
Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: Results from the double-blind, randomized, phase 3 MAXI- MISE trial. Ann Rheum Dis. 2021; 80: 582-90.
DOI: https://doi.org/10.1136/annrheumdis-2020-218808
Mourad A, Gniadecki R. Treatment of dactylitis and enthesitis in psoriatic arthritis with biologic agents: A systematic review and meta-analysis. J Rheumatol. 2020; 47: 59-65.
DOI: https://doi.org/10.3899/jrheum.180797
Araujo EG, Englbrecht M, Hoepken S, et al. Effects of ustekinumab versus tumor necrosis factor inhibition on enthesitis: Results from the enthesial clearance in psoriatic arthritis (ECLIPSA) study. Semin Arthritis Rheum. 2019; 48: 632-7.
DOI: https://doi.org/10.1016/j.semarthrit.2018.05.011
Mease PJ, Smolen JS, Behrens F, et al. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis 2020; 79: 123-31.
DOI: https://doi.org/10.1136/annrheumdis-2019-215386
McInnes IB, Behrens F, Mease PJ, et al. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet (London, England). 2020; 395: 1496-505.
DOI: https://doi.org/10.1016/S0140-6736(20)30564-X
Reich K, Sullivan J, Arenberger P, et al. Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial. Br J Dermatol. 2019; 181: 954-66.
DOI: https://doi.org/10.1111/bjd.17351
Wasel N, Thaçi D, French LE, et al. Ixekizumab and ustekinumab efficacy in nail psoriasis in patients with moderate-to-severe psoriasis: 52-week results from a phase 3, head-to-head study (IXORA-S). Dermatol Ther (Heidelb). 2020; 10: 663-70.
DOI: https://doi.org/10.1007/s13555-020-00383-x
Heijde D Van Der, Ramiro S, Landewé R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017; 76: 978-91.
DOI: https://doi.org/10.1136/annrheumdis-2016-210770
Braun J, Baraliakos X, Deodhar A, et al. Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study. Rheumatol (United Kingdom). 2019; 58: 859-68.
DOI: https://doi.org/10.1093/rheumatology/key375
Sari I, Haroon N. Disease modification in axial spondyloarthritis. Best Pract Res Clin Rheumatol. 2018; 32: 427-39.
DOI: https://doi.org/10.1016/j.berh.2019.02.007
How to Cite
Pantano, I., Mauro, D., Simone, D., Costa, L., Capocotta, D., Raimondo, M., Birra, D., Cuomo, G., D’Errico, T., Ferrucci, M., Comentale, F., Italiano, G., Moscato, P., Pappone, N., Russo, R., Scarpato, S., Tirri, R., Buono, P., Postiglione, A., Guida, R., Scarpa, R., Trama, U., Tirri, E., & Ciccia, F. (2023). The data project: a shared approach between stakeholders of the healthcare system in definition of a therapeutic algorithm for inflammatory arthritis. Reumatismo, 74(4). https://doi.org/10.4081/reumatismo.2022.1528
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