South African Rheumatism and Arthritis Association 2024 guidelines for the use of biologic and targeted synthetic disease-modifying antirheumatic drugs
DOI:
https://doi.org/10.7196/SAMJ.2024.v114i10.2599Keywords:
targeted synthetic therapy, biologic, South AfricaAbstract
Biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) target a specific pathway of the immune system, and are usually prescribed after failure of conventional synthetic disease-modifying antirheumatic drug therapy. The choice of b/tsDMARD depends on the disease profile and comorbidities, patient preference, registered indications of the drugs, and risks associated with therapy. It is recommended that b/tsDMARDs for immune-mediated inflammatory rheumatic diseases are prescribed by a rheumatologist, and all patients must be included in the South African Rheumatism and Arthritis Association biologic registry. Knowledge of and vigilance for adverse events, particularly infections, associated with b/ts DMARD therapies are of paramount importance.
References
Sepriano A, Kerschbaumer A, Bergstra SA, et al. Safety of synthetic and biological DMARDs: A systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2023;82(1):107-118. https://doi.org/10.1136/ ard-2022-223357
Vassilopoulos A, Shehadeh F, Benitez G, et al. The incidence of opportunistic infections in patients with psoriatic arthritis treated with biologic and targeted synthetic agents: A systematic review and meta-analysis. Front Pharmacol 2022;13:992713. https://doi.org/10.3389/fphar.2022.992713
Adas MA, Allen VB, Yates M, et al. A systematic review and network meta-analysis of the safety of early interventional treatments in rheumatoid arthritis. Rheumatology (Oxford) 2021;60(10):4450- 4462. https://doi.org/10.1093/rheumatology/keab429
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(6):760-770. https://doi.org/10.1136/ annrheumdis-2019-216653
World Health Organization. WHO global lists of high burden countries for tuberculosis (TB), TB/HIV and multidrug/rifampicin-resistant TB (MDR/RR-TB), 2021 - 2025: Background document. 2021. https://cdn.who.int/media/docs/default-source/hq-tuberculosis/who_globalhbcliststb_2021-2025_ backgrounddocument.pdf?sfvrsn=f6b854c2_9 (accessed 19 February 2024).
Goletti D, Petrone L, Ippolito G, Niccoli L, Nannini C, Cantini F. Preventive therapy for tuberculosis in rheumatological patients undergoing therapy with biological drugs. Exp Rev Anti Infect Ther 2018;16(6):501-512. https://doi.org/10.1080/14787210.2018.1483238
Zhou G, Luo Q, Luo S, et al. Interferon-γ release assays or tuberculin skin test for detection and management of latent tuberculosis infection: A systematic review and meta-analysis. Lancet Infect Dis 2020;20(12):1457-1469. https://doi.org/10.1016/S1473-3099(20)30276-0
Tseng S-Y, Huang Y-S, Chang T-E, Perng C-L, Huang Y-H. Hepatotoxicity, efficacy and completion rate between 3 months of isoniazid plus rifapentine and 9 months of isoniazid in treating latent tuberculosis infection: A systematic review and meta-analysis. J Chin Med Assoc 2021;84(11):993- 1000. https://doi.org/10.1097/JCMA.0000000000000605
Tikly M, Hodkinson B, Dheda K. Biologic therapy for rheumatoid arthritis in developing countries – a place for non-TNF inhibitors as first-line treatment? Rheumatology 2015;54(2):208-209. https://doi. org/10.1093/rheumatology/keu040
Hong X, Xiao Y, Xu L, Liu L, Mo H, Mo H. Risk of hepatitis B reactivation in HBsAg−/HBcAb+ patients after biologic or JAK inhibitor therapy for rheumatoid arthritis: A meta‐analysis. Immun Inflamm Dis 2023;11(2):e780. https://doi.org/10.1002/iid3.780
Winthrop KL, Tanaka Y, Lee EB, et al. Prevention and management of herpes zoster in patients with rheumatoid arthritis and psoriatic arthritis: A clinical review. Clin Exp Rheumatol 2022;40(1):162-172. https://doi.org/10.55563/clinexprheumatol/cpu6r9
Jansen MH, Rondaan C, Legger GE, et al. EULAR/PRES recommendations for vaccination of paediatric patients with autoimmune inflammatory rheumatic diseases: Update 2021. Ann Rheum Dis 2023;82(1):35-47. https://doi.org/10.1136/annrheumdis-2022-222574
Furer V, Rondaan C, Heijstek MW, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2020;79(1):39-52. https://doi.org/10.1136/annrheumdis-2019-215882
Feldman C, Dlamini S, Richards GA, et al. A comprehensive overview of pneumococcal vaccination recommendations for adults in South Africa, 2022. J Thoracic Dis 2022;14(10):4150-4172. https://doi. org/10.21037/jtd-22-287
Dagnew AF, Rausch D, Herve C, et al. Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: A pooled post hoc analysis on two parallel randomized trials. Rheumatology (Oxford) 2021;60(3):1226-1233. https://doi.org/10.1093/rheumatology/keaa424
Russell LA, Craig C, Flores EK, et al. Preoperative management of medications for rheumatologic and HIV diseases: Society for Perioperative Assessment and Quality Improvement (SPAQI) consensus statement. Mayo Clin Proc 2022;97(8):1551-1571. https://doi.org/10.1016/j.mayocp.2022.05.002
Komaki F, Komaki Y, Micic D, Ido A, Sakuraba A. Outcome of pregnancy and neonatal complications with anti-tumor necrosis factor-α use in females with immune mediated diseases: A systematic review and meta-analysis. J Autoimmun 2017;76:38-52. https://doi.org/10.1016/j.jaut.2016.11.004
Hoxha A, Calligaro A, di Poi E, et al. Pregnancy and foetal outcomes following anti-tumor necrosis factor alpha therapy: A prospective multicentre study. Joint Bone Spine 2017;84(2):169-173. https:// doi.org/10.1016/j.jbspin.2016.03.014
Russell MD, Dey M, Flint J, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology 2023;62(4):e48-e88. https://doi.org/10.1093/rheumatology/keac551
Skorpen CG, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis 2016;75(5):795-810. https://doi.org/10.1136/annrheumdis-2015-208840
Perrotta K, Kiernan E, Bandoli G, Manaster R, Chambers C. Pregnancy outcomes following maternal treatment with rituximab prior to or during pregnancy: A case series. Rheumatol Adv Pract 2021;5(1):rkaa074. https://doi.org/10.1093/rap/rkaa074
Das G, Damotte V, Gelfand JM, et al. Rituximab before and during pregnancy: A systematic review, and a case series in MS and NMOSD. Neurol Neuroimmunol Neuroinflamm 2018;5(3):e453. https:// doi.org/10.1212/NXI.0000000000000453
Emery P, Pope JE, Kruger K, et al. Efficacy of monotherapy with biologics and JAK inhibitors for the treatment of rheumatoid arthritis: A systematic review. Adv Ther 2018;35(10):1535-1563. https://doi. org/10.1007/s12325-018-0757-2
Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti‐tumor necrosis factor alpha monoclonal antibody combined with low‐dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998;41(9):1552-1563. https://doi.org/10.1002/1529- 0131(199809)41:9<1552::AID-ART5>3.0.CO;2-W
Smolen JS, Landewé RB, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis 2023;82(1):3-18. https://doi.org/10.1136/ard-2022-223356
Fagerli KM, Lie E, van der Heijde D, et al. The role of methotrexate co-medication in TNF-inhibitor treatment in patients with psoriatic arthritis: Results from 440 patients included in the NOR-DMARD study. Ann Rheum Dis 2014;73(1):132-137. https://doi.org/10.1136/annrheumdis-2012-202347
Mease PJ, Collier DH, Saunders KC, Li G, Kremer JM, Greenberg JD. Comparative effectiveness of biologic monotherapy versus combination therapy for patients with psoriatic arthritis: Results from the Corrona registry. RMD Open 2015;1(1):e000181. https://doi.org/10.1136/rmdopen-2015-000181
Mease PJ, Gladman DD, Collier DH, et al. Etanercept and methotrexate as monotherapy or in combination for psoriatic arthritis: Primary results from a randomised, controlled phase III trial. Arthritis Rheumatol 2019;71(7):1112-1124. https://doi.org/10.1002/art.40851
Smolen JS, Keystone E, Emery P, et al. Consensus statement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis 2007;66(2):143-150. https://doi.org/10.1136/ard.2006.061002
Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol 2016;68(1):1-26. https://doi.org/10.1002/ art.39480
Kim J-W, Jung J-Y, Suh C-H. Real-world observational study of biosimilars in inflammatory arthritis treatment: A systematic literature review. Expert Opin Biol Ther 2021;21(1):57-73. https://doi.org/10 .1080/14712598.2020.1812575
Herndon TM, Ausin C, Brahme NN, et al. Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis. PLoS ONE 2023;18(10):e0292231. https:// doi.org/10.1371/journal.pone.0292231
Tanaka E, Kawahito Y, Kohno M, et al. Systematic review and meta-analysis of biosimilar for the treatment of rheumatoid arthritis informing the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis. Mod Rheumatol 2022;32(1):74-86. https://doi.org/10.1080/14397595.2021.1899591
Smolen JS, Goncalves J, Quinn M, Benedetti F, Lee JY. Era of biosimilars in rheumatology: Reshaping the healthcare environment. RMD Open 2019;5(1):e000900. https://doi.org/10.1136/ rmdopen-2019-000900
Chiu YM, Lu YP, Lan JL, Chen DY, Wang JD. Lifetime risks, life expectancy, and health care expenditures for rheumatoid arthritis: A nationwide cohort followed up from 2003 to 2016. Arthritis Rheumatol 2021;73(5):750-758. https://doi.org/10.1002/art.41597
Birnbaum H, Pike C, Kaufman R, Maynchenko M, Kidolezi Y, Cifaldi M. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin 2010;26(1):77-90. https://doi. org/10.1185/03007990903422307
Bagepally BS, Kumar SS, Sasidharan A, Haridoss M, Venkataraman K. Household catastrophic health expenditures for rheumatoid arthritis: A single centre study from South India. Sci Rep 2023;13(1):15385. https://doi.org/10.1038/s41598-023-42623-y
Curtis JR, Fox KM, Xie F, et al. The economic benefit of remission for patients with rheumatoid arthritis. Rheumatol Ther 2022;9(5):1329-1345. https://doi.org/10.1007/s40744-022-00473-6
Benucci M, Saviola G, Manfredi M, Sarzi-Puttini P, Atzeni F. Cost effectiveness analysis of disease- modifying antirheumatic drugs in rheumatoid arthritis. A systematic review literature. Int J Rheumatol 2011;2011:845496. https://doi.org/10.1155/2011/845496
Kumar SS, Bagepally BS, Sasidharan A. Cost effectiveness of rituximab therapy for rheumatoid arthritis: A systematic review and meta-analysis of cost-utility studies. Clin Drug Investig 2023;43(2):97-108. https://doi.org/10.1007/s40261-022-01238-3
Kuwana M, Tamura N, Yasuda S, et al. Cost-effectiveness analyses of biologic and targeted synthetic disease-modifying anti-rheumatic diseases in patients with rheumatoid arthritis: Three approaches with a cohort simulation and real-world data. Mod Rheumatol 2023;33(2):302-211. https://doi. org/10.1093/mr/roac038
Gharaibeh M, Bonafede M, McMorrow D, Hernandez EJM, Stolshek BS. Effectiveness and costs among rheumatoid arthritis patients treated with targeted immunomodulators using real- world U.S. data. J Manag Care Spec Pharm 2020;26(8):1039-1049. https://doi.org/10.18553/ jmcp.2020.26.8.1039
VandeLaarCJ,OudeVoshaarMA,FakhouriWK,etal.Cost-effectivenessofaJAK1/JAK2inhibitor vs a biologic disease-modifying antirheumatic drug (bDMARD) in a treat-to-target strategy for rheumatoid arthritis. Clinicoecon Outcomes Res 2020;12:213-222. https://doi.org/10.2147/CEOR. S231558
Prawjaeng J, Leelahavarong P, Budtarad N, et al. Cost-utility analysis of biologic disease-modifying antirheumatic drugs (bDMARDs), targeted synthetic DMARDs (tsDMARDs) and biosimilar DMARDs (bsDMARDs) combined with methotrexate for Thai rheumatoid arthritis patients with high disease activity. BMC Health Serv Res 2023;23(1):561. https://doi.org/10.1186/s12913-023-09595-1
Mittal G, Bisht M, Pai VS, Handu S. The cost-effectiveness of and adherence to disease-modifying antirheumatic drug (DMARD) therapy in rheumatoid arthritis patients in a tertiary care teaching hospital in Uttarakhand, India. Cureus 2023;15(2):e34664. https://doi.org/10.7759/cureus.34664
Fellous S, Rkain H, Ahid S, et al. One-year direct costs of biological therapy in rheumatoid arthritis and its predictive factors: Data from the Moroccan RBSMR registry. Rheumatol Int 2021;41(4):787-793. https://doi.org/10.1007/s00296-020-04762-7
Said SS, Kühl M-J, Fevang B-TS, Nystad TW, Johansson KA. Treating rheumatoid arthritis in Zanzibar: A cost effectiveness study comparing conventional, biologic, and targeted-synthetic disease modifying anti-rheumatic drugs. medRxiv 2023;2023.12.05.23299489. https://doi. org/10.1101/2023.12.05.23299489
VanderTogtCJ,vandenBemtB,AletahaD,etal.Pointstoconsiderforcost-effectiveuseofbiological and targeted synthetic DMARDs in inflammatory rheumatic diseases: Results from an umbrella review and international Delphi study. RMD Open 2023;9(1):e002898. https://doi.org/10.1136/ rmdopen-2022-002898
Smolen JS, Caporali R, Doerner T, et al. Treatment journey in rheumatoid arthritis with biosimilars: From better access to good disease control through cost savings and prevention of nocebo effects. RMD Open 2021;7(2):e001637. https://doi.org/10.1136/rmdopen-2021-001637
Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis 2019;78(6):736-745. https://doi. org/10.1136/annrheumdis-2019-215089
Kowal-Bielecka O, Fransen J, Avouac J, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis 2017;76(8):1327-1339. https://doi.org/10.1136/ annrheumdis-2016-209909
Paik JJ, Casciola‐Rosen L, Shin JY, et al. Study of tofacitinib in refractory dermatomyositis: An open‐ label pilot study of ten patients. Arthritis Rheumatol 2021;73(5):858-865. https://doi.org/10.1002/ art.41602
Tjärnlund A, Tang Q, Wick C, et al. Abatacept in the treatment of adult dermatomyositis and polymyositis: A randomised, phase IIb treatment delayed-start trial. Ann Rheum Dis 2018;77(1):55- 62. https://doi.org/10.1136/annrheumdis-2017-211751
Hellmich B, Sanchez-Alamo B, Schirmer JH, et al. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis 2024;83(1):30-47. https://doi.org/10.1136/ ard-2022-223764
Kang L, Liu Y, Luo Z, et al. Systematic review and meta-analysis of the current literature on tocilizumab in patients with refractory Takayasu arteritis. Front Immunol 2023;14:1084558. https:// doi.org/10.3389/fimmu.2023.1084558
Hatemi G, Christensen R, Bang D, et al. 2018 update of the EULAR recommendations for the management of Behçet’s syndrome. Ann Rheum Dis 2018;77(6):808-818. https://doi.org/10.1136/ annrheumdis-2018-213225
Davidson L, van den Reek JM, Bruno M, et al. Risk of candidiasis associated with interleukin-17 inhibitors: A real-world observational study of multiple independent sources. Lancet Reg Health Eur 2022;13:100266. https://doi.org/10.1016/j.lanepe.2021.100266
Fauny M, Moulin D, d’Amico F, et al. Paradoxical gastrointestinal effects of interleukin-17 blockers. Ann Rheum Dis 2020;79(9):1132-1138. https://doi.org/10.1136/annrheumdis-2020-217927
Choy EH. Clinical significance of Janus kinase inhibitor selectivity. Rheumatology 2019;58(6):953-962.
https://doi.org/10.1093/rheumatology/key339
Nash P, Kerschbaumer A, Dörner T, et al. Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: A consensus statement. Ann Rheum Dis 2021;80(1):71-87. https://doi.org/10.1136/annrheumdis-2020-218398
Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med 2022;386(4):316-326. https://doi.org/10.1056/NEJMoa2109927
Mori S, Ogata F, Tsunoda R. Risk of venous thromboembolism associated with Janus kinase inhibitors for rheumatoid arthritis: Case presentation and literature review. Clin Rheumatol 2021;40(11):4457- 4471. https://doi.org/10.1007/s10067-021-05911-4
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