Safety of biological and targeted synthetic disease-modifying antirheumatic drugs for rheumatoid arthritis as used in clinical practice: results from the ARTIS programme

被引:37
作者
Frisell, Thomas [1 ,7 ]
Bower, Hannah [1 ]
Morin, Matilda [1 ]
Baecklund, Eva [2 ]
Di Giuseppe, Daniela [1 ]
Delcoigne, Benedicte [1 ]
Feltelius, Nils [3 ]
Forsblad-d'Elia, Helena [4 ]
Lindqvist, Elisabet [5 ]
Lindstroem, Ulf [4 ]
Askling, Johan [1 ,6 ]
机构
[1] Karolinska Inst, Dept Med Solna, Clin Epidemiol Div, Stockholm, Sweden
[2] Uppsala Univ, Dept Med Sci, Sect Rheumatol, Uppsala, Sweden
[3] Uppsala Univ, Dept Publ Hlth & Caring Sci, Uppsala, Sweden
[4] Univ Gothenburg, Sahlgrenska Acad, Inst Med, Dept Rheumatol & Inflammat Res, Gothenburg, Sweden
[5] Lund Univ, Skane Univ Hosp, Dept Clin Sci Lund, Sect Rheumatol, Lund, Sweden
[6] Karolinska Univ Hosp, Rheumatol Theme Inflammat & Ageing, Stockholm, Sweden
[7] Karolinska Inst, Dept Med Solna, Clin Epidemiol Div, S-17164 Stockholm, Sweden
关键词
Antirheumatic Agents; Biological Therapy; Arthritis; Rheumatoid; Cardiovascular Diseases; Epidemiology; SERIOUS INFECTIONS; ETANERCEPT; RISK; NATIONWIDE; REGISTER; INFLIXIMAB; ADALIMUMAB; DIFFERENCE; SURVIVAL; COHORT;
D O I
10.1136/ard-2022-223762
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectiveLongitudinal clinical registry-infrastructures such as Anti-Rheumatic Therapies in Sweden (ARTIS) allow simultaneous comparison of the safety of individual immunomodulatory drugs used in clinical practice, with consistent definitions of treatment cohorts, follow-up and outcomes. Our objective was to assess and compare incidence rates of key safety outcomes for individual targeted synthetic or biological disease-modifying antirheumatic drugs (b/ts DMARDs) in rheumatoid arthritis (RA), updating previous reports and including newer treatments including Janus Kinase inhibitors (JAKi). MethodsNationwide register-based cohort study including all patients with RA in Sweden registered as starting any b/tsDMARD 1 January 2010 through 31 December 2020, followed until 30 June 2021 (N=20 117). The incidence rates of selected outcomes, identified through national healthcare registers, were compared between individual b/tsDMARDs, adjusted for confounding by demographics, RA disease characteristics and comorbidity. ResultsThere were marked differences in treatment discontinuations due to adverse events (rates per 1000 person-years ranged from 18 on rituximab to 57 on tofacitinib), but few significant differences were observed for the serious adverse events under study. Neither cardiovascular events nor general serious infections were more frequent on baricitinib or tofacitinib versus bDMARDs, but JAKi were associated with higher rates of hospital-treated herpes zoster (HR vs etanercept, 3.82 (95% CI 2.05 to 7.09) and 4.00 (1.59 to 10.06)). Low number of events limited some comparisons, in particular for sarilumab and tofacitinib. ConclusionData from ARTIS supports that the b/tsDMARDs currently used to treat RA have acceptable and largely similar safety profiles, but differences exist in particular concerning tolerability and specific infection risks.
引用
收藏
页码:601 / 610
页数:10
相关论文
共 43 条
[1]  
Agency EM., 2017, PATIENT REGISTRY INI
[2]   Long-term anti-TNF therapy and the risk of serious infections in a cohort of patients with rheumatoid arthritis: Comparison of adalimumab, etanercept and infliximab in the GISEA registry [J].
Atzeni, Fabiola ;
Sarzi-Puttini, Piercarlo ;
Botsios, Costantino ;
Carletto, Antonio ;
Cipriani, Paola ;
Favalli, Ennio Giulio ;
Frati, Elena ;
Foschi, Valentina ;
Gasparini, Stefania ;
Giardina, AnnaRita ;
Gremese, Elisa ;
Iannone, Florenzo ;
Sebastiani, Marco ;
Ziglioli, Tamara ;
Biasi, Domenico ;
Ferri, Clodoveo ;
Galeazzi, Mauro ;
Gerli, Roberto ;
Giacomelli, Roberto ;
Gorla, Roberto ;
Govoni, Marcello ;
Lapadula, Giovanni ;
Marchesoni, Antonio ;
Salaffi, Fausto ;
Punzi, Leonardo ;
Triolo, Giovanni ;
Ferraccioli, Gianfranco .
AUTOIMMUNITY REVIEWS, 2012, 12 (02) :225-229
[3]   Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies [J].
Austin, Peter C. ;
Stuart, Elizabeth A. .
STATISTICS IN MEDICINE, 2015, 34 (28) :3661-3679
[4]   Effectiveness of baricitinib and tofacitinib compared with bDMARDs in RA: results from a cohort study using nationwide Swedish register data [J].
Barbulescu, Andrei ;
Askling, Johan ;
Chatzidionysiou, Katerina ;
Forsblad-d'Elia, Helena ;
Kastbom, Alf ;
Lindstrom, Ulf ;
Turesson, Carl ;
Frisell, Thomas .
RHEUMATOLOGY, 2022, 61 (10) :3952-3962
[5]   Efficacy of infliximab in treatment-resistant depression: A systematic review and meta-analysis [J].
Bavaresco, Daniela, V ;
Uggioni, Maria Laura Rodrigues ;
Ferraz, Sarah Dagostin ;
Machado Marques, Rudielly Moraes ;
Simon, Carla Sasso ;
Dagostin, Valdemira Santina ;
Grande, Antonio Jose ;
da Rosa, Maria Ines .
PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR, 2020, 188
[6]   A systematic review and meta-analysis of infection risk with small molecule JAK inhibitors in rheumatoid arthritis [J].
Bechman, Katie ;
Subesinghe, Sujith ;
Norton, Sam ;
Atzeni, Fabiola ;
Galli, Massimo ;
Cope, Andrew P. ;
Winthrop, Kevin L. ;
Galloway, James B. .
RHEUMATOLOGY, 2019, 58 (10) :1755-1766
[7]   Efficacy, duration of use and safety of glucocorticoids: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis [J].
Bergstra, Sytske Anne ;
Sepriano, Alexandre ;
Kerschbaumer, Andreas ;
van der Heijde, Desiree ;
Caporali, Roberto ;
Edwards, Christopher John ;
Verschueren, Patrick ;
de Souza, Savia ;
Pope, Janet E. ;
Takeuchi, Tsutomu ;
Hyrich, Kimme L. ;
Winthrop, Kevin L. ;
Aletaha, Daniel ;
Stamm, Tanja A. ;
Schoones, Jan W. ;
Smolen, Josef S. ;
Landewe, Robert B. M. .
ANNALS OF THE RHEUMATIC DISEASES, 2023, 82 (01) :81-94
[8]   GRADE approach to drawing conclusions from a network meta-analysis using a minimally contextualised framework [J].
Brignardello-Petersen, Romina ;
Florez, Ivan D. ;
Izcovich, Ariel ;
Santesso, Nancy ;
Hazlewood, Glen ;
Alhazanni, Waleed ;
Yepes-Nunez, Juan Jose ;
Tomlinson, George ;
Schunemann, Holger J. ;
Guyatt, Gordon H. .
BMJ-BRITISH MEDICAL JOURNAL, 2020, 371
[9]   Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU [J].
Butler, Dianne ;
Vucic, Katarina ;
Straus, Sabine ;
Cupelli, Amelia ;
Micallef, Benjamin ;
Serracino-Inglott, Anthony ;
Borg, John-Joseph .
EXPERT OPINION ON DRUG SAFETY, 2021, 20 (07) :815-826
[10]   Short-term, intermediate-term and long-term risks of acute coronary syndrome in cohorts of patients with RA starting biologic DMARDs: results from four Nordic countries [J].
Delcoigne, Benedicte ;
Ljung, Lotta ;
Provan, Sella A. ;
Glintborg, Bente ;
Hetland, Merete Lund ;
Gron, Kathrine Lederballe ;
Peltomaa, Ritva ;
Relas, Heikki ;
Turesson, Carl ;
Gudbjornsson, Bjorn ;
Michelsen, Brigitte ;
Askling, Johan .
ANNALS OF THE RHEUMATIC DISEASES, 2022, 81 (06) :789-797