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

Frisell, Thomas; Bower, Hannah; Morin, Matilda; Baecklund, Eva; Giuseppe, Daniela Di; Delcoigne, Bénédicte; Feltelius, Nils; Forsblad-d’Elia, Helena; Lindqvist, Elisabet; Lindström, Ulf; Askling, Johan

doi:10.1136/ard-2022-223762

Cited by 39 publications

(28 citation statements)

References 41 publications

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“…MTX was associated with a two-fold increased risk of skin cancer, but low doses of MTX do not increase the risk of cancers other than skin cancer. Lymphomas and non-melanoma skin cancers may be associated with Anti-TNF agents as well, results from the ARTIS program ( 52 ). Fortunately, a study published this year found that it was unclear whether long-term use of DMARDs increased the risk of malignancies.…”

Section: Discussionmentioning

confidence: 99%

Diseases of the musculoskeletal system and connective tissue and risk of breast cancer: Mendelian randomization study in European and East Asian populations

Wang

Chu

et al. 2023

Front. Oncol.

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ObjectiveAssociations between diseases of the musculoskeletal system and connective tissue (MSCTD) and breast cancer (BC) have not been elucidated completely. The purpose of this study was to investigate the associations of MSCTD, rheumatoid arthritis (RA), Sjogren syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), dermatomyositis (DM), polymyositis (PM), osteoarthritis (OA) of hip or knee, and ankylosing spondylitis (AS) with BC in European populations and East Asian populations using Mendelian randomized (MR) analysis.MethodsThe genetic instruments linked to MSCTD, RA, SS, SLE, SSc, DM, PM, OA, and AS were chosen from the EBI database of complete genome-wide association studies (GWAS) summary data and the FinnGen consortium. The associations of genetic variants with BC were extracted from the Breast Cancer Association Consortium (BCAC). Two Sample MR was performed using summary data from GWAS, principally using the inverse variant weighted (IVW) method. Heterogeneity, pleiotropy, and sensitivity analyses were performed to evaluate the robustness of the results by weighted median, MR Egger, simple mode, weighted mode, and leave-one-out analysis.ResultsIn the European population, causal relationships between RA and BC (OR=1.04, 95%CI: 1.01-1.07, P=0.023), AS and BC (OR=1.21, 95%CI: 1.06-1.36, P=0.013) were confirmed. IVW analysis showed DM (OR=0.98, 95%CI: 0.96-0.99, P=0.026) and PM (OR=0.98, 95%CI: 0.97-0.99, P=0.002) were associated with slightly decreased risks of estrogen receptor (ER)+ BC, and MSCTD was associated with an increased risk of ER- BC (OR=1.85, 95%CI: 1.27-2.44, P=0.039). There was no causal relationship between SLE, SS, SSc, OA, and BC, neither ER+ BC nor ER- BC. However, in the East Asian population, IVW analysis showed that RA (OR=0.94, 95%CI: 0.89-0.99, P=0.0096) and SLE (OR=0.95, 95%CI: 0.92-0.99, P=0.0058) was associated with decreased risks of BC.ConclusionsThis study suggests that causal relationships between patients with MSCTD and BC in the European population are different from those in the East Asian population, patients with RA and AS in the European population have an increased risk of BC, patients with MSCTD have increased risk of ER- BC in the European population, while patients with RA and SLE in the East Asian population have decreased risk of BC.

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Section: Discussionmentioning

confidence: 99%

Diseases of the musculoskeletal system and connective tissue and risk of breast cancer: Mendelian randomization study in European and East Asian populations

Wang

Chu

et al. 2023

Front. Oncol.

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“…The existing literature on the combination of bdMARDs and tsDMARDs is limited, probably because of academics raising signi cant concerns regarding potential adverse events including serious infections, cardiovascular complications, thrombotic events, and malignancies [15]. Our research team has conducted a trial evaluating the e cacy and safety of combining tofacitinib with bDMRAD in the treatment of ankylosing spondylitis (AS), and preliminary ndings from small-scale studies have demonstrated favorable results [16].…”

Section: Discussionmentioning

confidence: 99%

A retrospective study of efficacy of tofacitinib combined with bDMARDs in the treatment of rheumatoid arthritis patients with inadequate response to bDMARDs

Chang,

Wang

2024

Preprint

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Introduction: Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by synovial inflammation, joint swelling, and pain involving multiple joints. While biologic disease-modifying antirheumatic drugs(bDMARDs) and targeted synthetic DMARDs(tsDMARDs) are popular treatments for RA, there is limited research on their combined use. This study examined a cohort of RA patients who demonstrated inadequate response to bDMARDs and subsequently initiated combination therapy with tofacitinib and bDMARDs, assessing both the efficacy and safety profile of this therapeutic approach. Methods: In this study, we retrospectively collected the electronic medical records (EMR) of 56 adult patients with RA who were admitted to the Fourth Affiliated Hospital Zhejiang University School of Medicine between August 2018 to December 2022. All patients had received at least one bDMARD treatment for more than three months and still exhibited moderate to high disease activity. Tofacitinib 5mg bid was added to their original biological treatment in 28 cases, and other 28 cases switched to another bDMARD or tsDMARD as control group. Treatment was continued for 60weeks following the initiation of combination therapy. Changes in DAS28-CRP and ACR20 response rate at week 60 were collected and analyzed from baseline, while changes in C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) at weeks 4, 8, 12 followed by subsequent assessments every 12 weeks until the completion of the 60-week study period were also collected and analyzed. Results: After 60 weeks of treatment, the DAS28-CRP score in combined treatment group decreased significantly from a baseline of 5.16±0.91 (3.86~8.21) to 2.64±0.85 (1.39~5.13), with remission achieved by 19 patients (67.9%) and low disease activity achieved by 5 patients (17.9%). The DAS28-CRP in the control group exhibited a decrease from 5.20±0.79 (3.88~7.21) at baseline to 3.23±1.27 (1.53~5.59). 10 patients (35.7%) achieved remission, while another 10 patients (35.7%) achieved low disease activity. The ACR20 response rate was 85.71% in the combined treatment group, whereas it was 71.43% in the control group. Additionally, both ESR and CRP levels decreased significantly during the course of treatment without any reported adverse events leading to discontinuation. Conclusion: Our findings offer some evidence, supporting the effectiveness and safety of combining bDMARD with JAKi tofacitinib in RA patients who have an inadequate response to bDMARD monotherapy. This combination effectively manages disease activity while maintaining a relatively low and manageable incidence of adverse events.Further prospective randomized controlled trials with large sample sizes are anticipated to provide evidence-based medical support.

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“…The Safety of TofAcitinib in Routine Care Patients with Rheumatoid Arthritis (STAR-RA) multi-database, population-based study of 102,263 RA patients (larger than ORAL surveillance trial and CORRONA RA registry study) found no increased risk of CV outcomes with tofacitinib in the real world [ 63 ]. The ARTIS trial (Anti-Rheumatic Therapies in Sweden), a 10-year large cohort, found no difference in MACE incidence between tsDMARDs and bDMARDs [ 64 ]. Data from the German RABBIT register shows that tsDMARDs did not show a high frequency of MACE compared to other DMARDs [ 65 ].…”

Section: Reviewmentioning

confidence: 99%

2023 Management Recommendations of Bangladesh Rheumatology Society on Pharmacological Treatment of Rheumatoid Arthritis With Synthetic and Biologic Disease-Modifying Drugs

Momen Majumder,

Hasan,

Choudhury

et al. 2024

Cureus

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Rheumatoid arthritis (RA) is the most common inflammatory polyarthritis in Bangladesh. Bangladesh Rheumatology Society (BRS) proposes these management recommendations to treat the considerable burden of RA in the resource-constrained situation based on the best current evidence combined with societal challenges and opportunities. BRS formed a task force (TF) comprising four rheumatologists. The TF searched for all available literature, including updated American College of Rheumatology (ACR), European Alliance of Associations for Rheumatology (EULAR), and Asia‐Pacific League of Associations for Rheumatology (APLAR) and several other guidelines, and systematic literature reviews until October 2023, and then a steering committee was formed, which included rheumatologists and internists. We followed the EULAR standard operating procedures to categorize levels of evidence and grading of recommendations. This recommendation has two parts -- general (diagnosis of RA, nomenclature of disease-modifying anti-rheumatic drugs [DMARDs], disease activity indices) and management portion. The TF agreed on four overarching principles and 12 recommendations. Overarching principles deal with early diagnosis and disease activity monitoring. Recommendations 1-5 discuss using glucocorticoids, NSAIDs, and conventional synthetic DMARDs (csDMARD). Recommendations 6-9 stretch the use of targeted synthetic DMARDs (tsDMARDs) and biological DMARDs (bDMARDs). The suggested DMARD therapy includes initiation with methotrexate (MTX) or another csDMARD (in case of contraindication to MTX) in the first phase and the addition of a tsDMARD in the second phase, switching to an alternative tsDMARDs or bDMARDs in the subsequent phases. The TF included the Padua prediction score for the thromboembolism risk estimation. Recommendations 10-12 cover infection screening, vaccination, and DMARD tapering. Bangladesh has a higher prevalence of RA. This recommendation will serve as a tool to treat this high burden of patients with RA scientifically and more effectively.

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

Cited by 39 publications

References 41 publications

Diseases of the musculoskeletal system and connective tissue and risk of breast cancer: Mendelian randomization study in European and East Asian populations

Diseases of the musculoskeletal system and connective tissue and risk of breast cancer: Mendelian randomization study in European and East Asian populations

A retrospective study of efficacy of tofacitinib combined with bDMARDs in the treatment of rheumatoid arthritis patients with inadequate response to bDMARDs

2023 Management Recommendations of Bangladesh Rheumatology Society on Pharmacological Treatment of Rheumatoid Arthritis With Synthetic and Biologic Disease-Modifying Drugs

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