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10 Publications visible to you, out of a total of 10
EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update.

Abstract (Expand)

OBJECTIVES: To update the existing European Alliance of Associations for Rheumatology (EULAR) points to consider (PtC) for use of antirheumatic drugs in reproduction, pregnancy, and lactation, including … additional drugs and adverse outcomes as well as paternal drug safety. METHODS: According to the EULAR standardised operating procedures, an international task force (TF) defined the questions for a systematic literature review, followed by formulation of the updated statements. A predefined voting process was applied to each overarching principle and statement. Level of evidence and strength of recommendation were assigned, and participants finally provided their level of agreement for each item. RESULTS: The TF proposes 5 overarching principles and 12 recommendations for the use of antirheumatic drugs before and during pregnancy, through lactation, and in male patients. The current evidence indicates that synthetic disease-modifying antirheumatic drugs (DMARDs) compatible with pregnancy include antimalarials, azathioprine, colchicine, cyclosporine, sulfasalazine, and tacrolimus. Regarding nonsteroidal anti-inflammatory drugs (NSAIDs) and glucocorticoids, a more restrictive approach to their use during pregnancy is recommended. Based on an individualised risk-benefit assessment, all tumour necrosis factor inhibitor (TNFi) biologic DMARDs (bDMARDs) can be used throughout pregnancy, and non-TNFi bDMARDs may be used if needed. In relation to lactation, compatible drugs include antimalarials, azathioprine, colchicine, cyclosporine, glucocorticoids, intravenous immunoglobulin (IVIG), NSAIDs, sulfasalazine, and tacrolimus. All bDMARDs are considered compatible with breastfeeding. Concerning the use of drugs in men, compatible options include antimalarials, azathioprine, colchicine, cyclosporine, IVIG, leflunomide, methotrexate, mycophenolate, NSAIDs, glucocorticoids, sildenafil, sulfasalazine, tacrolimus, and bDMARDs. CONCLUSIONS: The updated recommendations provide consensus guidance and will help to improve the quality of care of patients during the phases of reproduction, pregnancy, and lactation.

Authors: L. Ruegg, A. Pluma, S. Hamroun, I. Cecchi, L. F. Perez-Garcia, P. O. Anderson, L. Andreoli, S. B. Wirstrom, V. Boyadhzieva, C. Chambers, N. Costedoat-Chalumeau, R. J. E. M. Dolhain, R. Fischer-Betz, I. Giles, C. Gotestam-Skorpen, M. Hoeltzenbein, F. Marchiori, K. Mayer-Pickel, A. Molto, C. Nelson-Piercy, O. H. Nielsen, A. Tincani, M. Wallenius, A. Zbinden, Y. Meissner, A. Finckh, F. Forger

Date Published: 8th Jun 2025

Publication Type: Journal Article

Comparative risk of incident malignancies in rheumatoid arthritis patients treated with Janus kinase inhibitors or bDMARDs: observational data from the German RABBIT register

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ABSTRACT Objectives To estimate the effects of Janus kinase inhibitors (JAKis) vs biologic disease-modifying antirheumatic drugs (bDMARDs) on the risk of incident malignancies (excluding nonmelanoma … skin cancer) in patients and patient subgroups with rheumatoid arthritis. Methods Episodes of disease-modifying antirheumatic drug (DMARD) treatment initiated between January 2017 and December 2020 and followed up to June 2024 in RABBIT, the German register for the long-term observation of therapy with biologics and targeted disease-modifying antirheumatic drugs in adult patients with rheumatoid arthritis, were analysed. Incidence rates (IRs) per 1000 patient-years with 95% CIs were calculated, and incident malignancy risk was estimated as hazard ratios (HRs) by inverse probability weighted adjusted Cox models. Results Among 2285 JAKi and 4259 bDMARD treatment episodes, 88 and 135 malignancies occurred, respectively. JAKi treatments were dominated by baricitinib and tofacitinib, while most bDMARD treatments comprised tumour necrosis factor inhibitors. IRs were 11.6 (95% CI: 9.3, 14.3) in JAKi- and 8.9 (95% CI: 7.4, 10.5) in bDMARD-treated groups. The adjusted HR comparing JAKis with bDMARDs was 1.40 (95% CI: 1.09, 1.80). An increase in the malignancy risk for JAKi vs bDMARD treatment could only be observed in treatment episodes lasting longer than 16 months. The risk appeared higher in some subgroups of patients, including those who started treatment aged ≥60 years, patients with ≥3 prior conventional synthetic DMARD treatments, and patients with high disease activity. Conclusions In this German observational cohort study, an overall small increase in malignancy risk for JAKi vs bDMARD treatment was observed, with more pronounced risks in some subgroups of patients. The observed risk should be carefully counterbalanced to the known malignancy risk associated with insufficient disease control.

Authors: Martin Schaefer, Alina Purschke, Vera Zietemann, Tatjana Rudi, Yvette Meissner, Adrian Richter, Sylvia Berger, Karin Rockwitz, Klaus Krüger, Karl Matthias Schneider, Anne C. Regierer, Anja Strangfeld

Date Published: 2025

Publication Type: Journal Article

[Insights into pregnancy and breastfeeding in inflammatory rheumatic diseases through observational data]

Abstract (Expand)

Information on pregnancy and breastfeeding in women with chronic inflammatory rheumatic diseases is relevant for a successful pregnancy and also for maternal and child health. In general, pregnant and … breastfeeding women are excluded from randomized clinical trials and therefore evidence for clinical care and counselling has to be generated from observational studies. In the past decades, various data collections have been established for this purpose in addition to the existing spontaneous reporting systems initiated by drug authorities, with the aim of monitoring the teratogenic risk of a drug. Health insurance claims data, electronic health records and Scandinavian registers are also increasingly being used for research on pregnancy-associated events; however, all these data sources lack the inclusion of the maternal disease, especially with respect to its inflammatory component. Established cohort studies, biologics and disease registries record disease activity but are not designed for pregnancy-specific questions. Pregnancy registries and studies in rheumatology close this gap. In order to be able to make a better assessment of the possibilities and limitations of existing data sources on pregnancy and lactation, they are presented in detail in the following review including their respective advantages and disadvantages and examples from rheumatology are given. In addition, existing collaborations as well as studies for investigating the influence of paternal rheumatic disease are highlighted.

Authors: Y. Meissner, A. Strangfeld

Date Published: 2021

Publication Type: Journal Article

EULAR recommendations for a core data set for pregnancy registries in rheumatology.

Abstract (Expand)

BACKGROUND AND OBJECTIVE: There is an urgent need for robust data on the trajectories and outcomes of pregnancies in women with inflammatory rheumatic diseases (IRD). In particular when rare outcomes … or rare diseases are to be investigated, collaborative approaches are required. However, joint data analyses are often limited by the heterogeneity of the different data sources.To facilitate future research collaboration, a European League Against Rheumatism (EULAR) Task Force defined a core data set with a minimum of items to be collected by pregnancy registries in rheumatology covering the period of pregnancy and the 28-day neonatal phase in women with any underlying IRD. METHODS: A stepwise process included a two-round Delphi survey and a face-to-face meeting to achieve consensus about relevant items. RESULTS: A total of 64 multidisciplinary stakeholders from 14 different countries participated in the two rounds of the Delphi process. During the following face-to-face meeting of the EULAR Task Force, consensus was reached on 51 main items covering 'maternal information', 'pregnancy' and 'treatment'. Generic instruments for assessment are recommended for every item. Furthermore, for the five most frequent IRDs rheumatoid arthritis, spondyloarthritis, juvenile idiopathic arthritis, systemic lupus erythematosus and other connective tissue diseases, disease-specific laboratory markers and disease activity measurements are proposed. CONCLUSION: This is the first consensus-based core data set for prospective pregnancy registries in rheumatology. Its purpose is to stimulate and facilitate multinational collaborations that aim to increase the knowledge about pregnancy course and safety of treatment in women with IRDs during pregnancy.

Authors: Y. Meissner, R. Fischer-Betz, L. Andreoli, N. Costedoat-Chalumeau, D. De Cock, R. J. E. M. Dolhain, F. Forger, D. Goll, A. Molto, C. Nelson-Piercy, R. Ozdemir, L. Raio, S. C. Rodriguez-Garcia, S. Sciascia, M. Wallenius, A. Zbinden, A. Zink, A. Strangfeld

Date Published: 16th Oct 2020

Publication Type: Journal Article

European Network of Pregnancy Registers in Rheumatology (EuNeP)-an overview of procedures and data collection

Abstract (Expand)

BACKGROUND: The collaborative initiative of the European Network of Pregnancy Registers in Rheumatology (EuNeP) aims to combine data available in nationwide pregnancy registers to increase knowledge … on pregnancy outcomes in women with inflammatory rheumatic diseases (IRD) and on drug safety during pregnancy and lactation. The objective of this study was to describe the similarities and differences of the member registers. METHODS: From all registers, information about their structure and design was collected, as well as which parameters regarding demographics, maternal outcomes, treatment, course and outcome of pregnancy, and development of the child were available in the respective datasets. Furthermore, the current recruitment status was reported. RESULTS: The four registers (EGR2 (France), RePreg (Switzerland), RevNatus (Norway), and Rhekiss (Germany)) collect information prospectively and nationwide. Patients can be enrolled before conception or during pregnancy. To date, more than 3500 patients in total have been included, and data on 2200 pregnancies with an outcome are available. The distribution of diagnoses in the respective registers varies considerably, and only three entities (rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis) are captured by all the registers. Broad consistency was found in non-disease-specific data items, but differences regarding instruments and categories as well as frequency of data collection were revealed. Disease-specific data items are less homogeneously collected. CONCLUSION: Although the registers in this collaboration have similar designs, we found numerous differences in the variables collected. This survey of the status quo of current pregnancy registers is the first step towards identifying data collected uniformly across registers in order to facilitate joint analyses. TRIAL REGISTRATION: Not applicable.

Authors: Y. Meissner, A. Strangfeld, N. Costedoat-Chalumeau, F. Forger, D. Goll, A. Molto, R. Ozdemir, M. Wallenius, R. Fischer-Betz

Date Published: 2019

Publication Type: Journal Article

[How frequent are poor prognostic markers in rheumatoid arthritis? : An estimate based on three epidemiologic cohorts]

Abstract (Expand)

BACKGROUND: Unfavorable prognostic factors-high disease activity, early erosions, and autoantibodies-should be considered when making treatment decisions in rheumatoid arthritis (RA). There are little … data on the frequency of individual poor prognostic factors among RA patients in daily care. METHODS: Disease activity (Disease Activity Score, DAS28), erosions, antibodies against citrullinated peptides or rheumatoid factor (ACPA/RF+), previous treatment failure, inflammation markers, and functional disability (FFbH < 70) were defined as prognostic factors. Different treatment decision making situations were evaluated in disease-modifying antirheumatic drug (DMARD)-naive patients from the early RA CAPEA cohort (n = 1059), and in patients from the biologics register RABBIT after failure of one (n = 2217) or more (n = 3280) conventional synthetic (cs)DMARDs or one (n = 1134) or more (n = 795) biologic (b)DMARDs. With the national database of German arthritis centers (NDB), the frequency of these factors was analyzed according to treatment strata (no/1(st)/2(nd)/3(rd) DMARD; n = 5707). RESULTS: In DMARD-naive patients (CAPEA), 50% presented with DAS28 > 5.1, 64% were ACPA/RF+, 13% had erosions, and 37% functional disability (FFbH < 70). In RABBIT, 63 (1(st) csDMARD failure) to 81% (>/=2 bDMARD failures) were ACPA/RF+, 29 to 70% had erosions, 33 to 52% DAS28 > 5.1, and 41 to 66% had FFbH < 70, respectively. In the NDB, between 47 (DMARD-naive) and 82% (>/=2 previous DMARDs) were ACPA/RF+, 5 to 11%, had high disease activity under treatment (DAS28 > 5.1), and 26 to 50% had functional disability (FFbH < 70), respectively. CONCLUSION: With growing numbers of previous DMARD therapies, increasing proportions of patients have poor prognostic factors. This underlines the importance of these factors for a difficult-to-treat disease course.

Authors: K. Albrecht, A. Richter, Y. Meissner, D. Huscher, L. Baganz, K. Thiele, M. Schneider, A. Strangfeld, A. Zink

Date Published: 2017

Publication Type: Journal Article

Serious adverse events and the risk of stroke in patients with rheumatoid arthritis: results from the German RABBIT cohort

Abstract (Expand)

OBJECTIVE: In the general population, the incidence of stroke is increased following other serious events and hospitalisation. We investigated the impact of serious adverse events on the risk of stroke … in patients with rheumatoid arthritis (RA), taking risk factors and treatment into account. METHODS: Using data of the German biologics register RABBIT (Rheumatoid Arthritis: Observation of Biologic Therapy) with 12354 patients with RA, incidence rates (IRs) and risk factors for stroke were investigated using multi-state and Cox proportional hazard models. In addition, in a nested case-control study, all patients with stroke were matched 1:2 to patients with identical baseline risk profile and analysed using a shared frailty model. RESULTS: During follow-up, 166 strokes were reported. The overall IR was 3.2/1000 patient-years (PY) (95% CI 2.7 to 3.7). It was higher after a serious adverse event (IR: 9.0 (7.3 to 11.0)), particularly within 30 days after the event (IR: 94.9 (72.6 to 121.9)). The adjusted Cox model showed increased risks of age per 5 years (HR: 1.4 (1.3 to 1.5)), hyperlipoproteinaemia (HR: 1.6 (1.0 to 2.5)) and smoking (HR: 1.9 (1.3 to 2.6)). The risk decreased with better physical function (HR: 0.9 (0.8 to 0.96)). In the case-control study, 163 patients were matched to 326 controls. Major risk factors for stroke were untreated cardiovascular disease (HR: 3.3 (1.5 to 7.2)) and serious infections (HR:4.4 (1.6 to 12.5)) or other serious adverse events (HR: 2.6 (1.4 to 4.8)). CONCLUSIONS: Incident adverse events, in particular serious infections, and insufficient treatment of cardiovascular diseases are independent drivers of the risk of stroke. Physicians should be aware that patients who experience a serious event are at increased risk of subsequent stroke.

Authors: Y. Meissner, A. Richter, B. Manger, H. P. Tony, E. Wilden, J. Listing, A. Zink, A. Strangfeld

Date Published: 2017

Publication Type: Journal Article

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