Publications

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216 Publications visible to you, out of a total of 216
Impact of DMARD treatment and systemic inflammation on all-cause mortality in patients with rheumatoid arthritis and interstitial lung disease: a cohort study from the German RABBIT register

Abstract (Expand)

OBJECTIVES: To investigate the impact of disease activity and treatment with disease-modifying antirheumatic drugs (DMARDs) on all-cause mortality in patients with rheumatoid arthritis and prevalent … interstitial lung disease (RA-ILD). METHODS: Patients with RA-ILD were selected from the biologics register Rheumatoid Arthritis: Observation of Biologic Therapy (RABBIT). Using time-varying Cox regression, the association between clinical measures and mortality was investigated. The impact of DMARDs was analysed by (1) Cox regression considering cumulative exposure (ie, treatment months divided by total months) and (2) time-varying Cox regression as main approach (treatment exposures at monthly level). RESULTS: Out of 15 566 participants, 381 were identified as RA-ILD cases with 1258 person-years of observation and 2.6 years median length of follow-up. Ninety-seven patients (25.5%) died and 34 (35.1%) of these were not receiving DMARD therapy at the time of death. Higher inflammatory biomarkers but not swollen and tender joint count were significantly associated with mortality. Compared with tumour necrosis factor inhibitors (TNFi), non-TNFi biologic DMARDs (bDMARDs) exhibited adjusted HRs (aHRs) for mortality below 1, lacking statistical significance. This finding was stable in various sensitivity analyses. Joint aHR for non-TNFi biologics and JAKi versus TNFi was 0.56 (95% CI 0.33 to 0.97). Receiving no DMARD treatment was associated with a twofold higher mortality risk compared with receiving any DMARD treatment, aHR 2.03 (95% CI 1.23 to 3.35). CONCLUSIONS: Inflammatory biomarkers and absence of DMARD treatment were associated with increased risk of mortality in patients with RA-ILD. Non-TNFi bDMARDs may confer enhanced therapeutic benefits in patients with RA-ILD.

Authors: T. Rudi, V. Zietemann, Y. Meissner, A. Zink, A. Krause, H. M. Lorenz, C. Kneitz, M. Schaefer, A. Strangfeld

Date Published: 2024

Publication Type: Journal

Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: a comprehensive evaluation of randomised controlled trials and observational studies

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OBJECTIVES: This study aims to evaluate non-melanoma skin cancer (NMSC) risk associated with abatacept treatment for rheumatoid arthritis (RA). METHODS: This evaluation included 16 abatacept RA clinical … trials and 6 observational studies. NMSC incidence rates (IRs)/1000 patient-years (p-y) of exposure were compared between patients treated with abatacept versus placebo, conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biological/targeted synthetic (b/ts)DMARDs. For observational studies, a random-effects model was used to pool rate ratios (RRs). RESULTS:  49 000 patients receiving abatacept were analysed from clinical trials ( 7000) and observational studies ( 42 000). In randomised trials (n=4138; median abatacept exposure, 12 (range 2-30) months), NMSC IRs (95% CIs) were not significantly different for abatacept (6.0 (3.3 to 10.0)) and placebo (4.0 (1.3 to 9.3)) and remained stable throughout the long-term, open-label period (median cumulative exposure, 28 (range 2-130 months); 21 335 p-y of exposure (7044 patients over 3 years)). For registry databases, NMSC IRs/1000 p-y were 5-12 (abatacept), 1.6-10 (csDMARDs) and 3-8 (other b/tsDMARDs). Claims database IRs were 19-22 (abatacept), 15-18 (csDMARDs) and 14-17 (other b/tsDMARDs). Pooled RRs (95% CIs) from observational studies for NMSC in patients receiving abatacept were 1.84 (1.00 to 3.37) vs csDMARDs and 1.11 (0.98 to 1.26) vs other b/tsDMARDs. CONCLUSIONS: Consistent with the warnings and precautions of the abatacept label, this analysis suggests a potential increase in NMSC risk with abatacept use compared with csDMARDs. No significant increase was observed compared with b/tsDMARDs, but the lower limit of the 95% CI was close to unity.

Authors: T. A. Simon, L. Dong, S. Suissa, K. Michaud, S. Pedro, M. Hochberg, M. Boers, J. Askling, T. Frisell, A. Strangfeld, Y. Meissner, V. Khaychuk, A. Dominique, M. A. Maldonado

Date Published: 2024

Publication Type: Journal

Malignancy outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study

Abstract (Expand)

OBJECTIVE: To evaluate the risk of malignancy (overall, breast, lung, and lymphoma) in patients with rheumatoid arthritis treated with abatacept, conventional synthetic (cs) disease-modifying antirheumatic … drugs (DMARDs), and other biologic/targeted synthetic (b/ts)DMARDs in clinical practice. METHODS: Four international observational data sources were included: ARTIS (Sweden), RABBIT (Germany), FORWARD (USA), and BC (Canada). Crude incidence rates (IRs) per 1000 patient-years of exposure with 95% confidence intervals (CIs) for a malignancy event were calculated; rate ratios (RRs) were estimated and adjusted for demographics, comorbidities, and other potential confounders. RRs were then pooled in a random-effects model. RESULTS: Across data sources, mean follow-up for patients treated with abatacept (n = 5182), csDMARDs (n = 73,755), and other b/tsDMARDs (n = 37,195) was 3.0-3.7, 2.9-6.2, and 3.1-4.7 years, respectively. IRs per 1000 patient-years for overall malignancy ranged from 7.6-11.4 (abatacept), 8.6-13.2 (csDMARDs), and 5.0-11.8 (other b/tsDMARDs). IRs ranged from: 0-4.4, 0-3.3, and 0-2.5 (breast cancer); 0.1-2.8, 0-3.7, and 0.2-2.9 (lung cancer); and 0-1.1, 0-0.9, and 0-0.6 (lymphoma), respectively, for the three treatment groups. The numbers of individual cancers (breast, lung, and lymphoma) in some registries were low; RRs were not available. There were a few cases of lymphoma in some of the registries; ARTIS observed an RR of 2.8 (95% CI 1.1-6.8) with abatacept versus csDMARDs. The pooled RRs (95% CIs) for overall malignancy with abatacept were 1.1 (0.8-1.5) versus csDMARDs and 1.0 (0.8-1.3) versus b/tsDMARDs. CONCLUSIONS: This international, post-marketing observational safety study did not find any statistically significant increase in the risk of overall malignancies in pooled data in patients treated with abatacept compared with csDMARDs or with other b/tsDMARDs. Assessment of larger populations is needed to further evaluate the risks for individual cancers, especially lymphoma.

Authors: T. A. Simon, S. Suissa, M. Boers, M. C. Hochberg, M. L. Skovron, J. Askling, K. Michaud, A. Strangfeld, S. Pedro, T. Frisell, Y. Meissner, A. Dominique, A. Gomez

Date Published: 2024

Publication Type: Journal

Infection outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study

Abstract (Expand)

OBJECTIVE: To evaluate risk of infections requiring hospitalization and opportunistic infections, including tuberculosis, in patients with rheumatoid arthritis (RA) treated with abatacept versus … conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biologic/targeted synthetic (b/ts) DMARDs. METHODS: Five international observational data sources were used: two biologic registries (Sweden, Germany), a disease registry (USA) and two healthcare claims databases (Canada, USA). Crude incidence rates (IRs) per 1000 patient-years, with 95 % CIs, were used to estimate rate ratios (RRs) comparing abatacept versus csDMARDs or other b/tsDMARDs. RRs were adjusted for demographic factors, comorbidities, and other potential confounders and then pooled across data sources using a random effects model (REM). RESULTS: The data sources included 6450 abatacept users, 136,636 csDMARD users and 54,378 other b/tsDMARD users, with a mean follow-up range of 2.2-6.2 years. Across data sources, the IRs for infections requiring hospitalization ranged from 16 to 56 for abatacept, 19-46 for csDMARDs, and 18-40 for other b/tsDMARDs. IRs for opportunistic infections were 0.4-7.8, 0.3-4.3, and 0.5-3.8; IRs for tuberculosis were 0.0-8.4, 0.0-6.0, and 0.0-6.3, respectively. The pooled adjusted RR (95 % CI), only reported for infections requiring hospitalization, was 1.2 (0.6-2.2) for abatacept versus csDMARDs and 0.9 (0.6-1.3) versus other b/tsDMARDs. CONCLUSIONS: Data from this international, observational study showed similar hospitalized infection risk for abatacept versus csDMARDs or other b/tsDMARDs. IRs for opportunistic infections, including tuberculosis, were low. These data are consistent with the known safety profile of abatacept.

Authors: T. A. Simon, S. Suissa, M. L. Skovron, T. Frisell, J. Askling, K. Michaud, S. Pedro, A. Strangfeld, Y. Meissner, M. Boers, V. Hoffman, A. Dominique, A. Gomez, M. C. Hochberg

Date Published: 2024

Publication Type: Journal

Recording of non-musculoskeletal manifestations, comorbidities and safety outcomes in European spondyloarthritis registries: a survey

Abstract (Expand)

OBJECTIVES: Real-world evidence is needed to inform treatment strategies for patients with PsA and axial SpA (axSpA) who have non-musculoskeletal manifestations (NMMs), various risk factors and … comorbidities. International collaboration is required to ensure statistical power and to enhance generalizability. The first step forward is identifying which data are currently being collected. Across 17 registries participating in the European Spondyloarthritis Research Collaboration (EuroSpA), we aimed to map recording practices for NMMs, comorbidities and safety outcomes in patients with PsA and axSpA. METHODS: Through a survey with 4,420 questionnaire items, we explored the recording practices of 58 pre-defined conditions (i.e. NMMs, comorbidities and safety outcomes) covering 10 disease areas. In all registries we mapped for each condition whether it was recorded, the recording procedure and the potential to identify it through linkage to other national registries. RESULTS: Conditions were generally recorded at entry into the registry and clinical follow-up visits using a pre-specified list or a coding system. Most registries recorded conditions within the following disease areas: NMMs (number of registries, n = 15-16), cardiovascular diseases (n = 10-14), gastrointestinal diseases (n = 12-13), infections (n = 10-13) and death (n = 14). Nordic countries had the potential for data linkage and generally had limited recording of conditions in their registry, while other countries had comprehensive recording practices. CONCLUSION: A wide range of conditions were consistently recorded across the registries. The recording practices of many conditions and disease areas were comparable across the registries. Our findings support the potential for future collaborative research.

Authors: Z. F. Ahmadzay, J. Heberg, J. B. Jørgensen, L. M. Ørnbjerg, M. Østergaard, S. Møller-Bisgaard, B. Michelsen, A. G. Loft, G. T. Jones, P. Hellamand, A. Scherer, M. J. Nissen, K. Pavelka, J. Závada, K. Laas, S. Vorobjov, D. Nordström, T. Sokka-Isler, A. C. Regierer, A. Reich, B. Gudbjornsson, K. Thorarinsdottir, F. Iannone, E. G. Favalli, M. van de Sande, S. A. Provan, T. K. Kvien, A. M. Rodrigues, C. F. Gonçalves, C. Codreanu, C. Mogosan, Z. Rotar, K. P. Prikmajer, I. Castrejon, L. Otero-Varela, D. Di Giuseppe, J. K. Wallman, A. Ciurea, B. Möller, G. Kenar-Artın, T. D. Yıldırım, G. J. Macfarlane, O. Rotariu, B. Glintborg, M. L. Hetland

Date Published: 2024

Publication Type: Journal

No difference in clinical parameters and drug retention in PsA patients receiving b/tsDMARD monotherapy versus combination with methotrexate: data from the RABBIT-SpA registry

Abstract (Expand)

BACKGROUND: The potential benefit of methotrexate (MTX) in combination with biologic (b) and targeted synthetic (ts) disease modifying anti-rheumatic drugs (DMARDs) in psoriatic arthritis (PsA) is still … a matter of debate. OBJECTIVES: To compare clinical and patient reported characteristics as well as drug retention rates in PsA patients receiving b/tsDMARD monotherapy or in combination with MTX. METHODS: RABBIT-SpA is a prospective longitudinal cohort study including axSpA and PsA patients. In this analysis, PsA patients were stratified into two groups: starting b/tsDMARD as monotherapy or in combination with MTX. Treatment retention was compared by drug survival analysis. RESULTS: 69% of the patients (n=900) started b/tsDMARD as monotherapy while 31% were treated in combination with MTX (n=405). At baseline, clinical domains like skin, nail and joint affection, dactylitis, enthesitis and axial involvement were similar between the groups. Only the patients’ satisfaction concerning tolerability of the previous treatment was significantly better in the combination group at treatment start. Drug retention rates did not differ between the groups (p=0.4). At 6/12 months, 66%/48% of patients in monotherapy and 67%/48% in the combination group were still on their original treatment. CONCLUSIONS: We did not identify any clinical parameters with notable influence on the choice of b/tsDMARD mono or MTX-combination therapy in PsA. Drug retention rates are similar between mono and combination therapy. It seems that the decision to continue MTX at initiation of b/tsDMARDs is mostly based on the subjective tolerability of MTX treatment.

Authors: A. C. Regierer, D. Kiefer, G. Schett, A. Krause, A. Weiss, P. Sewerin, A. Strangfeld

Date Published: 2024

Publication Type: Journal

RABBIT-SpA – nationale Registerdaten zu Spondyloarthritiden

Abstract (Expand)

Seit 2017 wird im Deutschen Rheuma-Forschungszentrum das Krankheitsregister RABBIT-SpA für die axiale Spondyloarthritis und die Psoriasis-Arthritis durchgeführt. Fast 80 rheumatologische Einrichtungen … in ganz Deutschland sind aktiv beteiligt. Es liegen inzwischen Daten von je über 1.800 Patient:innen für beide Erkrankungen vor. Da die Patient:innen zu Beginn einer neuen Therapie eingeschlossen werden, ist die Krankheitsaktivität im Vergleich zu anderen Kohorten aus dem Versorgungsalltag relativ hoch. Es wurden bereits einige Analysen der RABBIT-SpA-Patient:innen publiziert. Es konnte zum Beispiel gezeigt werden, dass die Therapieretention bei PsA-Patient:innen, die entweder mit einer b/tsDMARD-Monotherapie oder einer Kombination eines b/tsDMARDs mit MTX behandelt wurden, gleich war. Eine Analyse zur mentalen Gesundheit zeigte, dass bei ca. 30% der Patient:innen depressive Symptome vorliegen, sowohl bei der axSpA als auch bei der PsA. In einer weiteren Analyse wurden PsA-Patient:innen, die auch eine axiale Beteiligung haben mit den axSpA-Patient:innen, die auch eine Hautpsoriasis haben, verglichen. axPsA-Patient:innen waren älter und weniger häufig HLA-B27 positiv, zudem war der Frauenanteil höher, als bei den axSpA+Pso-Patient:innen. Die Krankheitslast gemessen z. B. an der globalen Krankheitsaktivität berichtet sowohl von den Ärzten als auch von den Patient:innen war sehr ähnlich in beiden Gruppen. Damit die Daten aus Krankheitsregistern nutzbringend analysiert werden können und zum Beispiel auch Analysen über Therapiesicherheit möglich sind, ist es wichtig, dass möglichst viele Patient:innen eingeschlossen werden und über eine lange Zeit im Register beobachtet werden. Deshalb freuen wir uns sehr über die aktive Mitarbeit so vieler Rheumtaolog:innen und ihrer Mitarbeiter:innen und heißen neue rheumatologische Einrichtungen jederzeit herzlich willkommen.

Authors: Anne C. Regierer, Anja Weiß

Date Published: 2024

Publication Type: Journal

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