Publications

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100 Publications visible to you, out of a total of 100
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

[Gender-specific differences in the diagnosis and treatment of inflammatory rheumatic diseases]

Abstract (Expand)

BACKGROUND: Gender differences in the diagnosis and treatment of various diseases are increasingly being researched with the aim of optimizing treatment strategies and improving individual treatment … success. METHODS: This paper summarizes the existing literature for gender differences in inflammatory rheumatic diseases. RESULTS: Many, but not all, inflammatory rheumatic diseases occur more frequently in women than in men. Women more often have a longer duration of symptoms until diagnosis than men, which may be due to different clinical and radiological presentations. Across diseases, women more often have lower remission and treatment response rates to antirheumatic medication compared to men. Discontinuation rates are also higher in women than in men. Whether women are more likely to develop anti-drug antibodies to biologic disease-modifying antirheumatic drugs is still unclear. For Janus kinase inhibitors, there is no evidence of differential treatment response to date. CONCLUSION: Whether individual dosing regimens and gender-adapted remission criteria are also required in rheumatology cannot be deduced from the evidence available to date.

Authors: K. Albrecht, A. Strangfeld

Date Published: 2023

Publication Type: Journal

Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update

Abstract (Expand)

BACKGROUND: Targeting interleukin (IL)-6 has become a major therapeutic strategy in the treatment of immune-mediated inflammatory disease. Interference with the IL-6 pathway can be directed at the … specific receptor using anti-IL-6Ralpha antibodies or by directly inhibiting the IL-6 cytokine. This paper is an update of a previous consensus document, based on most recent evidence and expert opinion, that aims to inform on the medical use of interfering with the IL-6 pathway. METHODS: A systematic literature research was performed that focused on IL-6-pathway inhibitors in inflammatory diseases. Evidence was put in context by a large group of international experts and patients in a subsequent consensus process. All were involved in formulating the consensus statements, and in the preparation of this document. RESULTS: The consensus process covered relevant aspects of dosing and populations for different indications of IL-6 pathway inhibitors that are approved across the world, including rheumatoid arthritis, polyarticular-course and systemic juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still’s disease, Castleman’s disease, chimeric antigen receptor-T-cell-induced cytokine release syndrome, neuromyelitis optica spectrum disorder and severe COVID-19. Also addressed were other clinical aspects of the use of IL-6 pathway inhibitors, including pretreatment screening, safety, contraindications and monitoring. CONCLUSIONS: The document provides a comprehensive consensus on the use of IL-6 inhibition to treat inflammatory disorders to inform healthcare professionals (including researchers), patients, administrators and payers.

Authors: D. Aletaha, A. Kerschbaumer, K. Kastrati, C. Dejaco, M. Dougados, I. B. McInnes, N. Sattar, T. A. Stamm, T. Takeuchi, M. Trauner, D. van der Heijde, M. Voshaar, K. L. Winthrop, A. Ravelli, N. Betteridge, G. R. Burmester, J. W. Bijlsma, V. Bykerk, R. Caporali, E. H. Choy, C. Codreanu, B. Combe, M. K. Crow, M. de Wit, P. Emery, R. M. Fleischmann, C. Gabay, M. L. Hetland, K. L. Hyrich, A. Iagnocco, J. D. Isaacs, J. M. Kremer, X. Mariette, P. A. Merkel, E. F. Mysler, P. Nash, M. T. Nurmohamed, K. Pavelka, G. Poor, A. Rubbert-Roth, H. Schulze-Koops, A. Strangfeld, Y. Tanaka, J. S. Smolen

Date Published: 2023

Publication Type: Journal

Integrated proteomics and genomics analysis of paradoxical eczema in psoriasis patients treated with biologics

Abstract (Expand)

BACKGROUND: Few studies have explored the immunology and genetic risk of paradoxical eczema occurring as an adverse event of biologic therapy in patients with psoriasis. OBJECTIVES: We sought to describe … the systemic inflammatory signature of paradoxical eczema using proteomics and explore whether this is genetically mediated. METHODS: This study used the Olink Target 96 Inflammation panel on 256 serum samples from 71 patients with psoriasis and paradoxical eczema, and 75 controls with psoriasis to identify differentially expressed proteins and enriched gene sets. Case samples from 1 or more time points (T1 prebiologic, T2 postbiologic, and T3 postparadoxical eczema) were matched 1:1 with control samples. Genes contributing to enriched gene sets were selected, and functional single nucleotide polymorphisms used to create polygenic risk scores in a genotyped cohort of 88 paradoxical eczema cases and 3124 psoriasis controls. RESULTS: STAMBP expression was lower in cases at T1 than in controls (log-fold change: -0.44; adjusted P = .022); no other proteins reached statistical significance at equivalent time points. Eleven gene sets including cytokine and chemokine pathways were enriched in cases at T2 and 10 at T3. Of the 39 proteins contributing to enriched gene sets, the majority are associated with the atopic dermatitis serum proteome. A polygenic risk score including 38 functional single nucleotide polymorphisms linked to enriched gene sets was associated with paradoxical eczema (adjusted P = .046). CONCLUSIONS: The paradoxical eczema systemic inflammatory proteome trends toward atopic dermatitis at a gene-set level and is detectable before onset of the phenotype. This signature could be genetically determined.

Authors: A. Al-Janabi, P. Martin, A. R. Khan, A. C. Foulkes, C. H. Smith, C. E. M. Griffiths, A. P. Morris, S. Eyre, R. B. Warren, Bstop Study Group, Badbir Study Group the

Date Published: 2023

Publication Type: Journal

Characterization of patients with psoriatic arthritis in dermatologic and rheumatologic care: analysis of two registries

Abstract (Expand)

BACKGROUND AND OBJECTIVE: Psoriatic arthritis (PsA) is a chronic systemic inflammatory disease affecting the musculoskeletal system, skin and nails. The aim is to characterize sociodemographic and … clinical patient profiles documented in dermatologic and rheumatologic care. PATIENTS AND METHODS: Data of 704 patients with PsA from the dermatological Psoriasis Registry PsoBest (PB) and 1066 patients from the rheumatological disease registry RABBIT-SpA (RS) were analyzed. Comparable anamnestic and clinical variables were identified and descriptively analyzed. RESULTS: The mean age was 51.7 years in PB and 51.9 in RS. Disease duration of psoriasis was longer, mean cutaneous severity was higher in PB. However, more patients in RS vs. PB had tender joints and swollen joints. Mean Dermatology Life Quality Index was higher in PB and mean Health Assessment Questionnaire in RS. Patient reported global disease activity and pain were lower in PB. IL-23 inhibitors were used more frequently in PB, and TNF inhibitors in RS. CONCLUSIONS: Clinical specialization was associated with different clinical and treatment patterns of PsA. This may indicate a selection by dominant manifestation of psoriatic disease and potentially by effects of health care access. Psoriatic arthritis should be treated in a multidisciplinary approach considering all facets of this complex disease.

Authors: M. Augustin, L. Lindner, L. Kuhl, A. Weiss, S. J. Rustenbach, B. Stephan, M. Feuchtenberger, U. Mrowietz, D. Thaci, P. Staubach, X. Baraliakos, A. Strangfeld, R. von Kiedrowski, F. Behrens, A. C. Regierer

Date Published: 2023

Publication Type: Journal

[Charakterisierung von Patienten mit Psoriasisarthritis in der dermatologischen und rheumatologischen Versorgung: Analyse von zwei Registern: Characterization of patients with psoriatic arthritis in dermatologic and rheumatologic care: analysis of two registries]

Abstract

Not specified

Authors: M. Augustin, L. Lindner, L. Kuhl, A. Weiss, S. J. Rustenbach, B. Stephan, M. Feuchtenberger, U. Mrowietz, D. Thaci, P. Staubach, X. Baraliakos, A. Strangfeld, R. von Kiedrowski, F. Behrens, A. C. Regierer

Date Published: 2023

Publication Type: Journal

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