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1. Persistence of seroconversion at 6 months following primary immunisation in patients with immune-mediated inflammatory diseases

Author

Wieske, L., Stalman, E.W., Dam, P.J.K. van, Kummer, L.Y., Steenhuis, M., Kempen, Z.L.E. van, Killestein, J., Volkers, A.G., Tas, S.W., Boekel, L., Wolbink, G., Kooi, A. van der, Raaphorst, J., Lowenberg, M., Takkenberg, B., D'Haens, G.R.A.M., Spuls, P.I., Bekkenk, M.W., Musters, A.H., Post, N.F., Bosma, A.L., Hilhorst, M.L., Vegting, Y., Bemelman, F.J., Voskuyl, A., Broens, B., Sanchez, A.P., Els, C.A.C.M. van, Wit, J. de, Rutgers, A., Leeuw, K. de, Horvath, B., Verschuuren, J.J.G.M., Ruiter, A.M., Ouwerkerk, L. van, Woude, D. van der, Allaart, C.F., Teng, Y.K.O., Paassen, P. van, Busch, M.H., Jallah, P.B.P., Brusse, E., Doorn, P.A. van, Baars, A.E., Hijnen, D., Schreurs, C.R.G., Pol, W.L. van der, Goedee, H.S., Keijzer, S., Keijser, J., Cristianawati, O., Brinke, A. ten, Verstegen, N.J.M., Zwinderman, K.A.H., Ham, S.M. van, Kuijpers, T.W., Rispens, T., Eftimov, F., T2B Immunity SARS CoV 2 Study Grp, Interne Geneeskunde, MUMC+: MA Nefrologie (9), MUMC+: MA Klinische Immunologie (9), RS: Carim - B02 Vascular aspects thrombosis and Haemostasis, Neurology, Amsterdam Neuroscience - Neuroinfection & -inflammation, AII - Inflammatory diseases, Rheumatology, Dermatology, Nephrology, and AII - Infectious diseases

Subjects
Rheumatology, SDG 3 - Good Health and Well-being, Immunology, Vaccination, Immunology and Allergy, Tumor Necrosis Factor Inhibitors, Covid-19, General Biochemistry, Genetics and Molecular Biology, Autoimmune Diseases
Abstract

Patients with immune-mediated inflammatory diseases (IMIDs) may have impaired initial humoral responses after SARS-CoV-2 vaccination depending on the type of immunosuppression (ISP) used.1 It is largely unknown how antibody titres develop over time and whether it is needed to adjust timing of booster campaigns for patients with IMID.

Published
2023
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2. Primary SARS-CoV-2 infection in patients with immune-mediated inflammatory diseases

Author

Dam, K.P.J. van, Volkers, A.G., Wieske, L., Stalman, E.W., Kummer, L.Y.L., Kempen, Z.L.E. van, Killestein, J., Tas, S.W., Boekel, L., Wolbink, G.J., Kooi, A.J. van der, Raaphorst, J., Takkenberg, R.B., D'Haens, G.R.A.M.I., Spuls, P.W., Bekkenk, M.H., Musters, A.F., Post, N.L., Bosma, A.L., Hilhorst, M., Vegting, Y.J., Bemelman, F.E., Voskuyl, A., Broens, B., Sanchez, A.P., Els, C.A.C.M. van, Wit, J. de, Rutgers, A., Leeuw, K. de, Horvath, B., Verschuuren, J.J.G.M.M., Ruiter, A.M., Ouwerkerk, L. van, Woude, D. van der, Allaart, R.C.F., Teng, Y.K.O., Paassen, P.H. van, Busch, M.H., Jallah, P.B.P., Brusse, E., Doorn, P.A. van, Baars, A.E., Hijnen, D.J., Schreurs, C.R.G., Pol, W.L. van der, Goedee, H.S., Steenhuis, M., Keijzer, S., Keijser, J.B.D., Cristianawati, O., Brinke, A. ten, Verstegen, N.J.M., Ham, S.M. van, Rispens, T.W., Kuijpers, T., Lowenberg, M., Eftimov, F., and TB2 Immunity Sars-Cov-2 Study Grp

Subjects
Immune-mediated inflammatory diseases, SARS-CoV-2, Autoimmune disease, TNF, Immunity, Disease activity, Covid-19, Immunosuppression, Antibodies, Flare
Abstract

Background: Patients with immune-mediated inflammatory diseases (IMIDs) on immunosuppressants (ISPs) may have impaired long-term humoral immune responses and increased disease activity after SARS-CoV-2 infection. We aimed to investigate long-term humoral immune responses against SARS-CoV-2 and increased disease activity after a primary SARS-CoV-2 infection in unvaccinated IMID patients on ISPs. Methods: IMID patients on active treatment with ISPs and controls (i.e. IMID patients not on ISP and healthy controls) with a confirmed SARS-CoV-2 infection before first vaccination were included from an ongoing prospective cohort study (T2B! study). Clinical data on infections and increased disease activity were registered using electronic surveys and health records. A serum sample was collected before first vaccination to measure SARS-CoV-2 anti-receptor-binding domain (RBD) antibodies. Results: In total, 193 IMID patients on ISP and 113 controls were included. Serum samples from 185 participants were available, with a median time of 173 days between infection and sample collection. The rate of seropositive IMID patients on ISPs was 78% compared to 100% in controls (p < 0.001). Seropositivity rates were lowest in patients on anti-CD20 (40.0%) and anti-tumor necrosis factor (TNF) agents (60.5%), as compared to other ISPs (p < 0.001 and p < 0.001, respectively). Increased disease activity after infection was reported by 68 of 260 patients (26.2%; 95% CI 21.2-31.8%), leading to ISP intensification in 6 out of these 68 patients (8.8%). Conclusion: IMID patients using ISPs showed reduced long-term humoral immune responses after primary SARS-CoV-2 infection, which was mainly attributed to treatment with anti-CD20 and anti-TNF agents. Increased disease activity after SARS-CoV-2 infection was reported commonly, but was mostly mild.

Published
2023

3. Breakthrough infections with the SARS-CoV-2 omicron (B.1.1.529) variant in patients with immune-mediated inflammatory diseases

Author

Stalman, E.W., Wieske, L., Dam, K.P.J. van, Kummer, L.Y., Kempen, Z.L.E. van, Killestein, J., Volkers, A.G., Tas, S.W., Boekel, L., Wolbink, G.J., Kooi, A.J. van der, Raaphorst, J., Lowenberg, M., Takkenberg, R.B., D'Haens, G.R.A.M., Spuls, P.I., Bekkenk, M.W., Musters, A.H., Post, N.F., Bosma, A.L., Hilhorst, M.L., Vegting, Y., Bemelman, F.J., Voskuyl, A.E., Broens, B., Sanchez, A.P., Els, C.A.C.M. van, Wit, J. de, Rutgers, A., Leeuw, K. de, Horvath, B., Verschuuren, J.J.G.M., Ruiter, A.M., Ouwerkerk, L. van, Woude, D. van der, Allaart, C.F., Teng, O.Y.K., Paassen, P. van, Busch, M.H., Jallah, P.B.P., Brusse, E., Doorn, P.A. van, Baars, A.E., Hijnen, D.J., Schreurs, C.R.G., Pol, W.L. van der, Goedee, H.S., Steenhuis, M., Keijzer, S., Keijser, J.B.D., Boogaard, A., Cristianawati, O., Brinke, A. ten, Verstegen, N.J.M., Zwinderman, K.A.H., Rispens, T., Ham, S.M. van, Kuijpers, T.W., Eftimov, F., T2B Immunity Against SARS Co, Neurology, Dermatology, Graduate School, Paediatrics, Gastroenterology and Hepatology, Experimental Immunology, Clinical Immunology and Rheumatology, AII - Inflammatory diseases, Landsteiner Laboratory, ANS - Neuroinfection & -inflammation, ANS - Neurodegeneration, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, APH - Methodology, APH - Quality of Care, AII - Cancer immunology, Nephrology, 01 Internal and external specialisms, ACS - Atherosclerosis & ischemic syndromes, Epidemiology and Data Science, Paediatric Infectious Diseases / Rheumatology / Immunology, ARD - Amsterdam Reproduction and Development, EURO-NMD, Translational Immunology Groningen (TRIGR), SILS Other Research (FNWI), Amsterdam Neuroscience - Neuroinfection & -inflammation, Rheumatology, Molecular cell biology and Immunology, Pediatrics, Interne Geneeskunde, MUMC+: MA Nefrologie (9), MUMC+: MA Klinische Immunologie (9), RS: Carim - B02 Vascular aspects thrombosis and Haemostasis, and MUMC+: MA Med Staf Artsass Interne Geneeskunde (9)

Subjects
COVID-19 Vaccines, SARS-CoV-2, Immunology, Vaccination, Autoimmunity, General Biochemistry, Genetics and Molecular Biology, Autoimmune Diseases, Cohort Studies, Rheumatology, SDG 3 - Good Health and Well-being, Immunology and Allergy, Humans, Prospective Studies, Covid-19, Immunosuppressive Agents
Abstract

ObjectivesTo compare the cumulative incidence and disease severity of reported SARS-CoV-2 omicron breakthrough infections between patients with immune-mediated inflammatory diseases (IMID) on immunosuppressants and controls, and to investigate determinants for breakthrough infections.MethodsData were used from an ongoing national prospective multicentre cohort study on SARS-CoV-2 vaccination responses in patients with IMID in the Netherlands (Target-to-B! (T2B!) study). Patients wih IMID on immunosuppressants and controls (patients with IMID not on immunosuppressants and healthy controls) who completed primary immunisation were included. The observation period was between 1 January 2022 and 1 April 2022, during which the SARS-CoV-2 omicron (BA.1 and BA.2 subvariant) was dominant. A SARS-CoV-2 breakthrough infection was defined as a reported positive PCR and/or antigen test at least 14 days after primary immunisation. A multivariate logistic regression model was used to investigate determinants.Results1593 patients with IMID on immunosuppressants and 579 controls were included. The cumulative incidence of breakthrough infections was 472/1593 (29.6%; 95% CI 27% to 32%) in patients with IMID on immunosuppressants and 181/579 (31.3%; 95% CI 28% to 35%) in controls (p=0.42). Three (0.5%) participants had severe disease. Seroconversion after primary immunisation (relative risk, RR 0.71; 95% CI 0.52 to 0.96), additional vaccinations (RR 0.61; 95% CI 0.49 to 0.76) and a prior SARS-CoV-2 infection (RR 0.60; 95% CI 0.48 to 0.75) were associated with decreased risk of breakthrough infection.ConclusionsThe cumulative incidence of reported SARS-CoV-2 omicron breakthrough infections was high, but similar between patients with IMID on immunosuppressants and controls, and disease severity was mostly mild. Additional vaccinations and prior SARS-CoV-2 infections may reduce the incidence of breakthrough infections.

Published
2022
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4. Breakthrough SARS-CoV-2 infections with the delta (B.1.617.2) variant in vaccinated patients with immune-mediated inflammatory diseases using immunosuppressants: a substudy of two prospective cohort studies

Author

Boekel, L., Stalman, E.W., Wieske, L., Hooijberg, F., Dam, K.P.J. van, Besten, Y.R., Kummer, L.Y., Steenhuis, M., Kempen, Z.L.E. van, Killestein, J., Volkers, A.G., Tas, S.W., Kooi, A.J. van der, Raaphorst, J., Löwenberg, M., Takkenberg, R.B., d'Haens, G., Spuls, P.I., Bekkenk, M.W., Musters, A.H., Post, N.F., Bosma, A.L., Hilhorst, M.L., Vegting, Y., Bemelman, F.J., Voskuyl, A.E., Broens, B., Sanchez, A., Els, C. van, Wit, J. de, Rutgers, A., Leeuw, K. de, Horváth, B., Verschuuren, J., Ruiter, A.M. de, Ouwerkerk, L., Woude, D. van der, Allaart, C.F., Teng, Y.K.O., Paassen, P. van, Busch, M.H., Jallah, P.B.P., Brusse, E., Doorn, P.A. van, Baars, A.E., Hijnen, D.J., Schreurs, C.R.G., Pol, W.Ludo van der, Goedee, H.S., Vogelzang, E.H., Leeuw, M. de, Atiqi, S., Vollenhoven, R. van, Gerritsen, M, Horst-Bruinsma, I.E. van der, Lems, W.F., Nurmohamed, M.T., Boers, Maarten, Keijzer, Sofie, Keijser, J. de, Sandt, C., Boogaard, A., Cristianawati, O., Brinke, A. Ten, Verstegen, N.J., Zwinderman, K.A.H., Ham, S.M. van, Rispens, T., Kuijpers, T.W., Wolbink, G., Eftimov, F., Boekel, L., Stalman, E.W., Wieske, L., Hooijberg, F., Dam, K.P.J. van, Besten, Y.R., Kummer, L.Y., Steenhuis, M., Kempen, Z.L.E. van, Killestein, J., Volkers, A.G., Tas, S.W., Kooi, A.J. van der, Raaphorst, J., Löwenberg, M., Takkenberg, R.B., d'Haens, G., Spuls, P.I., Bekkenk, M.W., Musters, A.H., Post, N.F., Bosma, A.L., Hilhorst, M.L., Vegting, Y., Bemelman, F.J., Voskuyl, A.E., Broens, B., Sanchez, A., Els, C. van, Wit, J. de, Rutgers, A., Leeuw, K. de, Horváth, B., Verschuuren, J., Ruiter, A.M. de, Ouwerkerk, L., Woude, D. van der, Allaart, C.F., Teng, Y.K.O., Paassen, P. van, Busch, M.H., Jallah, P.B.P., Brusse, E., Doorn, P.A. van, Baars, A.E., Hijnen, D.J., Schreurs, C.R.G., Pol, W.Ludo van der, Goedee, H.S., Vogelzang, E.H., Leeuw, M. de, Atiqi, S., Vollenhoven, R. van, Gerritsen, M, Horst-Bruinsma, I.E. van der, Lems, W.F., Nurmohamed, M.T., Boers, Maarten, Keijzer, Sofie, Keijser, J. de, Sandt, C., Boogaard, A., Cristianawati, O., Brinke, A. Ten, Verstegen, N.J., Zwinderman, K.A.H., Ham, S.M. van, Rispens, T., Kuijpers, T.W., Wolbink, G., and Eftimov, F.

Abstract

Item does not contain fulltext, BACKGROUND: Concerns have been raised regarding the risks of SARS-CoV-2 breakthrough infections in vaccinated patients with immune-mediated inflammatory diseases treated with immunosuppressants, but clinical data on breakthrough infections are still scarce. The primary objective of this study was to compare the incidence and severity of SARS-CoV-2 breakthrough infections between patients with immune-mediated inflammatory diseases using immunosuppressants, and controls (patients with immune-mediated inflammatory diseases not taking immunosuppressants and healthy controls) who had received full COVID-19 vaccinations. The secondary objective was to explore determinants of breakthrough infections of the delta (B.1.617.2) variant of SARS-CoV-2, including humoral immune responses after vaccination. METHODS: In this substudy, we pooled data collected in two large ongoing prospective multicentre cohort studies conducted in the Netherlands (Target to-B! [T2B!] study and Amsterdam Rheumatology Center COVID [ARC-COVID] study). Both studies recruited adult patients (age ≥18 years) with immune-mediated inflammatory diseases and healthy controls. We sourced clinical data from standardised electronic case record forms, digital questionnaires, and medical files. We only included individuals who were vaccinated against SARS-CoV-2. For T2B!, participants were recruited between Feb 2 and Aug 1, 2021, and for ARC-COVID, participants were recruited between April 26, 2020, and March 1, 2021. In this study we assessed data on breakthrough infections collected between July 1 and Dec 15, 2021, a period in which the delta SARS-CoV-2 variant was the dominant variant in the Netherlands. We defined a SARS-CoV-2 breakthrough infection as a PCR-confirmed or antigen test-confirmed SARS-CoV-2 infection that occurred at least 14 days after vaccination. All breakthrough infections during this period were assumed to be due to the delta variant due to its dominance during the study period. We analysed

Published
2022

6. Long-term effectiveness and safety of treatment with dupilumab in patients with atopic dermatitis: Results of the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry

Author

Bosma, A.L. (Angela L.), de Wijs, L.E.M. (Linde E.M.), Hof, M.H. (Michel H.), van Nieuwenhuizen, B.R. (Beau R.), Gerbens, L.A.A. (Louise A.A.), Middelkamp-Hup, M.A. (M.), Hijnen, D.-J. (Dirk-Jan), Spuls, P.I. (Phyllis), Bosma, A.L. (Angela L.), de Wijs, L.E.M. (Linde E.M.), Hof, M.H. (Michel H.), van Nieuwenhuizen, B.R. (Beau R.), Gerbens, L.A.A. (Louise A.A.), Middelkamp-Hup, M.A. (M.), Hijnen, D.-J. (Dirk-Jan), and Spuls, P.I. (Phyllis)

Abstract

Background: Evidence on long-term dupilumab treatment for atopic dermatitis in daily practice is lacking. Objective: To investigate patient characteristics, treatment aspects, effectiveness, and safety of up to 84 weeks of dupilumab treatment. Methods: An observational prospective cohort study was conducted of patients with atopic dermatitis starting dupilumab in routine clinical care. Results: Of the 221 included patients, 103 used systemic therapy at baseline. At 84 weeks, we found a change of −15.2 (SE, 1.7) for the Eczema Area and Severity Index, −16.9 (SE, 1.4) for the Patient-Oriented Eczema Measure, and −17.2 (SE, 1.6) for the Dermatology Life Quality Index. We found a trend for improvement over time for the Investigator Global Assessment and Numerical Rating Scale for pruritus. Severe (n = 79) including serious (n = 11) adverse events were observed in 69 patients. Eye complaints were most frequently reported (n = 46). Twenty-one patients adjusted the regular dosing schedule, and 14 patients discontinued treatment, mainly due to ineffectiveness (n = 7). Limitations: Only adverse events of severe and serious nature were registered for feasibility reasons. Conclusion: Daily practice dupilumab treatment of up to 84 weeks is generally well-tolerated, apart from the reporting of eye complaints. It can be considered a long-term effective treatment for atopic dermatitis in combination with topical and initial concomitant systemic treatment, showing a sustained improvement of signs, symptoms, and quality of life.

Published
2020
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7. TREatment of ATopic eczema (TREAT) Registry Taskforce: method for comparing the safety of dupilumab with other systemic therapies for moderate‐to‐severe eczema

Author

Bosma, A.L., primary, Spuls, P.I., additional, Garcia‐Doval, I., additional, Naldi, L., additional, Prieto‐Merino, D., additional, Tesch, F., additional, Apfelbacher, C.J., additional, Arents, B.W.M., additional, Barbarot, S., additional, Baselga, E., additional, Deleuran, M., additional, Eichenfield, L.F., additional, Gerbens, L.A.A., additional, Irvine, A.D., additional, Manca, A., additional, Mendes‐Bastos, P., additional, Middelkamp‐Hup, M.A., additional, Roberts, A., additional, Seneschal, J., additional, Svensson, Å., additional, Thyssen, J.P., additional, Torres, T., additional, Vermeulen, F.M., additional, Vestergaard, C., additional, Kobyletzki, L.B., additional, Wall, D., additional, Weidinger, S., additional, Schmitt, J., additional, and Flohr, C., additional

Published
2020
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8. 特应性湿疹的治疗 (TREAT) 登记工作组:比较 Dupilumab 与其他全身药物治疗中度至重度湿疹安全性的方法

Author

Bosma, A.L., primary, Spuls, P.I., additional, Garcia‐Doval, I., additional, Naldi, L., additional, Prieto‐Merino, D., additional, Tesch, F., additional, Apfelbacher, C.J., additional, Arents, B.W.M., additional, Barbarot, S., additional, Baselga, E., additional, Deleuran, M., additional, Eichenfield, L.F., additional, Gerbens, L.A.A., additional, Irvine, A.D., additional, Manca, A., additional, Mendes‐Bastos, P., additional, Middelkamp‐Hup, M.A., additional, Roberts, A., additional, Seneschal, J., additional, Svensson, Å., additional, Thyssen, J.P., additional, Torres, T., additional, Vermeulen, F.M., additional, Vestergaard, C., additional, Kobyletzki, L.B., additional, Wall, D., additional, Weidinger, S., additional, Schmit, J., additional, and Flohr, C., additional

Published
2020
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11. The BIOMarkers in Atopic Dermatitis and Psoriasis (BIOMAP) glossary: developing a lingua franca to facilitate data harmonization and cross‐cohort analyses.

Author

Broderick, C., Christian, N., Apfelbacher, C., Bosma, A.L., Dand, N., Ghosh, S., Hangel, N., Hübenthal, M., Middelkamp‐Hup, M.A., Min, J.L., Musters, A.H., Paternoster, L., Rodríguez, E., Satagopam, V., Scordis, P., Spuls, P.I., Szymczak, S., Weidinger, S., Smith, C.H., and Flohr, C.

Subjects
DATA harmonization, ATOPIC dermatitis, PSORIATIC arthritis, GLOSSES & glossaries, PSORIASIS, BIOMARKERS, ECZEMA
Abstract

Iterative discussions between each dataset custodian and the harmonization bioinformaticians culminate with a dataset-specific mapping document specifying how individual variables will be transformed to the glossary-defined dataset, thus ensuring accurately harmonized data (step 4). Dear Editor, The BIOMarkers in Atopic dermatitis and Psoriasis (BIOMAP) is a large European consortium aiming to advance personalized medicine for atopic dermatitis and psoriasis by identifying biomarkers that predict therapeutic response and disease progression. The BIOMarkers in Atopic Dermatitis and Psoriasis (BIOMAP) glossary: developing a lingua franca to facilitate data harmonization and cross-cohort analyses. [Extracted from the article]

Published
2021
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12. TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema

Author

Bosma, A.L., primary, Spuls, P.I., additional, Garcia‐Doval, I., additional, Naldi, L., additional, Prieto‐Merino, D., additional, Tesch, F., additional, Apfelbacher, C.J., additional, Arents, B.W.M., additional, Barbarot, S., additional, Baselga, E., additional, Deleuran, M., additional, Eichenfield, L.F., additional, Gerbens, L.A.A., additional, Irvine, A.D., additional, Manca, A., additional, Mendes‐Bastos, P., additional, Middelkamp‐Hup, M.A., additional, Roberts, A., additional, Seneschal, J., additional, Svensson, Å., additional, Thyssen, J.P., additional, Torres, T., additional, Vermeulen, F.M., additional, Vestergaard, C., additional, Kobyletzki, L.B., additional, Wall, D., additional, Weidinger, S., additional, Schmitt, J., additional, and Flohr, C., additional

Published
2019
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14. TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema.

Author

Bosma, A.L., Spuls, P.I., Garcia‐Doval, I., Naldi, L., Prieto‐Merino, D., Tesch, F., Apfelbacher, C.J., Arents, B.W.M., Barbarot, S., Baselga, E., Deleuran, M., Eichenfield, L.F., Gerbens, L.A.A., Irvine, A.D., Manca, A., Mendes‐Bastos, P., Middelkamp‐Hup, M.A., Roberts, A., Seneschal, J., and Svensson, Å.

Subjects
*ATOPIC dermatitis, *SKIN cancer, *LICENSE agreements, *SPECIAL events, *ADVERSE health care events, *LONGITUDINAL method
Abstract

Summary: Background: A long‐term prospective observational safety study is essential to characterize fully the safety profile of systemic immunomodulating therapies for patients with atopic eczema. The TREatment of ATopic eczema (TREAT) Registry Taskforce offers a large platform to conduct such research using national registries that collect the same data using a predefined core dataset. Objectives: To present a protocol for a safety study comparing dupilumab with other systemic immunomodulating therapies in children and adults with moderate‐to‐severe atopic eczema, to assess the long‐term safety risk of these therapies in a routine clinical care setting. Methods: We describe a registry‐embedded international observational prospective cohort study. Adult and paediatric patients who start treatment with dupilumab or another systemic immunomodulating agent for their atopic eczema will be included. The primary end point is the incidence of malignancies (excluding nonmelanoma skin cancer) compared between the treatment groups. Secondary end points include other serious adverse events and adverse events of special interest, such as eye disorders and eosinophilia. Conclusions: This protocol delineates a safety study for dupilumab in adult and paediatric patients with atopic eczema, using a standardized methodological approach across several national registries. The protocol could also be used for other novel systemic immunomodulating therapies, and could provide licensing and reimbursement authorities, pharmaceutical companies and clinicians with safety evidence from a routine clinical care setting. What's already known about this topic? There is a need for long‐term data on the safety of systemic immunomodulating therapies in patients with atopic eczema.Regulatory bodies, such as the European Medicines Agency, increasingly stipulate the collection of such data as part of the licensing agreement for new treatments, to assess the new agent's long‐term safety profile against established therapies.Large numbers of patients with a long duration of follow‐up are necessary in order to detect rare events like malignancies. What does this study add? The TREAT Registry Taskforce offers a platform to conduct such research with a network of multiple national atopic eczema research registries.We present a protocol for an investigator‐initiated multicentre safety study comparing dupilumab with other systemic immunomodulating therapies in adults and subsequently adolescents and children with moderate‐to‐severe atopic eczema.This protocol can be used as a framework for similar studies for other novel systemic immunomodulating therapies across both adult and paediatric populations. Plain language summary available online [ABSTRACT FROM AUTHOR]

Published
2020
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15. TREatment of ATopic eczema (TREAT) Registry Taskforce: consensus on how and when to measure the core dataset for atopic eczema treatment research registries.

Author

Vermeulen, F.M., Gerbens, L.A.A., Bosma, A.L., Apfelbacher, C.J., Irvine, A.D., Arents, B.W.M., Barbarot, S., Deleuran, M., Eichenfield, L.F., Manca, A., Schmitt, J., Vestergaard, C., Wall, D., Weidinger, S., Middelkamp‐Hup, M.A., Spuls, P.I., and Flohr, C.

Subjects
ATOPIC dermatitis, MEDICAL registries, ACQUISITION of data
Abstract

Summary: Background: Comparative, real‐life and long‐term evidence on the effectiveness and safety of phototherapy and systemic therapy in moderate‐to‐severe atopic eczema (AE) is limited. Such data must come from well‐designed prospective patient registries. Standardization of data collection is needed for direct comparisons and data pooling. Objectives: To reach a consensus on how and when to measure the previously defined domain items of the TREatment of ATopic eczema (TREAT) Registry Taskforce core dataset for research registries for paediatric and adult patients with AE. Methods: Proposals for the measurement instruments were based on recommendations of the Harmonising Outcome Measures for Eczema (HOME) initiative, the existing AE database of TREATgermany, systematic reviews of the literature and expert opinions. The proposals were discussed at three face‐to‐face consensus meetings, one teleconference and via e‐mail. The frequency of follow‐up visits was determined by an expert survey. Results: A total of 16 experts from seven countries participated in the 'how to measure' consensus process and 12 external experts were consulted. A consensus was reached for all domain items on how they should be measured by assigning measurement instruments. A minimum follow‐up frequency of initially 4 weeks after commencing treatment, then every 3 months while on treatment and every 6 months while off treatment was defined. Conclusions: This core dataset for national AE research registries will aid in the comparability and pooling of data across centres and country borders, and enables international collaboration to assess the long‐term effectiveness and safety of phototherapy and systemic therapy used in patients with AE. What's already known about this topic? Comparable, real‐life and long‐term data on the effectiveness and safety of phototherapy and systemic therapy in patients with atopic eczema (AE) are needed.There is a high diversity of outcomes and instruments used in AE research, which require harmonization to enhance comparability and allow data pooling. What does this study add? Our taskforce has reached international consensus on how and when to measure core domain items for national AE research registries.This core dataset is now available for use by researchers worldwide and will aid in the collection of unified data. What are the clinical implications of this work? The data collected through this core dataset will help to gain better insights into the long‐term effectiveness and safety of phototherapy and systemic therapy in AE and will provide important information for clinical practice.Standardization of such data collection at the national level will also allow direct data comparisons and pooling across country borders (e.g. in the analysis of treatment‐related adverse events that require large patient numbers). Plain language summary available online Respond to this article [ABSTRACT FROM AUTHOR]

Published
2019
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16. Consensus on measurement of core dataset for AE treatment research registries.

Author

Vermeulen, F.M., Gerbens, L.A.A., Bosma, A.L., Apfelbacher, C.J., Irvine, A.D., Arents, B.W.M., Barbarot, S., Deleuran, M., Eichenfield, L.F., Manca, A., Schmitt, J., Vestergaard, C., Wall, D., Weidinger, S., Middelkamp‐Hup, M.A., Spuls, P.I., and Flohr, C.

Subjects
ATOPIC dermatitis, ECZEMA, TREATMENT effectiveness, ACQUISITION of data, DRUG side effects
Abstract

Summary: Moderate‐to‐severe atopic eczema (AE) is often treated with phototherapy (light treatment) or systemic therapy (medication that works throughout the whole body). Long‐term data on effectiveness and safety of these treatments is currently missing. To address this issue, data on paediatric and adult patients who use or used these treatments in a real‐life setting should be collected in national research registries. Ideally, these national registries should be compatible, so that data can be combined and analysed from as many patients as possible (which is needed to find rare side‐effects, for example). Therefore, every country needs to collect the same data in the same way. For this purpose the international TREatment of ATopic eczema (TREAT) Registry Taskforce has been established. It has already standardised which items need to be measured (e.g. disease severity, side effects). This study addresses the two remaining issues: how and when to measure these items. To determine how to measure the items (i.e. which measurement instruments to use), the authors used the recommendations from the Harmonising Outcome Measures for Eczema (HOME) initiative, relevant literature (published scientific studies), an already existing AE registry in Germany, and expert opinions. The proposals were discussed at multiple meetings and via email. This resulted in agreement (consensus) on how to measure the already standardised item‐set. The issue of when to measure the items, the follow‐up frequency, was resolved with an online survey. Consensus was reached on a minimum follow‐up frequency of 4 weeks after starting treatment, then every 3 months whilst on treatment and every 6 months whilst off treatment. A complete core dataset is now available that will help with the standardised collection of data of paediatric and adult AE patients on photo‐ and systemic therapies. This will help, in time, answer questions on the long‐term effectiveness and safety of these treatments and improve care for moderate‐to‐severe AE patients. Linked Article: Vermeulen et al. Br J Dermatol 2019; 181:492–504 [ABSTRACT FROM AUTHOR]

Published
2019
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17. 关于 AE 治疗研究注册核心数据集测量的共识.

Author

Vermeulen, F.M., Gerbens, L.A.A., Bosma, A.L., Apfelbacher, C.J., Irvine, A.D., Arents, B.W.M., Barbarot, S., Deleuran, M., Eichenfield, L.F., Manca, A., Schmitt, J., Vestergaard, C., Wall, D., Weidinger, S., Middelkamp‐Hup, M.A., Spuls, P.I., and Flohr, C.

Subjects
DWELLINGS
Abstract

Summary: 中重度特应性湿疹 (AE) 常通过光疗(光线治疗)或全身治疗(通过全身发挥作用的药物)来治疗。目前尚无关于这些治疗有效性和安全性的长期数据。为了解决这一问题,应在国家研究注册中收集正在现实生活环境中或曾经在此环境中使用这些治疗的儿童和成人患者的相关数据。理想情况下,这些国家注册应是可以相容的,从而可以合并尽可能多的患者数据,并加以分析(举例而言,这对于发现罕见副作用是必须的)。因此,所有国家都需要以相同方式收集相同的数据。为此,建立了国际特应性湿疹治疗 (TREAT) 注册任务组。它已经标准化了需要测量的项目(例如疾病严重程度、副作用)。这项研究解决了两个剩余问题:如何和何时测量这些项目。为了确定如何测量这些项目(即,使用何种测量工具),作者们使用了来自湿疹结局测量一致化 (HOME) 行动中的推荐意见、相关文献(已发表的科学研究)、德国已有的 AE 注册和专家意见。在多次会议上和通过电子邮件讨论了这些提案。这导致就如何测量已标准化的项目集达成了一致(共识)。通过在线调查解决了何时测量这些项目的问题(随访频率)。就开始治疗后 4 周,后续治疗中每 3 个月一次,停止治疗后每 6 个月一次的最低随访频率达成了共识。完整核心数据集线现已可用,将帮助标准化儿童和成人 AE 患者光疗和全身治疗数据的采集。这将有助于及时回答这些治疗长期有效性和安全性的问题,并改善中重度 AE 患者的治疗。 Linked Article: Vermeulen et al. Br J Dermatol 2019; 181:492–504 [ABSTRACT FROM AUTHOR]

Published
2019
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