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001-es BibID:	BIBFORM117961
035-os BibID:	(cikkazonosító)27 (scopus)85182418710 (wos)001144630300003
Első szerző:	Aggarwal, Rohit
Cím:	Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis : results from the randomised, placebo-controlled ProDERM study / Aggarwal Rohit, Schessl Joachim, Charles-Schoeman Christina, Bata-Csörgő Zsuzsanna, Dimachkie Mazen M., Griger Zoltan, Moiseev Sergey, Oddis Chester V., Schiopu Elena, Vencovsky Jiri, Beckmann Irene, Clodi Elisabeth, Levine Todd, ProDERM investigators
Dátum:	2024
ISSN:	1478-6354 1478-6362
Megjegyzések:	Abstract Introduction: Dermatomyositis (DM) is an inflammatory myopathy characterized by distinct skin manifestations and muscle weakness. Intravenous immunoglobulin (IVIg) has been used off-label as adjuvant therapy in DM, but is not indicated for DM, due to lack of proven efficacy in a large randomized controlled trial. The objective of the ProDERM (Progress in DERMatomyositis) study was to evaluate the efficacy, safety and long-term tolerability of IVIg (Octagam 10%) in patients with DM in a randomized, placebo-controlled, double-blind, Phase III study. Methods: Adult patients with active DM who were continuing standard therapy at a stable dose were eligible for this study. Patients were randomized 1:1 to receive either 2 g/kg of IVIg or placebo, administered every 4 weeks until week 16 (First Period). Patients were switched to the alternate treatment if they showed clinical deterioration in the First Period. After response assessment at week 16, all patients on placebo and those without deterioration on IVIg entered the open-label Extension Period, receiving 2 g/kg IVIg every 4 weeks for 24 weeks. Results: The primary efficacy endpoint was the proportion of responders in the IVIg vs placebo arm at week 16, where response was defined per 2016 ACR/EULAR Myositis Response Criteria of at least minimal improvement [Total Improvement Score (TIS) ?20] and without deterioration at 2 consecutive visits up to week 16. TIS consists of composite response criteria, combining weighted improvement in 6 core set measures (CSMs), Global Disease Activity (Physician and Patient), manual muscle testing-8 (MMT-8), Health Assessment Questionnaire, extra-muscular disease activity, and muscle enzymes. Secondary endpoints included the mean change in individual CSMs, time to improvement in TIS, time to confirmed deterioration in the First Period, and the overall proportion of patients with deteriorations. Adverse events, including infusion reactions and thromboembolic events, were recorded. Conclusions: The ProDERM study was the first to assess the long-term efficacy and safety of IVIg (Octagam 10%) in a placebo-controlled, blinded, randomized trial in DM. The study aimed to inform on the use of IVIg in the treatment of DM, and results are expected in Q3 2020.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Dermatomyositis Intravenous immunoglobulin Myositis Safety Tolerability
Megjelenés:	Arthritis Research & Therapy. - 26 : 1 (2024), p. 1-13. -
További szerzők:	Schessl, Joachim Charles-Schoeman, Christina Bata-Csörgő Zsuzsanna Dimachkie, Mazen M. Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Moiseev, Sergey Oddis, Chester V. Schiopu, Elena Vencovsky, Jiri Beckmann, Irene Clodi, Elisabeth Levine, Todd ProDERM Trial Group
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001-es BibID:	BIBFORM103936
035-os BibID:	(WoS)000868254300009 (Scopus)85143055930
Első szerző:	Aggarwal, Rohit
Cím:	Trial of Intravenous Immune Globulin in Dermatomyositis / Aggarwal Rohit, Charles-Schoeman Christina, Schessl Joachim, Bata-Csörgő Zsuzsanna, Dimachkie Mazen M., Griger Zoltan, Moiseev Sergey, Oddis Chester, Schiopu Elena, Vencovsky Jiri, Beckmann Irene, Clodi Elisabeth, Bugrova Olga, Dankó Katalin, Ernste Floranne, Goyal Namita A., Heuer Marvin, Hudson Marie, Hussain Yessar M., Karam Chafic, Magnolo Nina, Nelson Ronald, Pozur Nataliia, Prystupa Liudmyla, Sárdy Miklós, Valenzuela Guillermo, van der Kooi Anneke J., Vu Tuan, Worm Margitta, Levine Todd, ProDERM Trial Group
Dátum:	2022
ISSN:	0028-4793
Megjegyzések:	Background: Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated. Methods: We conducted a randomized, placebo-controlled trial involving patients with active dermatomyositis. The patients were assigned in a 1:1 ratio to receive IVIG at a dose of 2.0 g per kilogram of body weight or placebo every 4 weeks for 16 weeks. The patients who received placebo and those without confirmed clinical deterioration while receiving IVIG could enter an open-label extension phase for another 24 weeks. The primary end point was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score reflecting the change in a core set of six measures of myositis activity over time; scores range from 0 to 100, with higher scores indicating greater improvement. Key secondary end points included at least moderate improvement (TIS ?40) and major improvement (TIS ?60), and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index. Results: A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events. Conclusions: In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.).
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	New England Journal Of Medicine. - 387 : 14 (2022), p. 1264-1278. -
További szerzők:	Charles-Schoeman, Christina Schessl, Joachim Bata-Csörgő Zsuzsanna Dimachkie, Mazen M. Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Moiseev, Sergey Oddis, Chester V. Schiopu, Elena Vencovsky, Jiri Beckmann, Irene Clodi, Elisabeth Bugrova, Olga Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Ernste, Floranne Goyal, Namita A. Heuer, Marvin Hudson, Marie Hussain, Yessar M. Karam, Chafic Magnolo, Nina Nelson, Ronald Pozur, Nataliia Prystupa, Liudmyla Sárdy Miklós Valenzuela, Guillermo van der Kooi, Anneke J. Vu, Tuan Worm, Margitta Levine, Todd ProDERM Trial Group
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001-es BibID:	BIBFORM115334
035-os BibID:	(WoS)001078071300001
Első szerző:	Hum, Ryan Malcolm
Cím:	Comparison of clinical features between patients with anti-synthetase syndrome and dermatomyositis : results from the MYONET registry / Hum Ryan Malcolm, Lilleker James B., Lamb Janine A., Oldroyd Alexander G. S., Wang Guochun, Wedderburn Lucy R., Diederichsen Louise P., Schmidt Jens, Danieli Maria Giovanna, Oakley Paula, Griger Zoltan, Nguyen Thi Phuong Thuy, Kodishala Chanakya, Vazquez-Del Mercado Monica, Andersson Helena, De Paepe Boel, De Bleecker Jan L., Maurer Britta, McCann Liza, Pipitone Nicolo, McHugh Neil, New Robert Paul, Ollier William E., Krogh Niels Steen, Vencovsky Jiri, Lundberg Ingrid E., Chinoy Hector, MYONET Registry
Dátum:	2023
ISSN:	1462-0324 1462-0332
Megjegyzések:	Objectives: To compare clinical characteristics, including the frequency of cutaneous, extramuscular manifestations, and malignancy, between adults with anti-synthetase syndrome (ASyS) and dermatomyositis (DM). Methods: Using data regarding adults from the MYONET registry, a cohort of DM patients with anti-Mi2/-TIF1?/-NXP2/-SAE/-MDA5 autoantibodies, and a cohort of ASyS patients with anti-tRNA synthetase autoantibodies (anti-Jo1/-PL7/-PL12/-OJ/-EJ/-Zo/-KS) were identified. Patients with DM sine dermatitis or with discordant dual autoantibody specificities were excluded. Sub-cohorts of patients with ASyS with or without skin involvement were defined based on presence of DM-type rashes (heliotrope rash, Gottron's papules/sign, violaceous rash, shawl sign, V sign, erythroderma, and/or periorbital rash). Results: In total 1,054 patients were included (DM, n = 405; ASyS, n = 649). In ASyS cohort, 31% (n = 203) had DM-type skin involvement (ASyS-DMskin). A higher frequency of extramuscular manifestations, including Mechanic's hands, Raynaud's phenomenon, arthritis, interstitial lung disease, and cardiac involvement differentiated ASyS-DMskin from DM (all p< 0.001), whereas higher frequency of any of four DM-type rashes: heliotrope rash (n = 248, 61% vs n = 90, 44%), violaceous rash (n = 166, 41% vs n = 57, 9%), V sign (n = 124, 31% vs n = 28, 4%), and shawl sign (n = 133, 33% vs n = 18, 3%) differentiated DM from ASyS-DMskin (all p< 0.005). Cancer-associated myositis (CAM) was more frequent in DM (n = 67, 17%) compared with ASyS (n = 21, 3%) and ASyS-DMskin (n = 7, 3%) cohorts (both p< 0.001). Conclusion: DM-type rashes are frequent in patients with ASyS; however, distinct clinical manifestations differentiate these patients from classical DM. Skin involvement in ASyS does not necessitate increased malignancy surveillance. These findings will inform future ASyS classification criteria and patient management.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Antisynthetase syndrome MYONET Raynaud's phenomenon cutaneous dermatomyositis epidemiology extramuscular malignancy rashes skin
Megjelenés:	Rheumatology. - [Epub ahead of print] (2023). -
További szerzők:	Lilleker, James B. Lamb, Janine A. Oldroyd, Alexander Wang, Guochun Wedderburn, Lucy R. Diederichsen, Louise Pyndt Schmidt, Jens Danieli, Maria Giovanna Oakley, Paula Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nguyen, Thi Le Phuong Kodishala, Chanakya Vazquez-Del Mercado, Monica Andersson, Helena De Paepe, Boel De Bleecker, Jan Maurer, Britta McCann, Liza J. Pipitone, Nicolo McHugh, Neil New, Robert Paul Ollier, William E. Krogh, Niels Steen Vencovsky, Jiri Lundberg, Ingrid Chinoy, Hector MYONET Registry
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001-es BibID:	BIBFORM117991
035-os BibID:	(cikkazonosító)152379 (scopus)85184773277
Első szerző:	Lodin, Karin
Cím:	Patient global assessment and inflammatory markers in patients with idiopathic inflammatory myopathies : a longitudinal study / Lodin Karin, Espinosa-Ortega Fabricio, Dastmalchi Maryam, Vencovsky Jiri, Andersson Helena, Chinoy Hector, Lilleker James B., Shinjo Samuel Katsuyuki, Maurer Britta, Griger Zoltan, Ceribelli Angela, Torres-Ruiz Jiram, Mercado Mónica Vázquez-Del, Leonard Dag, Alexanderson Helene, Lundberg Ingrid E.
Dátum:	2024
ISSN:	0049-0172
Megjegyzések:	Aim : To explore if patient global assessment (PGA) is associated with inflammation over time and if associations are explained by other measures of disease activity and function in patients with idiopathic inflammatory myopathies (IIM). Methods : PGA and systemic inflammatory markers prospectively collected over five years were retrieved from the International MyoNet registry for 1200 patients with IIM. Associations between PGA, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and creatine kinase (CK) were analysed using mixed models. Mediation analysis was used to test if the association between PGA and inflammatory markers during the first year of observation could be explained by measures of disease activity and function. Results : PGA improved, and inflammatory markers decreased during the first year of observation. In the mixed models, high levels of inflammatory markers were associated with worse PGA in both men and women across time points during five years of observation. In men, but not in women, the association between elevated ESR, CRP and poorer PGA was explained by measures of function and disease activity. With a few exceptions, the association between improved PGA and reduced inflammatory markers was partially mediated by improvements in all measures of function and disease activity. Conclusion : Increased levels of systemic inflammation are associated with poorer PGA in patients with IIM. In addition to known benefits of lowered inflammation, these findings emphasize the need to reduce systemic inflammation to improve subjective health in patients with IIM. Furthermore, the results demonstrate the importance of incorporating PGA as an outcome measure in clinical practice and clinical trials.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Idiopathic inflammatory myopathies myositis patient reported outcome measures inflammation
Megjelenés:	Seminars In Arthritis And Rheumatism. - 65 (2024), p. 1-10. -
További szerzők:	Espinosa-Ortega, Fabricio Dastmalchi, Maryam Vencovsky, Jiri Andersson, Helena Chinoy, Hector Lilleker, James B. Shinjo, Samuel Katsuyuki Maurer, Britta Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Ceribelli, Angela Torres-Ruiz, Jiram Mercado, Mónica Vázquez-Del Leonard, Dag Alexanderson, Helene Lundberg, Ingrid
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