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1.

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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2.

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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3.

001-es BibID:BIBFORM120111
035-os BibID:(Scopus)000972023600001
Első szerző:Ali, Sasha Saadia
Cím:Flares after COVID-19 infection in patients with idiopathic inflammatory myopathies : results from the COVAD study / Ali Sasha Saadia, R. Naveen, Sen Parikshit, Day Jessica, Joshi Mrudula, Nune Arvind, Nikiphorou Elena, Saha Sreoshy, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Ziade Nelly, Velikova Tsvetelina, Milchert Marcin, Jagtap Kshitij, Parodis Ioannis, Edgar Gracia-Ramos Abraham, Cavagna Lorenzo, Kuwana Masataka, Knitza Johannes, Chen Yi Ming, Makol Ashima, Agarwal Vishwesh, Patel Aarat, Pauling John D., Wincup Chris, Barman Bhupen, Zamora Tehozol Erick Adrian, Rojas Serrano Jorge, La Torre Ignacio García-De, Colunga-Pedraza Iris J., Merayo-Chalico Javier, Chibuzo Okwara Celestine, Katchamart Wanruchada, Goo Phonpen Akawatcharangura, Shumnalieva Russka, Hoff Leonardo Santos, El Kibbi Lina, Halabi Hussein, Vaidya Binit, Shaharir Syahrul Sazliyana, Hasan A. T. M. Tanveer, Dey Dzifa, Gutiérrez Carlos Enrique Toro, Caballero-Uribe Carlo Vinicio, Lilleker James B., Salim Babur, Gheita Tamer, Chatterjee Tulika, Distler Oliver, Saavedra Miguel A., Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika, COVAD Study Group
Dátum:2023
ISSN:1462-0324 1462-0332
Tárgyszavak:Orvostudományok Klinikai orvostudományok levél
folyóiratcikk
Megjelenés:Rheumatology. - 62 : 9 (2023), p. e263-e268. -
További szerzők:R., Naveen Sen, Parikshit Day, Jessica Joshi, Mrudula Nune, Arvind Nikiphorou, Elena (reumatológus) Saha, Sreoshy Tan, Ai Lyn Shinjo, Samuel Katsuyuki Ziade, Nelly Velikova, Tsvetelina Milchert, Marcin Jagtap, Kshitij Parodis, Ioannis Gracia-Ramos, Abraham Edgar Cavagna, Lorenzo Kuwana, Masataka Knitza, Johannes Chen, Yi Ming Makol, Ashima Agarwal, Vishwesh Patel, Aarat Pauling, John D. Wincup, Chris Barman, Bhupen Zamora Tehozol, Erick Adrian Rojas Serrano, Jorge La Torre, Ignacio García-De Colunga-Pedraza, Iris J. Merayo-Chalico, Javier Chibuzo, Okwara Celestine Katchamart, Wanruchada Akawatcharangura Goo, Phonpen Shumnalieva, Russka Hoff, Leonardo Santos El Kibbi, Lina Halabi, Hussein Vaidya, Binit Shaharir, Syahrul Sazliyana Hasan, A. T. M. Tanveer Dey, Dzifa Gutiérrez, Carlos-Enrique Toro Caballero-Uribe, Carlo Vinicio Lilleker, James B. Salim, Babur Gheita, Tamer A. Chatterjee, Tulika Distler, Oliver Saavedra, Miguel A. Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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4.

001-es BibID:BIBFORM117878
035-os BibID:(WOS)001051657500001
Első szerző:Andreoli, Laura
Cím:COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases : results from the COVAD study / Andreoli Laura, Lini Daniele, Schreiber Karen, Parodis Ioannis, Sen Parikshit, Ravichandran Naveen, Day Jessica, Joshi Mrudula, Jagtap Kshitij, Nune Arvind, Nikiphorou Elena, Agarwal Vishwesh, Saha Sreoshy, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Ziade Nelly, Velikova Tsvetelina, Milchert Marcin, Gracia-Ramos, Abraham Edgar, Cavagna Lorenzo, Kuwana Masataka, Knitza Johannes, Makol Ashima, Patel Aarat, Pauling John D., Wincup Chris, Barman Bhupen, Zamora Tehozol Erick Adrian, Serrano Jorge Rojas, De La Torre Ignacio García, Colunga-Pedraza Iris J., Merayo-Chalico Javier, Chibuzo Okwara Celestine, Katchamart Wanruchada, Akarawatcharangura Goo Phonpen, Shumnalieva Russka, Chen Yi-Ming, Hoff Leonardo Santos, El Kibbi Lina, Halabi Hussein, Vaidya Binit, Shaharir Syahrul Sazliyana, Hasan A. T. M. Tanveer, Dey Dzifa, Toro Gutiérrez Carlos Enrique, Caballero-Uribe Carlo V., Lilleker James B., Salim Babur, Gheita Tamer, Chatterjee Tulika, Saavedra Miguel A., Distler Oliver, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika, COVAD Study Group
Dátum:2023
ISSN:1462-0324 1462-0332
Megjegyzések:Objectives: We investigated COVID-19 vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. Methods: Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares (DF), and AID-related treatment modifications were analyzed upon diagnosis of AID versus healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine. Results: Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, p= 0.01; minor AE 40% vs 25.9%, p= 0.03; major AE 17.5% vs 4.6%, p< 0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC with respect to AE. Post-vaccination DF were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18.3% of age- and disease-matched non-pregnant and non-breastfeeding patients (n = 262). All pregnant/breastfeeding patients who experienced a DF were managed with glucocorticoids; 28.6% and 20% of them required initiation or change in immunosuppressants, respectively. Conclusion: This study provides reassuring insights into the safety of COVID-19 vaccines administered to women with AID during the gestational and post-partum periods, helping overcome hesitant attitudes, as the benefits for the mother and the fetus by passive immunization appear to outweigh potential risks.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
COVID-19 vaccination
adverse events
autoimmune diseases
breastfeeding
disease flare
pregnancy
treatment
Megjelenés:Rheumatology. - [Epub ahead of print] (2023). -
További szerzők:Lini, Daniele Schreiber, Karen Parodis, Ioannis Sen, Parikshit Ravichandran, Naveen Day, Jessica Joshi, Mrudula Jagtap, Kshitij Nune, Arvind Nikiphorou, Elena (reumatológus) Agarwal, Vishwesh Saha, Sreoshy Tan, Ai Lyn Shinjo, Samuel Katsuyuki Ziade, Nelly Velikova, Tsvetelina Milchert, Marcin Gracia-Ramos, Abraham Edgar Cavagna, Lorenzo Kuwana, Masataka Knitza, Johannes Makol, Ashima Patel, Aarat Pauling, John D. Wincup, Chris Barman, Bhupen Zamora Tehozol, Erick Adrian Serrano, Jorge Rojas De La Torre, Ignacio García Colunga-Pedraza, Iris J. Merayo-Chalico, Javier Chibuzo, Okwara Celestine Katchamart, Wanruchada Akawatcharangura Goo, Phonpen Shumnalieva, Russka Chen, Yi-Ming Hoff, Leonardo Santos El Kibbi, Lina Halabi, Hussein Vaidya, Binit Shaharir, Syahrul Sazliyana Hasan, A. T. M. Tanveer Dey, Dzifa Toro Gutiérrez, Carlos Enrique Caballero-Uribe, Carlo Vinicio Lilleker, James B. Salim, Babur Gheita, Tamer A. Chatterjee, Tulika Saavedra, Miguel A. Distler, Oliver Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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5.

001-es BibID:BIBFORM105682
035-os BibID:(Scopus)85160969875 (WoS)000892566100001
Első szerző:Andreoli, Laura
Cím:COVID-19 vaccine safety during the antenatal period in women with idiopathic inflammatory myopathies / Andreoli Laura, Sen Parikshit, Lini Daniele, Vincze Melinda Nagy, Schreiber Karen, Agarwal Vikas, Aggarwal Rohit, Gupta Latika, COVAD Study Group
Dátum:2023
ISSN:1462-0324 1462-0332
Megjegyzések:Vaccine hesitancy is considered a major barrier to achieving herd immunity against COVID-19. While multiple alternative and synergistic approaches including heterologous vaccination, booster doses, and antiviral drugs have been developed, equitable vaccine uptake remains the foremost strategy to manage pandemic. Although none of the currently approved vaccines are live-attenuated, several reports of disease flares, waning protection, and acute-onset syndromes have emerged as short-term adverse events after vaccination. Hence, scientific literature falls short when discussing potential long-term effects in vulnerable cohorts. The COVAD-2 survey follows on from the baseline COVAD-1 survey with the aim to collect patient-reported data on the long-term safety and tolerability of COVID-19 vaccines in immune modulation. The e-survey has been extensively pilot-tested and validated with translations into multiple languages. Anticipated results will help improve vaccination efforts and reduce the imminent risks of COVID-19 infection, especially in understudied vulnerable groups.
Tárgyszavak:Orvostudományok Klinikai orvostudományok levél
folyóiratcikk
Autoimmune diseases
COVID-19
Long-term adverse effects
Registries
Vaccination
Megjelenés:Rheumatology. - 62 : 6 (2023), p. e175-e179. -
További szerzők:Sen, Parikshit Lini, Daniele Nagy-Vincze Melinda (1985-) (orvos) Schreiber, Karen Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) COVAD Study Group
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6.

001-es BibID:BIBFORM117879
035-os BibID:(scopus)85162972096 (wos)001014747300001
Első szerző:Doskaliuk, Bohdana
Cím:Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies : results from the COVAD study / Doskaliuk Bohdana, Ravichandran Naveen, Sen Parikshit, Day Jessica, Joshi Mrudula, Nune Arvind, Nikiphorou Elena, Saha Sreoshy, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Ziade Nelly, Velikova Tsvetelina, Milchert Marcin, Jagtap Kshitij, Parodis Ioannis, Gracia-Ramos Abraham Edgar, Cavagna Lorenzo, Kuwana Masataka, Knitza Johannes, Chen Yi Ming, Makol Ashima, Agarwal Vishwesh, Patel Aarat, Pauling John D., Wincup Chris, Barman Bhupen, Tehozol Erick Adrian Zamora, Serrano Jorge Rojas, La Torre Ignacio García-De, Colunga-Pedraza Iris J., Merayo-Chalico Javier, Chibuzo Okwara Celestine, Katchamart Wanruchada, Goo Phonpen Akarawatcharangura, Shumnalieva Russka, Hoff Leonardo Santos, Kibbi Lina El, Halabi Hussein, Vaidya Binit, Shaharir Syahrul Sazliyana, Hasan A. T. M. Tanveer, Dey Dzifa, Gutiérrez Carlos Enrique Toro, Caballero-Uribe Carlo V., Lilleker James B., Salim Babur, Gheita Tamer, Chatterjee Tulika, Distler Oliver, Saavedra Miguel A., COVAD study group, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika
Dátum:2023
ISSN:0172-8172 1437-160X
Megjegyzések:Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb-June 2022. We collected data on demographics, comorbidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35-58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2-7.0, p < 0.001]. IIM patients with active disease, overlap myositis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Adverse event
Autoimmunity
COVID-19
Myositis
Surveys and questionnaires
Vaccination
Megjelenés:Rheumatology International. - 43 : 9 (2023), p. 1651-1664. -
További szerzők:Ravichandran, Naveen Sen, Parikshit Day, Jessica Joshi, Mrudula Nune, Arvind Nikiphorou, Elena (reumatológus) Saha, Sreoshy Tan, Ai Lyn Shinjo, Samuel Katsuyuki Ziade, Nelly Velikova, Tsvetelina Milchert, Marcin Jagtap, Kshitij Parodis, Ioannis Gracia-Ramos, Abraham Edgar Cavagna, Lorenzo Kuwana, Masataka Knitza, Johannes Chen, Yi Ming Makol, Ashima Agarwal, Vishwesh Patel, Aarat Pauling, John D. Wincup, Chris Barman, Bhupen Tehozol, Erick Adrian Zamora Serrano, Jorge Rojas La Torre, Ignacio García-De Colunga-Pedraza, Iris J. Merayo-Chalico, Javier Chibuzo, Okwara Celestine Katchamart, Wanruchada Akawatcharangura Goo, Phonpen Shumnalieva, Russka Hoff, Leonardo Santos Kibbi, Lina El Halabi, Hussein Vaidya, Binit Shaharir, Syahrul Sazliyana Hasan, A. T. M. Tanveer Dey, Dzifa Gutiérrez, Carlos-Enrique Toro Caballero-Uribe, Carlo Vinicio Lilleker, James B. Salim, Babur Gheita, Tamer A. Chatterjee, Tulika Distler, Oliver Saavedra, Miguel A. Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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7.

001-es BibID:BIBFORM105749
035-os BibID:(scopus)85139571711 (wos)000840395200001
Első szerző:Fazal, Zoha Zahid
Cím:COVAD survey 2 long-term outcomes : unmet need and protocol / Fazal Zoha Zahid, Sen Parikshit, Joshi Mrudula, Ravichandran Naveen, Lilleker James B., Agarwal Vishwesh, Kardes Sinan, Kim Minchul, Day Jessica, Makol Ashima, Milchert Marcin, Gheita Tamer, Salim Babur, Velikova Tsvetelina, Gracia-Ramos Abraham Edgar, Parodis Ioannis, Nikiphorou Elena, Tan Ai Lyn, Chatterjee Tulika, Cavagna Lorenzo, Saavedra Miguel A., Shinjo Samuel Katsuyuki, Ziade Nelly, Selva-O'Callaghan Albert, Nune Arvind, Knitza Johannes, Kuwana Masataka, Gutiérrez Carlos-Enrique Toro, Caballero-Uribe Carlo Vinicio, Dey Dzifa, Distler Oliver, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika, COVAD Study Group
Dátum:2022
ISSN:0172-8172 1437-160X
Megjegyzések:Vaccine hesitancy is considered a major barrier to achieving herd immunity against COVID-19. While multiple alternative and synergistic approaches including heterologous vaccination, booster doses, and antiviral drugs have been developed, equitable vaccine uptake remains the foremost strategy to manage pandemic. Although none of the currently approved vaccines are live-attenuated, several reports of disease flares, waning protection, and acute-onset syndromes have emerged as short-term adverse events after vaccination. Hence, scientific literature falls short when discussing potential long-term effects in vulnerable cohorts. The COVAD-2 survey follows on from the baseline COVAD-1 survey with the aim to collect patient-reported data on the long-term safety and tolerability of COVID-19 vaccines in immune modulation. The e-survey has been extensively pilot-tested and validated with translations into multiple languages. Anticipated results will help improve vaccination efforts and reduce the imminent risks of COVID-19 infection, especially in understudied vulnerable groups.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Autoimmune diseases
COVID-19
Long-term adverse effects
Registries
Vaccination
Megjelenés:Rheumatology International. - 42 : 12 (2022), p. 2151-2158. -
További szerzők:Sen, Parikshit Joshi, Mrudula Ravichandran, Naveen Lilleker, James B. Agarwal, Vishwesh Kardes, Sinan Kim, Minchul Day, Jessica Makol, Ashima Milchert, Marcin Gheita, Tamer A. Salim, Babur Velikova, Tsvetelina Gracia-Ramos, Abraham Edgar Parodis, Ioannis Nikiphorou, Elena (reumatológus) Tan, Ai Lyn Chatterjee, Tulika Cavagna, Lorenzo Saavedra, Miguel A. Shinjo, Samuel Katsuyuki Ziade, Nelly Selva-O'Callaghan, Albert Nune, Arvind Knitza, Johannes Kuwana, Masataka Gutiérrez, Carlos-Enrique Toro Caballero-Uribe, Carlo Vinicio Dey, Dzifa Distler, Oliver Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Nagy-Vincze Melinda (1985-) (orvos) Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) COVAD Study Group
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8.

001-es BibID:BIBFORM120112
035-os BibID:(WoS)000992238900001 (Scopus)85178648976
Első szerző:Jagtap, Kshitij
Cím:Flares in autoimmune rheumatic diseases in the post-COVID-19 vaccination period : a cross-sequential study based on COVAD surveys / Jagtap Kshitij, Naveen R., Day Jessica, Sen Parikshit, Vaidya Binit, Nune Arvind, Nikiphorou Elena, Tan Ai Lyn, Agarwal Vishwesh, Saha Sreoshy, Shinjo Samuel Katsuyuki, Ziade Nelly, Joshi Mrudula, Velikova Tsvetelina, Milchert Marcin, Parodis Ioannis, Edgar Gracia-Ramos Abraham, Cavagna Lorenzo, Kuwana Masataka, Knitza Johannes, Makol Ashima, Patel Aarat, Pauling John D., Wincup Chris, Barman Bhupen, Zamora Tehozol Erick Adrian, Rojas Serrano Jorge, García-De La Torre Ignacio, Colunga-Pedraza Iris J., Merayo-Chalico Javier, Chibuzo Okwara Celestine, Katchamart Wanruchada, Goo Phonpen Akawatcharangura, Shumnalieva Russka, Chen Yi-Ming, Hoff Leonardo Santos, El Kibbi Lina, Halabi Hussein, Sazliyana Shaharir Syahrul, Hasan A. T. M. Tanveer, Dey Dzifa, Gutiérrez Carlos Enrique Toro, Caballero-Uribe Carlo Vinicio, Lilleker James B., Salim Babur, Gheita Tamer, Chatterjee Tulika, Saavedra Miguel A., Distler Oliver, COVAD Study Group, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika
Dátum:2023
ISSN:1462-0324 1462-0332
Megjegyzések:Objective: Flares of autoimmune rheumatic diseases (AIRDs) following COVID-19 vaccination are a particular concern in vaccine-hesitant individuals. Therefore, we investigated the incidence, predictors and patterns of flares following vaccination in individuals living with AIRDs, using global COVID-19 Vaccination in Autoimmune Diseases (COVAD) surveys. Methods: The COVAD surveys were used to extract data on flare demographics, comorbidities, COVID-19 history, and vaccination details for patients with AIRDs. Flares following vaccination were identified as patient-reported (a), increased immunosuppression (b), clinical exacerbations (c) and worsening of PROMIS scores (d). We studied flare characteristics and used regression models to differentiate flares among various AIRDs. Results: Of 15 165 total responses, the incidence of flares in 3453 patients with AIRDs was 11.3%, 14.8%, 9.5% and 26.7% by definitions a-d, respectively. There was moderate agreement between patient-reported and immunosuppression-defined flares (K = 0.403, P = 0.022). Arthritis (61.6%) and fatigue (58.8%) were the most commonly reported symptoms. Self-reported flares were associated with higher comorbidities (P = 0.013), mental health disorders (MHDs) (P < 0.001) and autoimmune disease multimorbidity (AIDm) (P < 0.001).In regression analysis, the presence of AIDm [odds ratio (OR) = 1.4; 95% CI: 1.1, 1.7; P = 0.003), or a MHD (OR = 1.7; 95% CI: 1.1, 2.6; P = 0.007), or being a Moderna vaccine recipient (OR = 1.5; 95% CI: 1.09, 2.2; P = 0.014) were predictors of flares. Use of MMF (OR = 0.5; 95% CI: 0.3, 0.8; P = 0.009) and glucocorticoids (OR = 0.6; 95% CI: 0.5, 0.8; P = 0.003) were protective.A higher frequency of patients with AIRDs reported overall active disease post-vaccination compared with before vaccination (OR = 1.3; 95% CI: 1.1, 1.5; P < 0.001). Conclusion: Flares occur in nearly 1 in 10 individuals with AIRDs after COVID vaccination; people with comorbidities (especially AIDm), MHDs and those receiving the Moderna vaccine are particularly vulnerable. Future avenues include exploring flare profiles and optimizing vaccine strategies for this group.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
COVID-19
autoimmunity
flares
rheumatic
vaccination
vaccination hesitancy
Megjelenés:Rheumatology. - 62 : 12 (2023), p. 3838-3848. -
További szerzők:Naveen, R. Day, Jessica Sen, Parikshit Vaidya, Binit Nune, Arvind Nikiphorou, Elena (reumatológus) Tan, Ai Lyn Agarwal, Vishwesh Saha, Sreoshy Shinjo, Samuel Katsuyuki Ziade, Nelly Joshi, Mrudula Velikova, Tsvetelina Milchert, Marcin Parodis, Ioannis Gracia-Ramos, Abraham Edgar Cavagna, Lorenzo Kuwana, Masataka Knitza, Johannes Makol, Ashima Patel, Aarat Pauling, John D. Wincup, Chris Barman, Bhupen Zamora Tehozol, Erick Adrian Rojas Serrano, Jorge García-De La Torre, Ignacio Colunga-Pedraza, Iris J. Merayo-Chalico, Javier Chibuzo, Okwara Celestine Katchamart, Wanruchada Akawatcharangura Goo, Phonpen Shumnalieva, Russka Chen, Yi-Ming Hoff, Leonardo Santos El Kibbi, Lina Halabi, Hussein Sazliyana Shaharir, Syahrul Hasan, A. T. M. Tanveer Dey, Dzifa Gutiérrez, Carlos-Enrique Toro Caballero-Uribe, Carlo Vinicio Lilleker, James B. Salim, Babur Gheita, Tamer A. Chatterjee, Tulika Saavedra, Miguel A. Distler, Oliver Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) COVAD Study Group
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DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:

9.

001-es BibID:BIBFORM110887
035-os BibID:(WoS)000999243100001 (Scopus)85180733005
Első szerző:Naveen, R.
Cím:Flares in IIMs and the timeline following COVID-19 vaccination : a combined analysis of the COVAD-1 and 2 surveys / Naveen R., Sen Parikshit, Griger Zoltán, Day Jessica, Joshi Mrudula, Nune Arvind, Nikiphorou Elena, Saha Sreoshy, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Ziade Nelly, Velikova Tsvetelina, Milchert Marcin, Jagtap Kshitij, Parodis Ioannis, Edgar Gracia-Ramos Abraham, Cavagna Lorenzo, Kuwana Masataka, Knitza Johannes, Chen Yi Ming, Makol Ashima, Agarwal Vishwesh, Patel Aarat, Pauling John D., Wincup Chris, Barman Bhupen, Zamora Tehozol Erick Adrian, Serrano Jorge Rojas, García-De La Torre Ignacio, Colunga-Pedraza Iris J., Merayo-Chalico Javier, Chibuzo Okwara Celestine, Katchamart Wanruchada, Goo Phonpen Akawatcharangura, Shumnalieva Russka, Hoff Leonardo Santos, Kibbi El Lina, Halabi Hussein, Vaidya Binit, Shaharir Syahrul Sazliyana, Hasan A. T. M. Tanveer, Dey Dzifa, Gutiérrez Carlos Enrique Toro, Caballero-Uribe Carlo Vinicio, Lilleker James B., Salim Babur, Gheita Tamer, Chatterjee Tulika, Distler Oliver, Saavedra Miguel A., COVAD study group, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika
Dátum:2024
ISSN:1462-0324 1462-0332
Megjegyzések:Objectives: Disease flares in the post COVID-19 vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs). Methods: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022 respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history, and vaccination details.Flares of IIMs were defined as a. patient self-reported, b. immunosuppression (IS) denoted, c. clinical sign directed, and d. with >7.9-point MCID worsening of PROMISPF10a score. Risk factors of flares were analyzed using regression models. Results: Of 15165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians), and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7%, and 19.6% patients by definitions a-d respectively with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR:1.2; 95%CI:1.03-1.6, p = 0.025) were prone to flares, while those receiving Rituximab (OR:0.3; 95%CI:0.1-0.7, p = 0.010) and Azathioprine (OR:0.3, 95%CI:0.1-0.8, p = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in immunosuppression. Asthma (OR: 1.62; 95%CI: 1.05-2.50, p = 0.028) and higher pain VAS (OR: 1.19; 95%CI: 1.11-1.27, p < 0.001) were associated with disparity between self-reported and IS-denoted flares. Conclusion: A diagnosis of IIMs confers an equal risk of flares in the post COVID-19 vaccination period to AIRDs, with active disease, female gender, and comorbidities conferring a higher risk. Disparity between patient and physician reported outcomes represents a future avenue for exploration.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
COVID-19 Vaccines
Disease Exacerbation
Idiopathic Inflammatory Myopathies
Patient Reported Outcomes
Megjelenés:Rheumatology. - 63 : 1 (2024), p. 127-139. -
További szerzők:Sen, Parikshit Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Day, Jessica Joshi, Mrudula Nune, Arvind Nikiphorou, Elena (reumatológus) Saha, Sreoshy Tan, Ai Lyn Shinjo, Samuel Katsuyuki Ziade, Nelly Velikova, Tsvetelina Milchert, Marcin Jagtap, Kshitij Parodis, Ioannis Gracia-Ramos, Abraham Edgar Cavagna, Lorenzo Kuwana, Masataka Knitza, Johannes Chen, Yi Ming Makol, Ashima Agarwal, Vishwesh Patel, Aarat Pauling, John D. Wincup, Chris Barman, Bhupen Zamora Tehozol, Erick Adrian Serrano, Jorge Rojas García-De La Torre, Ignacio Colunga-Pedraza, Iris J. Merayo-Chalico, Javier Chibuzo, Okwara Celestine Katchamart, Wanruchada Akawatcharangura Goo, Phonpen Shumnalieva, Russka Hoff, Leonardo Santos El Kibbi, Lina Halabi, Hussein Vaidya, Binit Shaharir, Syahrul Sazliyana Hasan, A. T. M. Tanveer Dey, Dzifa Gutiérrez, Carlos-Enrique Toro Caballero-Uribe, Carlo Vinicio Lilleker, James B. Salim, Babur Gheita, Tamer A. Chatterjee, Tulika Distler, Oliver Saavedra, Miguel A. Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:

10.

001-es BibID:BIBFORM116491
035-os BibID:(wos)001103143700001 (scopus)85176609027
Első szerző:Oldroyd, Alexander
Cím:International Guideline for Idiopathic Inflammatory Myopathy-Associated Cancer Screening : an International Myositis Assessment and Clinical Studies Group (IMACS) initiative / Alexander G. S. Oldroyd, Jeffrey P. Callen, Hector Chinoy, Lorinda Chung, David Fiorentino, Patrick Gordon, Pedro M. Machado, Neil McHugh, Albert Selva-O'Callaghan, Jens Schmidt, Sarah L. Tansley, Ruth Ann Vleugels, Victoria P. Werth, International Myositis Assessment and Clinical Studies Group Cancer Screening Expert Group, Rohit Aggarwal
Dátum:2023
ISSN:1759-4790 1759-4804
Megjegyzések:Adult-onset idiopathic inflammatory myopathy (IIM) is associated with an increased cancer risk within the 3 years preceding and following IIM onset. Evidence- and consensus-based recommendations for IIM-associated cancer screening can potentially improve outcomes. This International Guideline for IIM-Associated Cancer Screening provides recommendations addressing IIM-associated cancer risk stratification, cancer screening modalities and screening frequency. The international Expert Group formed a total of 18 recommendations via a modified Delphi approach using a series of online surveys. First, the recommendations enable an individual patient's IIM-associated cancer risk to be stratified into standard, moderate or high risk according to the IIM subtype, autoantibody status and clinical features. Second, the recommendations outline a 'basic' screening panel (including chest radiography and preliminary laboratory tests) and an 'enhanced' screening panel (including CT and tumour markers). Third, the recommendations advise on the timing and frequency of screening via basic and enhanced panels, according to risk status. The recommendations also advise consideration of upper or lower gastrointestinal endoscopy, nasoendoscopy and 18F-FDG PET-CT scanning in specific patient populations. These recommendations are aimed at facilitating earlier IIM-associated cancer detection, especially in those who are at a high risk, thus potentially improving outcomes, including survival.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Nature Reviews Rheumatology. - 19 : 12 (2023), p. 805-817. -
További szerzők:Callen, Jeffrey P. Chinoy, Hector Chung, Lorinda Fiorentino, David Gordon, Patrick Machado, Pedro M. McHugh, Neil Selva-O'Callaghan, Albert Schmidt, Jens Tansley, Sarah Vleugels, Ruth Ann Werth, Victoria P. Aggarwal, Rohit Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nagy-Vincze Melinda (1985-) (orvos) International Myositis Assessment and Clinical Studies Group Cancer Screening Expert Group
Internet cím:Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:

11.

001-es BibID:BIBFORM117880
035-os BibID:(WOS)001116143800001 (Scopus)85181481512
Első szerző:Panchawagh, Suhrud
Cím:COVID-19 breakthrough infections in type 1 diabetes mellitus : a cross-sectional study by the COVID-19 Vaccination in Autoimmune Diseases (COVAD) Group / Panchawagh Suhrud, Ravichandran Naveen, Barman Bhupen, Nune Arvind, Javaid Mahnoor, Gracia-Ramos Abraham Edgar, Day Jessica, Joshi Mrudula, Kuwana Masataka, Saha Sreoshy, Pande Arunkumar R., Caballero-Uribe Carlo Vinicio, Velikova Tsvetelina, Parodis Ioannis, Knitza Johannes, Kadam Esha, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Boro Hiya, COVAD Study Group, Aggarwal Rohit, Agarwal Vikas, Chatterjee Tulika, Gupta Latika
Dátum:2023
ISSN:0172-8172 1437-160X
Megjegyzések:To investigate the frequency, profile, and severity of COVID-19 breakthrough infections (BI) in patients with type I diabetes mellitus (T1DM) compared to healthy controls (HC) after vaccination. The second COVID-19 Vaccination in Autoimmune Diseases (COVAD-2) survey is a multinational cross-sectional electronic survey which has collected data on patients suffering from various autoimmune diseases including T1DM. We performed a subgroup analysis on this cohort to investigate COVID-19 BI characteristics in patients with T1DM. Logistic regression with propensity score matching analysis was performed. A total of 9595 individuals were included in the analysis, with 100 patients having T1DM. Among the fully vaccinated cohort, 16 (16%) T1DM patients had one BI and 2 (2%) had two BIs. No morbidities or deaths were reported, except for one patient who required hospitalization with oxygen without admission to intensive care. The frequency, clinical features, and severity of BIs were not significantly different between T1DM patients and HCs after adjustment for confounding factors. Our study did not show any statistically significant differences in the frequency, symptoms, duration, or critical care requirements between T1DM and HCs after COVID-19 vaccination. Further research is needed to identify factors associated with inadequate vaccine response in patients with BIs, especially in patients with autoimmune diseases.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Breakthrough infections
COVID-19
Survey
Type 1 diabetes mellitus
Vaccine
Megjelenés:Rheumatology International. - 44 : 1 (2023), p. 73-80. -
További szerzők:Ravichandran, Naveen Barman, Bhupen Nune, Arvind Javaid, Mahnoor Gracia-Ramos, Abraham Edgar Day, Jessica Joshi, Mrudula Kuwana, Masataka Saha, Sreoshy Pande, Arunkumar R. Caballero-Uribe, Carlo Vinicio Velikova, Tsvetelina Parodis, Ioannis Knitza, Johannes Kadam, Esha Tan, Ai Lyn Shinjo, Samuel Katsuyuki Boro, Hiya Aggarwal, Rohit Agarwal, Vikas Chatterjee, Tulika Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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Intézményi repozitóriumban (DEA) tárolt változat
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