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1.
001-es BibID:
BIBFORM088829
Első szerző:
Pavelka, Karel
Cím:
Upadacitinib versus placebo or adalimumab with background methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate : a subgroup analysis of a phase III randomized controlled trial in Central and Eastern European patients / Pavelka Karel, Szekanecz Zoltán, Damjanov Nemanja, Anić Branimir, Tomšič Matija, Mazurov Vadim, Maksimovic Marija, Nagy Orsolya, Świerkot Jerzy, Petranova Tzvetanka, Veldi Tiina, Baranauskaitè Asta, Codreanu Catalin, Andersone Daina, Fleischmann Roy
Dátum:
2020
ISSN:
1745-1981 1740-4398
Megjegyzések:
Background: In the randomized, phase III, global SELECTCOMPARE study, upadacitinib 15 mg demonstrated efficacy at week 12 versus placebo and adalimumab with methotrexate (MTX) in patients with rheumatoid arthritis and inadequate response to MTX, which was maintained over 48 weeks. This post hoc analysis of SELECT-COMPARE reports the efficacy and safety of upadacitinib in Central and Eastern European (CEE) patients. Methods: Patients were randomized 2:2:1 to upadacitinib 15 mg once daily, placebo, or adalimumab 40 mg every other week, and continued MTX. Efficacy and safety were assessed through 48 weeks. Primary endpoints were the achievement of ?20% improvement in American College of Rheumatology response criteria and Disease Activity Score in 28 joints with C-reactive protein <2.6 responses at week 12 for upadacitinib versus placebo. No statistical comparisons were conducted. Results: A total of 596 patients from 12 CEE countries were randomized. At week 12, a numerically greater proportion of patients receiving upadacitinib versus placebo or adalimumab achieved ?20% improvement in American College of Rheumatology response criteria (72% versus 33% and 59%), Disease Activity Score in 28 joints with C-reactive protein <2.6 (26% versus 4% and 11%), low disease activity and remission, and improved physical function, with results maintained over 48 weeks. Upadacitinib treatment numerically inhibited structural progression versus placebo at week 26. Serious infection and herpes zoster rates were numerically higher with upadacitinib versus adalimumab (2.7 versus 1.7 and 2.3 versus 1.1 events/100 patient-years, respectively) over 48 weeks. Conclusion: Consistent with the global population of patients with rheumatoid arthritis and an inadequate response to MTX, in CEE patients, upadacitinib 15 mg demonstrated clinical and functional improvements versus placebo and adalimumab, radiographic improvements versus placebo, and reasonable safety, over 48 weeks.
Tárgyszavak:
Orvostudományok
Klinikai orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Eastern Europe
rheumatoid arthritis
safety
treatment efficacy
upadacitinib
Megjelenés:
Drugs in Context. - 9 (2020), p. 1-15. -
További szerzők:
Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus)
Damjanov, Nemanja
Anic, Branimir
Tomšič, Matija
Mazurov, Vadim
Maksimovic, Marija
Nagy Orsolya
Świerkot, Jerzy
Petranova, Tzvetanka
Veldi, Tiina
Baranauskaitè, Asta
Codreanu, Catalin
Andersone, Daina
Fleischmann, Roy
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
2.
001-es BibID:
BIBFORM056680
Első szerző:
Pavelka, Karel
Cím:
Etanercept in moderate rheumatoid arthritis : PRESERVE study results from central/eastern Europe, Latin America and Asia / Karel Pavelka, Ruben Burgos-Vargas, Pedro Miranda, Renato Guzman, Jeng-Hsien Yen, Mustafa Al Izzi, Zoltan Szekanecz, Boxiong Tang, Annette Szumski, Sameer Kotak, Eustratios Bananis, Andrew S. Koenig, Ehab Y. Mahgoub, Mahboob U. Rahman
Dátum:
2014
Tárgyszavak:
Orvostudományok
Elméleti orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Köszvény
Megjelenés:
International Journal of Clinical Rheumatology. - 9 (2014), p. 415-430. -
További szerzők:
Burgos-Vargas, Ruben
Miranda, Pedro
Guzman, R.
Yen, Jeng-Hsien
Al Izzi, Mustafa
Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus)
Tang, Boxiong
Szumski, Annette
Kotak, Sameer
Bananis, Eustratios
Koenig, Andrew S.
Mahgoub, Youseif E.
Rahman, Mahboob U.
Internet cím:
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
3.
001-es BibID:
BIBFORM051426
035-os BibID:
PMID:23666316
Első szerző:
Pavelka, Karel
Cím:
Induction of response with etanercept-methotrexate therapy in patients with moderately active rheumatoid arthritis in Central and Eastern Europe in the PRESERVE study / Karel Pavelka, Zoltan Szekanecz, Nemanja Damjanov, Maria Majdan, Evgeny Nasonov, Vadim Mazurov, Tibor Fabo, Eustratios Bananis, Heather Jones, Annette Szumski, Boxiong Tang, Sameer Kotak, Andrew S. Koenig, Radu Vasilescu
Dátum:
2013
ISSN:
0770-3198
Megjegyzések:
Biologics have mainly been assessed in patients with severe rheumatoid arthritis (RA) globally. Less attention has been paid to moderately active disease, especially in Central and Eastern Europe (CEE). Access to biologics and the disease features of RA patients may differ in CEE, relative to other regions. We assessed the clinical and patient-reported outcomes (PROs) of treatment from CEE patients in the multinational PRESERVE study ( NCT00565409 ). Patients with moderate RA 28-joint disease activity score ((DAS28) erythrocyte sedimentation rate (ESR) >3.2 and 5.1) despite methotrexate (MTX) treatment received open-label etanercept (ETN) 50 mg QW + MTX for 36 weeks. Low disease activity (DAS28 low disease activity (LDA) 3.2) and remission (DAS28 ESR <2.6) were assessed. PROs included Health Assessment Questionnaire Disability Index (HAQ-DI), patient global assessment (PGA), EuroQol-5 Dimension (EQ-5D), pain visual analogue scale (VAS), Medical Outcomes Study sleep questionnaire (MOS Sleep), Functional Assessment of Chronic Illness Therapy (FACIT), and Work Productivity and Activity Impairment for RA (WPAI-RA). Descriptive summary statistics were employed. Of the 834 enrolled patients, 302 were from CEE. At baseline, CEE patients had similar disease states versus the overall population. By week 36, LDA was achieved by 87 %, remission by 67 %, and normal HAQ-DI (0.5) by 53 % of patients. Mean scores (SDs) for PROs significantly improved by week 36 as follows: HAQ-DI total by -0.6 (0.5); PGA by -2.4 (2.1); EQ-5D total index by 0.2 (0.2). Pain VAS, MOS Sleep, FACIT, and WPAI-RA also showed significant improvements. In conclusion, induction therapy with ETN + MTX led to DAS28 LDA, remission, and improvements in PROs in most CEE patients with moderately active RA despite treatment with MTX. These results are similar to the overall study population in the PRESERVE trial.
Tárgyszavak:
Orvostudományok
Klinikai orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
köszvény
Megjelenés:
Clinical Rheumatology. - 32 : 9 (2013), p. 1275-1281. -
További szerzők:
Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus)
Damjanov, Nemanja
Majdan, Maria
Nasonov, Evgeny
Mazurov, Vadim
Fabó Tibor
Bananis, Eustratios
Jones, Heather
Szumski, Annette
Tang, Boxiong
Kotak, Sameer
Koenig, Andrew S.
Vasilescu, Radu
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
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