المؤلفون: Baraliakos, X, Ranza, R, Östör, A, Ciccia, F, Coates, LC, Rednic, S, Walsh, JA, Douglas, K, Gao, T, Kato, K, Song, I-H, Ganz, F, Deodhar, A

الوصف: Background The objective of this post-hoc analysis was to assess the efficacy and safety of upadacitinib in psoriatic arthritis (PsA) patients with axial involvement. Methods Post-hoc analysis of SELECT-PsA 1 and SELECT-PsA 2 in patients randomized to upadacitinib 15 mg (UPA15), placebo (switched to UPA15 at week 24), or adalimumab 40 mg (ADA; SELECT-PsA 1 only). Axial involvement was determined by investigator judgement (yes or no; based on the totality of available clinical information, such as duration and characteristics of back pain, age of onset, and previous lab investigations and imaging, if available) alone, or investigator judgement and patient-reported outcome (PRO)-based criteria (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥ 4 and BASDAI Q2 ≥ 4). Efficacy outcomes that describe axial disease activity, including BASDAI endpoints, such as change from baseline in the overall BASDAI score or proportion of patients achieving BASDAI50 (≥ 50% improvement from baseline), as well as Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints, such as mean change from baseline in overall ASDAS or proportion of patients achieving ASDAS inactive disease or low disease activity, were evaluated at weeks 12, 24, and 56, with nominal P-values shown. Treatment-emergent adverse events (TEAEs) are summarized through week 56. Results 30.9% of patients in SELECT-PsA 1 and 35.7% in SELECT-PsA 2 had axial involvement by investigator judgement alone; 22.6% (SELECT-PsA 1) and 28.6% (SELECT-PsA 2) had axial involvement by investigator judgement and PRO-based criteria. Greater proportions of patients achieved BASDAI50 with UPA15 versus placebo using either criterion, and versus ADA using investigator judgement alone, at week 24 in SELECT-PsA 1 (investigator alone: UPA15, 59.0%, placebo, 26.9%, P Conclusions PsA patients with axial involvement determined by predefined criteria showed greater BASDAI and ASDAS responses with UPA15 versus placebo, and numerically similar/greater responses versus ADA. Safety ...

العلاقة: https://ora.ox.ac.uk/objects/uuid:69d27839-67dc-4348-8e4c-6e3a8037dcfdTest; https://doi.org/10.1186/s13075-023-03027-5Test

الإتاحة: https://doi.org/10.1186/s13075-023-03027-5Test
https://ora.ox.ac.uk/objects/uuid:69d27839-67dc-4348-8e4c-6e3a8037dcfdTest

المؤلفون: Alpizar-Rodriguez, D., Isnardi, C. A., Rivera Terán, V., Laurindo, I. M., Pons-Estel, G., Haye Salinas, M., Exeni, I. E., Alvarado, R. N., Gomez, G., Brigante, A., Pinheiro, M., Ranza, R., Castro, G., Fernandes, V., Brenol, C., Antonio Araujo Da Rocha Loures, M., Vega-Morales, D., Colunga-Pedraza, I. J., Sicsik, S., Saavedra Salinas, M. A., Casasola, J. C., Avila, G., Cabrera-Villalba, S., Melgarejo, P., Pusineri, P., Aranda, R., Jara Gomez, P., Soto Estevez, M., Brunengo, C., Cordovilla, D., Acevedo, B., Consani-Fernández, S., Rostan, S., De Abreu Trigueros, P.

المصدر: Scientific Abstracts

الإتاحة: https://doi.org/10.1136/annrheumdis-2024-eular.4633Test

المؤلفون: Aletaha D, Husni ME, Merola JF, Ranza R, Bertheussen H, Lippe R, Young PM, Cappelleri JC, Brown TM, Ervin C, Hsu MA, Fallon L

المصدر: Patient Preference and Adherence, Vol Volume 14, Pp 949-961 (2020)

مصطلحات موضوعية: psoriatic arthritis, patient preference, qualitative research, treatment administration, Medicine (General), R5-920

الوصف: Daniel Aletaha,1 M Elaine Husni,2 Joseph F Merola,3 Roberto Ranza,4 Heidi Bertheussen,5 Ralph Lippe,6 Pamela M Young,7 Joseph C Cappelleri,8 T Michelle Brown,9 Claire Ervin,9 Ming-Ann Hsu,10 Lara Fallon11 1Division of Rheumatology, Department of Internal Medicine 3, Medical University of Vienna, Vienna, Austria; 2Cleveland Clinic, Department of Rheumatic and Immunologic Diseases, Cleveland, OH, USA; 3Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; 4Serviço de Reumatología, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil; 5Patient Representative, Oslo, Norway; 6Inflammation & Immunology, Pfizer Pharma GmbH, Berlin, Germany; 7Inflammation & Immunology, Pfizer Inc, Collegeville, PA, USA; 8Statistics, Pfizer Inc, Groton, CT, USA; 9RTI Health Solutions, Research Triangle Park, NC, USA; 10Health Economics & Outcomes Research, Pfizer Inc, Groton, CT, USA; 11Medical Affairs, Pfizer Inc, Montreal, QC, CanadaCorrespondence: Daniel AletahaDivision of Rheumatology, Department of Internal Medicine 3, Medical University of Vienna, Währinger Gürtel 18– 20, Vienna 1090, AustriaEmail daniel.aletaha@meduniwien.ac.atObjective: Qualitative research exploring patient preferences regarding the mode of treatment administration for psoriatic arthritis (PsA) is limited. We report patient preferences and their reasons across PsA treatment modes.Methods: In this global, cross-sectional, qualitative study, interviews were conducted with adult patients with PsA in Brazil, France, Germany, Italy, Spain, the UK, and the US. Patients were currently taking a disease-modifying antirheumatic drug (DMARD). Patients indicated the order and strength of preference (0– 100; 100 = strongest) across four modes of treatment administration: oral (once daily), self-injection (weekly), clinic injection (weekly), and infusion (monthly); reasons for preferences were qualitatively assessed. Descriptive statistics were reported. Fisher’s exact tests and t-tests were conducted for treatment mode outcomes.Results: Overall, 85 patients were interviewed (female, 60.0%; mean age, 49.8 years). First-choice ranking (%) and mean [standard deviation] preference points were: oral (49.4%; 43.9 [31.9]); self-injection (34.1%; 32.4 [24.8]); infusion (15.3%; 14.5 [20.0]); clinic injection (1.2%; 9.2 [10.0]). Of 48 (56.5%) patients with a strong first-choice preference (ie point allocation ≥ 60), 66.7% chose oral administration. Self-injection was most often selected as second choice (51.8%), clinic injection as third (49.4%), and infusion as fourth (47.1%). Oral administration was the first-choice preference in the US (88.0% vs 38.0% in Europe). The most commonly reported reason for oral administration as the first choice was speed and ease of administration (76.2%); for self-injection, this was convenience (75.9%). The most commonly reported reason for avoiding oral administration was concern about possible drug interactions (63.6%); for self-injection, this was a dislike of needles or the injection process (66.7%).Conclusion: Patients with PsA preferred oral treatment administration, followed by self-injection; convenience factors were common reasons for these preferences. Overall, 43.5% of patients did not feel strongly about their first-choice preference and may benefit from discussions with healthcare professionals about PsA treatment administration options.Keywords: psoriatic arthritis, patient preference, qualitative research, treatment administration

وصف الملف: electronic resource

العلاقة: https://www.dovepress.com/treatment-mode-preferences-in-psoriatic-arthritis-a-qualitative-multi--peer-reviewed-article-PPATest; https://doaj.org/toc/1177-889XTest

الوصول الحر: https://doaj.org/article/b31ee86e8134417691db402e15c60765Test

المؤلفون: Gossec, L, Gladman, DD, Mcdearmon-Blondell, E, Sewerin, P, Ritchlin, CT, Feng, D, Lertratanakul, A, Ranza, R, Tam, LS, Marchesoni, A, Coates, LC, Nash, P

مصطلحات موضوعية: Clinical sciences, Immunology, Science & Technology, Life Sciences & Biomedicine, Rheumatology

جغرافية الموضوع: Virtual

الوقت: 2021-06-02 to 2021-06-05

الوصف: Background: Although most patients with psoriatic arthritis (PsA) enrolled in clinical trials have polyarticular arthritis, patients in clinical practice may present with oligoarthritis. Data on the efficacy of Janus kinase inhibitors in patients with PsA with low joint counts are limited. Objectives: To evaluate the efficacy of upadacitinib (UPA) in subgroups of patients with PsA with a low (baseline swollen joint count [SJC] <5) or high (SJC ≥5) SJC (LSJ or HSJ). Methods: Data were pooled across the SELECT-PsA 11 (non-biologic disease-modifying antirheumatic drug [non-bDMARD] inadequate response [IR] or intolerance) and SELECT-PsA 22 (bDMARD IR or intolerance) trials, which both enrolled patients with ≥3 involved joints (SJC ≥3 and tender joint count [TJC] ≥3). Subgroup analysis was performed for patients with LSJ or HSJ treated with UPA 15 mg once daily (QD) or placebo (PBO). Efficacy endpoints included minimal disease activity (MDA), very low disease activity (VLDA), Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA; ≤3.2), PASDAS remission (≤1.9), and 20/50/70% improvement in American College of Rheumatology (ACR) criteria (ACR20/50/70), all at Week 24, and Psoriasis Area Severity Index (PASI) 75 and static Investigator Global Assessment of Psoriasis (sIGA) 0/1 at Week 16. Results: At baseline, patients with HSJ (n=1060) had similar demographic characteristics but tended to have higher overall disease activity than patients with LSJ across multiple disease domains (n=215; Table 1). UPA efficacy appeared comparable in patients with LSJ and HSJ, with similar proportions of patients achieving composite (MDA, VLDA, PASDAS LDA, and PASDAS remission) measures at Week 24, and skin endpoints (PASI 75 and sIGA 0/1) at Week 16 (Figure 1). At Week 24, 60.0/36.8/22.1% of patients with LSJ receiving UPA 15 mg achieved ACR20/50/70 vs 40.0/17.5/5.8% in the PBO group; rates were 70.3/49.7/26.2% (UPA 15 mg) and 36.1/15.3/3.3% (PBO) in those with HSJ. ; No Full Text

العلاقة: Annals of the Rheumatic Diseases; Annual European Congress of Rheumatology (EULAR); Gossec, L; Gladman, DD; Mcdearmon-Blondell, E; Sewerin, P; Ritchlin, CT; Feng, D; Lertratanakul, A; Ranza, R; Tam, LS; Marchesoni, A; Coates, LC; Nash, P, Efficacy of upadacitinib in patients with active psoriatic arthritis and a low or high swollen joint count: a subgroup analysis of 2 phase 3 studies (select-psa 1 and select-psa 2), Annals of the Rheumatic Diseases, 2021, 80 (Suppl 1), pp. 1308-1309; http://hdl.handle.net/10072/413965Test

الإتاحة: https://doi.org/10.1136/annrheumdis-2021-eular.2127Test
http://hdl.handle.net/10072/413965Test

المؤلفون: Strand, V, Van den Bosch, F, Ranza, R, Leung, YY, Drescher, E, Zueger, P, Saffore, CD, Lertratanakul, A, Lippe, R, Nash, P

مصطلحات موضوعية: Clinical sciences, Rheumatology and arthritis, Pharmacology and pharmaceutical sciences

الوصف: Introduction: Psoriatic arthritis (PsA) has a major impact on health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), important components in the assessment of therapeutic efficacy. We evaluated the impact of upadacitinib on PROs in PsA patients with inadequate responses or intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARD-IR). Methods: Patients enrolled in the phase 3 SELECT-PsA 2 randomized controlled trial (RCT) received 56 weeks of oral upadacitinib 15 mg QD, upadacitinib 30 mg QD, or placebo switched to either dose of upadacitinib at week 24. PROs included patient global assessment of disease activity (PtGA), pain, physical function (HAQ-DI), health-related quality of life (SF-36 physical (PCS) and mental (MCS) component summary and domain scores), fatigue (FACIT-F), psoriasis symptom severity (SAPS), and work productivity (WPAI). Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID) and scores ≥ normative values, and maintenance of improvements were assessed. Results: At weeks 12 and 24, patients treated with either upadacitinib dose reported statistically and nominally significant improvements from baseline across all PROs versus placebo (p ≤ 0.05), except the WPAI absenteeism domain, which were maintained or further improved to week 56. A significantly greater proportion of patients receiving either upadacitinib dose reported improvements ≥ MCID and scores ≥ normative values versus placebo (nominal p ≤ 0.01) in most PROs at weeks 12 and 24, with clinically meaningful improvements continuing to week 56. Improvements ≥ MCID were reported as early as week 2 in PtGA, pain, and HAQ-DI. Conclusions: Upadacitinib provides rapid, clinically meaningful, and sustained improvements in PROs reported by bDMARD-IR PsA patients. SELECT-PsA 2 ClinicalTrials.gov number, NCT03104374. ; Full Text

العلاقة: Rheumatology and Therapy; Strand, V; Van den Bosch, F; Ranza, R; Leung, YY; Drescher, E; Zueger, P; Saffore, CD; Lertratanakul, A; Lippe, R; Nash, P, Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2, Rheumatology and Therapy, 2021; http://hdl.handle.net/10072/409787Test

الإتاحة: https://doi.org/10.1007/s40744-021-00377-xTest
http://hdl.handle.net/10072/409787Test

المؤلفون: Gossec, L., Gladman, D. D., Mcdearmon-Blondell, E., Sewerin, P., Ritchlin, C. T., Feng, D., Lertratanakul, A., Ranza, R., Tam, L. S., Marchesoni, A., Coates, L. C., Nash, P.

المصدر: Annals of the Rheumatic Diseases ; volume 80, issue Suppl 1, page 1308.2-1309 ; ISSN 0003-4967 1468-2060

مصطلحات موضوعية: General Biochemistry, Genetics and Molecular Biology, Immunology, Immunology and Allergy, Rheumatology

الوصف: Background: Although most patients with psoriatic arthritis (PsA) enrolled in clinical trials have polyarticular arthritis, patients in clinical practice may present with oligoarthritis. Data on the efficacy of Janus kinase inhibitors in patients with PsA with low joint counts are limited. Objectives: To evaluate the efficacy of upadacitinib (UPA) in subgroups of patients with PsA with a low (baseline swollen joint count [SJC] <5) or high (SJC ≥5) SJC (LSJ or HSJ). Methods: Data were pooled across the SELECT-PsA 1 1 (non-biologic disease-modifying antirheumatic drug [non-bDMARD] inadequate response [IR] or intolerance) and SELECT-PsA 2 2 (bDMARD IR or intolerance) trials, which both enrolled patients with ≥3 involved joints (SJC ≥3 and tender joint count [TJC] ≥3). Subgroup analysis was performed for patients with LSJ or HSJ treated with UPA 15 mg once daily (QD) or placebo (PBO). Efficacy endpoints included minimal disease activity (MDA), very low disease activity (VLDA), Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA; ≤3.2), PASDAS remission (≤1.9), and 20/50/70% improvement in American College of Rheumatology (ACR) criteria (ACR20/50/70), all at Week 24, and Psoriasis Area Severity Index (PASI) 75 and static Investigator Global Assessment of Psoriasis (sIGA) 0/1 at Week 16. Results: At baseline, patients with HSJ (n=1060) had similar demographic characteristics but tended to have higher overall disease activity than patients with LSJ across multiple disease domains (n=215; Table 1). UPA efficacy appeared comparable in patients with LSJ and HSJ, with similar proportions of patients achieving composite (MDA, VLDA, PASDAS LDA, and PASDAS remission) measures at Week 24, and skin endpoints (PASI 75 and sIGA 0/1) at Week 16 (Figure 1). At Week 24, 60.0/36.8/22.1% of patients with LSJ receiving UPA 15 mg achieved ACR20/50/70 vs 40.0/17.5/5.8% in the PBO group; rates were 70.3/49.7/26.2% (UPA 15 mg) and 36.1/15.3/3.3% (PBO) in those with HSJ. Table 1. Baseline characteristics PBO UPA ...

الإتاحة: https://doi.org/10.1136/annrheumdis-2021-eular.2127Test

المؤلفون: Baraliakos, X., Deodhar, A., Ranza, R., Rednic, S., Ciccia, F., Ganz, F., Gao, T., Lertratanakul, A., Song, I. H., Ostor, A., Coates, L. C.

المصدر: Annals of the Rheumatic Diseases ; volume 80, issue Suppl 1, page 338-339 ; ISSN 0003-4967 1468-2060

مصطلحات موضوعية: General Biochemistry, Genetics and Molecular Biology, Immunology, Immunology and Allergy, Rheumatology

الوصف: Background: Axial, peripheral, and other disease manifestations often overlap between psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Upadacitinib (UPA) is an oral Janus kinase inhibitor under evaluation for the treatment of PsA and AS. Objectives: To describe and compare baseline characteristics and UPA efficacy across 4 subgroups of patients (pts) from clinical trials: active PsA (with/without axial involvement) and active AS (with/without peripheral involvement). Methods: Baseline characteristics and efficacy of UPA in reducing axial and peripheral signs and symptoms were assessed via an integrated analysis across the 4 pt subgroups from the SELECT-PsA 1, 1 SELECT-PsA 2, 2 and SELECT-AXIS 3 studies. Analyses of baseline characteristics included pts in the UPA 15 mg once daily (QD), UPA 30 mg QD, and placebo (PBO) groups; efficacy analyses included pts in the UPA 15 mg QD group only. Axial involvement in PsA (axial PsA) was determined by investigator assessment. Peripheral involvement in AS was defined based on presence of tender or swollen joints (TJC68 >0 or SJC66 >0), or presence of enthesitis at baseline (Maastricht Ankylosing Spondylitis Enthesitis Score >0). Results: 2102 pts (UPA 15 mg; UPA 30 mg; PBO) were evaluated across the 4 subgroups (PsA [with/without axial involvement]: 626/1289; AS [with/without peripheral involvement]: 135/52). 33% of pts with PsA had axial PsA; 72% of pts with AS had peripheral symptoms. Pts with axial PsA had higher peripheral joint (TJC68 and SJC66) and skin (psoriasis) burden than pts with AS with peripheral involvement (p<0.0001). Pts with AS with peripheral involvement had significantly greater overall pain (pt’s assessment of pain; p=0.0002) and back pain (BASDAI Q2; p<0.0001) scores, and higher total BASDAI (p=0.0076) and ASDAS (p=0.0351) scores than pts with axial PsA; physician’s global assessment of disease activity, and peripheral pain and tenderness (BASDAI Q3 and Q4) were numerically similar for these 2 subgroups (Table 1). The efficacy ...

الإتاحة: https://doi.org/10.1136/annrheumdis-2021-eular.2105Test

المؤلفون: Bredemeier, M., Duarte, A., Pinheiro, M., Stadler, B., Macieira, J. C., Ranza, R., Miranda, J., Valim, V., Castro, G., Bertolo, M., Sauma, M. D. F., Fernandes, V., Medeiros, A., Botelho, R., Brenol, C., Negrão Gonçalo Dias, D., Carvalho, H., Studart, S., Da Rocha Castelar Pinheiro, G., Rocha, L., Pereira, I., Ohira Gazzeta, M., Maria Kakehasi, A., Louzada, P., Hayata, A. L. S., Pina, F., Lupo, C., Balarini, L., Silveira, I., Kowalski, S., Titton, D., Chakr, R., Ranzolin, A., Laurindo, I., Xavier, R.

المصدر: Annals of the Rheumatic Diseases ; volume 80, issue Suppl 1, page 582.2-583 ; ISSN 0003-4967 1468-2060

مصطلحات موضوعية: General Biochemistry, Genetics and Molecular Biology, Immunology, Immunology and Allergy, Rheumatology

الوصف: Background: After failure of conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) in the therapy of rheumatoid arthritis (RA), treatment may be escalated to biologic (bDMARDs) or JAK inhibitors (JAKi) (1). Analysis of drug survival can provide useful information on the effectiveness of these therapeutic schemes. Objectives: to evaluate the association of the choice of therapeutic agent with the survival of treatment course in RA patients receiving their first bDMARD or JAKi. Methods: BiobadaBrasil is a multicentric registry-based cohort study of Brazilian patients starting their first bDMARD/JAKi (2). This analysis includes RA patients recruited from Jan 2009 to Oct 2019, followed-up over the first course of treatment with a bDMARD/JAKi until censoring (latest date, Nov 19, 2019) or occurrence of the outcome of interest. A treatment course is defined as a period during which the medication scheme does not change, except for dose adjustments. The primary outcome was the interruption of treatment course for any reason (except for pregnancy or disease remission); interruption of treatment due to adverse events (AEs) or death and due to inefficacy served as secondary outcomes. Multivariate Cox proportional hazards models were used for analyses. Results: In total, 1177 patients (3800 patient-years [PY]) were enrolled. The overall incidence of treatment interruption was 17.5/100 PY. Adalimumab was the most frequently prescribed agent, followed by infliximab (n= 267). The hazards ratios (HR) of the primary and secondary outcomes are presented in Table 1. Figure 1 compares the survival of treatment curves of different bDMARDs/JAKi. Table 1. Hazard ratios (HR) of interruption of therapy course of each therapeutic agent (the reference category for bDMARDs/ JAKi is infliximab). Results are HR, 95% CIs, and P values*. Agent (number of patients) Interruption for any reason (665 events) Interruption due to adverse events or death (196 events) Interruption due to inefficacy (319 events) Adalimumab (354) ...

الإتاحة: https://doi.org/10.1136/annrheumdis-2021-eular.3841Test

المؤلفون: Bredemeier, M., Ramos, S., Solórzano, C., Duarte, A., Pinheiro, M., Stadler, B., Macieira, J. C., Ranza, R., Miranda, J., Valim, V., Castro, G., Bertolo, M., Sauma, M. D. F., Fernandes, V., Medeiros-Ribeiro, A. C., Botelho, R., Brenol, C., Da Silveira De Carvalho, H. M., Studart, S., Da Rocha Castelar Pinheiro, G., Rocha, L., De Leon de Lima, H., Pereira, I., Ohira Gazzeta, M., Kakehasi, A., Louzada, P., Hayata, A. L. S., Pina, F., Lupo, C., Balarini, L., Silveira, I. G., Kowalski, S., Titton, D., Ranzolin, A., Xavier, R., Laurindo, I., Antonio Araujo Da Rocha Loures, M.

المصدر: Scientific Abstracts

الإتاحة: https://doi.org/10.1136/annrheumdis-2023-eular.4583Test

المؤلفون: Gladman, D. D., Starr, M., Ranza, R., Bravo Perdomo, A. M., Strauss, M., Shawi, M., Han, C., Rampakakis, E., Andrew Östör, A., Mease, P. J.

المصدر: Scientific Abstracts

الإتاحة: https://doi.org/10.1136/annrheumdis-2023-eular.1918Test