20 results on '"Thaçi, Diamant"'
Search Results
2. The contribution of joint and skin improvements to the health-related quality of life of patients with psoriatic arthritis: a post hoc analysis of two randomised controlled studies
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Kavanaugh, Arthur, Gottlieb, Alice, Morita, Akimichi, Merola, Joseph F, Lin, Chen-Yen, Birt, Julie, Shuler, Catherine L, Hufford, Matthew M, and Thaçi, Diamant
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Clinical Trials and Supportive Activities ,Arthritis ,Clinical Research ,Autoimmune Disease ,Psoriasis ,Skin ,Antibodies ,Monoclonal ,Humanized ,Arthritis ,Psoriatic ,Dermatologic Agents ,Disease Progression ,Dose-Response Relationship ,Drug ,Double-Blind Method ,Female ,Follow-Up Studies ,Humans ,Joints ,Male ,Middle Aged ,Quality of Life ,Range of Motion ,Articular ,Severity of Illness Index ,Surveys and Questionnaires ,health-related quality of life ,psoriasis ,psoriatic arthritis ,treatment ,Clinical Sciences ,Immunology ,Public Health and Health Services ,Arthritis & Rheumatology - Abstract
OBJECTIVE:Determine the contribution of joint and skin improvements to health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA). METHODS:SPIRIT-P1 and SPIRIT-P2 are phase 3 trials investigating ixekizumab, an interleukin-17A antagonist, in the treatment of patients with active PsA. Patients were randomised to ixekizumab or placebo. Outcomes included the Disease Activity Index for Psoriatic Arthritis (DAPSA), the Psoriasis Area and Severity Index (PASI), the European Quality of Life-Five Dimensions (EQ-5D) Visual Analogue Score (VAS), the 36-Item Short-Form Health Survey (SF-36) and the Work Productivity and Activity Impairment (WPAI) Questionnaire. The contribution of joint and skin improvements to HRQoL was modelled using a smoothing spline method and depicted with response surface graphics. RESULTS:In this integrated analysis, 402 patients with PsA had baseline psoriasis of ≥3% of body surface area. We applied response surface modelling to this patient data set to investigate the relationship between DAPSA, PASI and HRQoL improvements at week 24. The greatest improvement in EQ-5D VAS was associated with the largest per cent improvements in both DAPSA and PASI together, rather than DAPSA or PASI alone. Similar observations were made in domains of SF-36 and WPAI. CONCLUSION:Optimal improvements in patients' HRQoL were dependent on successful treatment of both joint and skin symptoms.
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- 2019
3. Price variability of TNF‐α inhibitor biosimilars among European countries.
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Geat, Davide, Gisondi, Paolo, Maurelli, Martina, Puig, Luis, Paul, Carle, Thaçi, Diamant, Iversen, Lars, Bellinato, Francesco, and Girolomoni, Giampiero
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PRICES ,BIOSIMILARS ,ADALIMUMAB ,SUSTAINABILITY ,PSORIATIC arthritis ,VALUE-added tax - Abstract
This article discusses the price variability of TNF-α inhibitor biosimilars for the treatment of psoriasis across European countries. The study found that there is significant price variability, with lower prices in Italy and Spain compared to Germany, France, and Denmark. The pricing policies adopted by different countries, such as mandatory discounts, progressive price discounts, and tendering or direct contracting, contribute to this variability. The findings highlight the potential impact on healthcare costs and patient access to biological treatment. However, it is important to note that the study only included one center per country. [Extracted from the article]
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- 2024
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4. Disease Characteristics and the Burden of Joint and Skin Involvement Amongst People With Psoriatic Arthritis: A Population Survey
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Tillett, William, Merola, Joseph F., Thaçi, Diamant, Holdsworth, Elizabeth, Booth, Nicola, Lobosco, L. Steve, Milligan, Gary, Hufford, Matthew M., Birt, Julie A., and Boehncke, Wolf-Henning
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- 2020
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5. Charakterisierung von Patienten mit Psoriasisarthritis in der dermatologischen und rheumatologischen Versorgung: Analyse von zwei Registern: Characterization of patients with psoriatic arthritis in dermatologic and rheumatologic care: analysis of two registries
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Augustin, Matthias, Lindner, Lisa, Kühl, Laura, Weiss, Anja, Rustenbach, Stephan Jeff, Stephan, Brigitte, Feuchtenberger, Martin, Mrowietz, Ulrich, Thaçi, Diamant, Staubach, Petra, Baraliakos, Xenofon, Strangfeld, Anja, von Kiedrowski, Ralph, Behrens, Frank, and Regierer, Anne Constanze
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Copyright of Journal der Deutschen Dermatologischen Gesellschaft is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2023
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6. Characterization of patients with psoriatic arthritis in dermatologic and rheumatologic care: analysis of two registries.
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Augustin, Matthias, Lindner, Lisa, Kühl, Laura, Weiss, Anja, Rustenbach, Stephan Jeff, Stephan, Brigitte, Feuchtenberger, Martin, Mrowietz, Ulrich, Thaçi, Diamant, Staubach, Petra, Baraliakos, Xenofon, Strangfeld, Anja, von Kiedrowski, Ralph, Behrens, Frank, and Regierer, Anne Constanze
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Summary: Background and objective: Psoriatic arthritis (PsA) is a chronic systemic inflammatory disease affecting the musculoskeletal system, skin and nails. The aim is to characterize sociodemographic and clinical patient profiles documented in dermatologic and rheumatologic care. Patients and Methods: Data of 704 patients with PsA from the dermatological Psoriasis Registry PsoBest (PB) and 1066 patients from the rheumatological disease registry RABBIT‐SpA (RS) were analyzed. Comparable anamnestic and clinical variables were identified and descriptively analyzed. Results: The mean age was 51.7 years in PB and 51.9 in RS. Disease duration of psoriasis was longer, mean cutaneous severity was higher in PB. However, more patients in RS vs. PB had tender joints and swollen joints. Mean Dermatology Life Quality Index was higher in PB and mean Health Assessment Questionnaire in RS. Patient reported global disease activity and pain were lower in PB. IL‐23 inhibitors were used more frequently in PB, and TNF inhibitors in RS. Conclusions: Clinical specialization was associated with different clinical and treatment patterns of PsA. This may indicate a selection by dominant manifestation of psoriatic disease and potentially by effects of health care access. Psoriatic arthritis should be treated in a multidisciplinary approach considering all facets of this complex disease. [ABSTRACT FROM AUTHOR]
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- 2023
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7. Paradoxical improvement of life quality in the COVID-19 era in psoriasis patients.
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Boch, Katharina, Zillikens, Detlef, Ludwig, Ralf J., and Thaçi, Diamant
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QUALITY of life ,PSORIASIS ,PSORIATIC arthritis ,STAY-at-home orders ,PSYCHOSOCIAL factors - Abstract
Background: Psoriasis is a chronic immune-mediated inflammatory disease. Beyond the physical dimensions, the disease has an extensive emotional and psychosocial effect on patients, influencing their quality of life, social life and interpersonal relationships. Thus patient-reported outcomes are a crucial instrument for the evaluation of disease burden. Navigating life in times of the COVID-19 pandemic is challenging, especially for persons suffering from chronic diseases. We here analyzed the impact of lockdown restrictions on psoriasis patients. Objective: To compare the Dermatology Life Quality Index (DLQI) before and during the COVID-19 pandemic of patients with psoriasis. Methods: Retrospective longitudinal analysis in adult patients with moderate to severe psoriasis undergoing biologic treatment between January 2020 and January 2021. DLQI, patient demographics, Psoriasis Area and Severity Index (PASI), and recent biologic treatment were recorded. Results: 103 patients were identified, of whom 19 had additional psoriatic arthritis. Female (n = 29) and male (n = 74) patients were distributed 1 to 3. Median age of patients was 54 years (range 18–85). All patients received biologic systemic treatment: anti-IL-23 (n = 39), anti-IL-17A (n = 30), anti-IL-12/23 (n = 25), or anti-TNFα (n = 9). Comparing DLQI scores before the COVID-19 pandemic and under lockdown restriction showed improved DLQI scores over time. Further analysis displayed that patients mostly ticked "not relevant" on social activities during lockdown. Thus, the DLQI scores may be artificial improved and may not really reflect the actual disease burden. Conclusions: Psoriasis patients showed a contrary improvement of life quality despite harsh COVID-19 lockdown suggesting that DLQI should be modified when social life is restricted. [ABSTRACT FROM AUTHOR]
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- 2022
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8. Drug survival of secukinumab, ustekinumab, and certolizumab pegol in psoriasis: a 2-year, monocentric, retrospective study.
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Chatzimichail, Giannis, Günther, Julia, Ständer, Sascha, and Thaçi, Diamant
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CERTOLIZUMAB pegol ,TERMINATION of treatment ,PSORIATIC arthritis ,PSORIASIS ,REGRESSION analysis - Abstract
To investigate the drug survival of secukinumab (SEC), ustekinumab (UST), and certolizumab pegol (CZP) in real-world conditions and to identify the predictors and reasons for treatment discontinuation. We performed a 2-year retrospective single-center analysis of 110 treatment courses in 98 patients with moderate to severe plaque-type psoriasis and/or psoriatic arthritis (SEC n = 68; UST n = 29; and CZP n = 13). Drug survival was examined using the Kaplan–Meier analysis and the influence of demographic factors on drug survival with Cox regression analysis. Drug survival rates at 12 and 18 months were respectively 68.5% and 59% for the entire study population, 85% and 69% for UST, 68% and 59% for SEC, and 34% for CZP. Both UST and SEC showed a significantly longer survival rate compared to CZP (p<.05), but not between each other. A total of 30 treatment discontinuations were observed, predominantly due to loss of efficacy and adverse events. Treatment selection predicted the survival rate. Other predictors could not be identified. Drug survival is the resultant of many factors such as long-term effectiveness, safety, compliance, and convenience of use. UST and SEC had higher retention rates in comparison with CZP. [ABSTRACT FROM AUTHOR]
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- 2022
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9. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial.
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Thaçi, Diamant, Strober, Bruce, Gordon, Kenneth B., Foley, Peter, Gooderham, Melinda, Morita, Akimichi, Papp, Kim A., Puig, Lluís, Menter, M. Alan, Colombo, Matthew J., Elbez, Yedid, Kisa, Renata M., Ye, June, Napoli, Andrew A., Wei, Lan, Banerjee, Subhashis, Merola, Joseph F., and Gottlieb, Alice B.
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PSORIASIS , *TREATMENT effectiveness , *BODY surface area , *PSORIATIC arthritis , *PROTEIN-tyrosine kinase inhibitors , *ORAL drug administration - Abstract
Introduction: Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis. Methods: Post-hoc analysis of a 12-week Phase 2 trial was conducted for the three most efficacious dosage groups (3 mg twice daily, 6 mg twice daily, 12 mg once daily) and placebo. Investigator assessments for efficacy included Psoriasis Area and Severity Index (PASI), body surface area (BSA) involvement, and static Physician's Global Assessment; QoL was assessed using the Dermatology Life Quality Index (DLQI). Treatment responses and their associations were evaluated over time. Results: Deucravacitinib elicited improvement versus placebo as early as Week 4 for most efficacy measures (including changes in absolute PASI and BSA), with efficacy trends observed from Week 2 to Week 12. Improvements in QoL, assessed by achievement of a DLQI overall score of 0/1 (no effect at all on patient's life), followed a pattern similar to deucravacitinib-related clinical outcomes over 12 weeks. Overall, patients with greater improvements in psoriasis-related clinical signs and symptoms also reported greater improvement in QoL. However, complete skin clearance was not required for achieving DLQI 0/1. Conclusion: Deucravacitinib treatment produced early response and similar trends in improvements across multiple efficacy assessments and QoL in moderate to severe plaque psoriasis. Deucravacitinib has the potential to become a promising new oral therapy for this condition. Trial Registration: ClinicalTrials.gov identifier; NCT02931838. Plain Language Summary: Psoriasis is a skin disease that affects up to 2% of the population. In psoriasis, red, scaly lesions develop on the skin driven by an aberrant immune response. Psoriasis impacts not only physical and mental health but also quality of life (QoL). Deucravacitinib is being investigated as a treatment for psoriasis. We performed a Phase 2 dose-ranging, placebo-controlled, 12-week study of deucravacitinib in adults with moderate to severe psoriasis. Patients in the USA, Australia, Canada, Germany, Japan, Latvia, Mexico, and Poland participated. The study showed that oral treatment with deucravacitinib was effective using a disease severity score (percentage of patients with ≥ 75% reduction from baseline in Psoriasis Area and Severity Index score) at Week 12—placebo 7% and deucravacitinib 67%–75% for the three highest dosages—and was generally well tolerated. We further analyzed the association between efficacy and a QoL measure, the Dermatology Life Quality Index (DLQI), in patients who received placebo or the most effective dosages of deucravacitinib (≥ 3 mg twice daily). Deucravacitinib was effective at the three dosage levels tested. Skin improvement occurred early during treatment and was mirrored by improvements in DLQI score during the 12 weeks of treatment. Although some patients did not have complete clearance of their psoriasis, a large percentage of those patients still achieved considerable improvement in QoL as measured by achieving a DLQI score of 0/1 (i.e., no effect at all on the patient's QoL). [ABSTRACT FROM AUTHOR]
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- 2022
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10. Long-term topical management of psoriasis: the road ahead.
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Segaert, Siegfried, Calzavara-Pinton, Piergiacomo, de la Cueva, Pablo, Jalili, Ahmad, Lons Danic, Dominique, Pink, Andrew E., Thaçi, Diamant, and Gooderham, Melinda
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PSORIASIS ,PSORIATIC arthritis ,DISEASE relapse ,EXPERT evidence ,ACQUISITION of manuscripts - Abstract
Topical therapies have been available for the treatment of psoriasis for several decades. Despite this and the availability of several types of topicals, with varying potency, and numerous vehicles of administration, the majority of clinical data and guidance is on short-term use in the management of psoriasis. The aim of this manuscript is to review the unmet needs that exist in the long-term management of psoriasis and provide the dermatology community with an understanding that a treatment regimen with topical therapies could be the best treatment option at least for some phases of this chronic relapsing disease. We present a 'call to action' on the need for clinical alignment on terminology in the field and recommend the term 'long-term management' be adopted as the most appropriate in the context of this manuscript. This expert opinion report provides a detailed review of the limited evidence available regarding long-term use of topical therapies for the management of psoriasis, alongside our key considerations and recommendations to assist dermatologists with the implementation of topicals as part of long-term management strategies. Long-term management should be considered mandatory to ensure patients receive appropriate proactive treatment which may help optimize adherence and long-term outcomes. [ABSTRACT FROM AUTHOR]
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- 2022
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11. High rates of therapeutic changes in patients with psoriatic arthritis receiving treatment with disease-modifying antirheumatic drugs: A cross-sectional study.
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Behrens, Frank, Rech, Jürgen, Thaçi, Diamant, Zinke, Silke, Rothnie, Kieran J., Daamen, Carolin (Oefner), and Leipeg, Jan
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ANTIRHEUMATIC agents ,PSORIATIC arthritis ,CROSS-sectional method - Abstract
Objectives: To characterize treatment patterns for patients with psoriatic arthritis (PsA) currently receiving any disease-modifying antirheumatic drug (DMARD). Methods: The Strategy for Psoriatic Arthritis In Germany (SPAIG) study was a retrospective observational study conducted from May to November 2017 at 46 rheumatology centers. Current and previous treatment data were collected at a single visit from adult patients with PsA and psoriasis who received DMARD treatment for ≥6 of the previous 12 months. The primary outcome was the proportion of patients receiving a biologic DMARD (bDMARD). Multinomial logistic regression analysis was used to evaluate associations between current characteristics and initial choice of therapy. Results: Mean age of the 316 patients was 55.1 years and mean PsA disease duration was 9.9 years. PsA activity was generally comparable across treatment groups. In this cohort, 57.3% of patients were currently treated with bDMARDs, 37.7% with conventional synthetic DMARDs, and 4.4% with targeted synthetic DMARDs. Almost half (48.4%) of patients reported DMARD modifications in the previous 12 months. Specific comorbidities and patient/disease characteristics were associated with initial therapy. Conclusion: DMARD treatment of PsA is frequently modified, suggesting the need for more effective therapies and assessment tools. [ABSTRACT FROM AUTHOR]
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- 2022
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12. Best-practice Indicators in Psoriatic Disease Care.
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Helliwell, Philip S., Favier, Guillaume, Gladman, Dafna D., Soriano, Enrique R., Kirkham, Bruce W., Coates, Laura C., Puig, Luis, Boehncke, Wolf-Henning, and Thaçi, Diamant
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PSORIASIS ,PSORIATIC arthritis ,HEALTH status indicators ,HEALTH outcome assessment ,MEDICAL care standards - Abstract
Objective. In 2016, members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), in collaboration with KPMG LLP (UK), conducted a study to measure care in psoriatic arthritis (PsA). A key finding was that centers do not usually have processes in place to measure the effect of improved quality of care. Our objectives were to identify and select best-practice indicators to enable PsA caregivers to assess and monitor the outcomes of specific initiatives aimed at improving care in 4 focus areas: (1) shortening time to diagnosis; (2) improving multidisciplinary collaboration; (3) optimizing disease management; and (4) improving disease monitoring. Methods. (1) Structured review of scientific and grey literature to obtain evidence for a long list of 100 potential indicators across the 4 focus areas; (2) survey expert rheumatologists and dermatologists to review the long list and identify the most meaningful and feasible indicators for use in day-to-day practice; (3) consensus discussion to identify a shortlist of indicators based on predefined selection criteria; (4) electronic group discussion to refine definitions of shortlisted indicators and targets; and (5) review of the shortlisted indicators at the annual GRAPPA meeting in July 2018 to ensure the indicators meet the preliminary criteria. Results. The expert group arrived at a consensus with a shortlist of 8 best-practice indicators across 4 key focus areas aligned with the patient pathway. Conclusion. There were 8 evidence-based best-practice indicators and respective targets that were identified to enable the monitoring of quality of care and target improvements. [ABSTRACT FROM AUTHOR]
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- 2019
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13. Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1).
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Gottlieb, Alice B, Strand, Vibeke, Kishimoto, Mitsumasa, Mease, Philip, Thaçi, Diamant, Birt, Julie, Lee, Chin H, Shuler, Catherine L, Lin, Chen-Yen, and Gladman, Dafna D
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THERAPEUTIC use of monoclonal antibodies ,ANTIRHEUMATIC agents ,HEALTH surveys ,MONOCLONAL antibodies ,HEALTH outcome assessment ,PSORIATIC arthritis ,QUALITY of life ,QUESTIONNAIRES ,RANDOMIZED controlled trials ,VISUAL analog scale ,BLIND experiment ,TREATMENT duration ,ADALIMUMAB - Abstract
Objective To report patient-reported outcomes of patients with PsA treated with ixekizumab up to 52 weeks. Methods In SPIRIT-P1, biologic-naïve patients with active PsA were randomized to ixekizumab 80 mg every 4 weeks (IXEQ4W; N = 107) or every 2 weeks (IXEQ2W; N = 103) following a 160 mg starting dose, adalimumab 40 mg every 2 weeks (ADA; N = 101) or placebo (PBO; N = 106) during the initial 24-week double-blind treatment period. At week 24 (week 16 for inadequate responders), ADA (8-week washout before starting ixekizumab) and PBO patients were re-randomized to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at week 24 received the same dose during the extension period (EP) to week 52. Patients completed measures including the Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions Visual Analogue Scale and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem. Results The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in DLQI at week 24; 22% (PBO), 53% (IXEQ4W), 63% (IXEQ2W) and 54% (ADA) of patients reported DLQI scores of 0/1. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2 physical component summary and some domain scores, and European Quality of Life 5 Dimensions Visual Analogue Scale at weeks 12 and 24; and in three of four Work Productivity and Activity Impairment Questionnaire-Specific Health Problem domains at week 24. Results are also presented through week 52 for the EP. Conclusion In biologic-naïve patients with active PsA, ixekizumab significantly improved skin symptoms, health-related quality of life and work productivity. Trial Registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239; EU Clinical Trials Register, https://www.clinicaltrialsregister.eu, EudraCT2011-002326-49 [ABSTRACT FROM AUTHOR]
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- 2018
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14. Anti-citrullinated protein antibodies are linked to erosive disease in an observational study of patients with psoriatic arthritis.
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Behrens, Frank, Koehm, Michaela, Thaçi, Diamant, Gnann, Holger, Greger, Gerd, Wittig, Bianca Maria, and Burkhardt, Harald
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BONE resorption ,CONFIDENCE intervals ,FISHER exact test ,IMMUNOGLOBULINS ,LONGITUDINAL method ,SCIENTIFIC observation ,OSTEOPOROSIS ,PSORIATIC arthritis ,RESEARCH funding ,MULTIPLE regression analysis ,DATA analysis software ,ADALIMUMAB ,DESCRIPTIVE statistics ,ODDS ratio ,MANN Whitney U Test - Abstract
Objective. ACPAs are associated with bone destruction in RA. The aim of this study was to evaluate the association between ACPA and bone destruction in patients with a distinct inflammatory disorder, PsA. Methods. We used baseline data from a large observational study of PsA patients preparing to initiate treatment with adalimumab to analyse demographic and disease characteristics by ACPA status. To ensure a homogeneous PsA study population, only patients with active psoriatic skin manifestations who met Classification of Psoriatic Arthritis criteria for PsA were included in the analyses, thereby minimizing the risk of including misdiagnosed RA patients. Multiple logistic regression analyses were used to explore potential associations between ACPA seropositivity and bone destruction. Results. Of 1996 PsA patients who met the strict inclusion criteria, 105 (5.3%) were positive for ACPA. ACPA-positive patients had significantly higher swollen joint counts and 28-joint DAS values than ACPA-negative patients and significantly higher rates of erosive changes and dactylitis. Multiple logistic regression analysis confirmed the association of ACPA seropositivity with a 2.8-fold increase in the risk of erosive disease. Conclusion. As has been previously shown for RA, ACPA is associated with bone destruction in PsA, suggesting that the osteocatabolic effect of ACPA is not confined to RA but is also detectable in the different pathogenetic context of a distinct disease entity. Trial registration: ClinicalTrials.gov, NCT01111240 [ABSTRACT FROM AUTHOR]
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- 2016
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15. Association between Skin and Joint Involvement in Patients with Psoriatic Arthritis Treated with Adalimumab: Analysis of Data from a German Non-Interventional Study.
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Thaçi, Diamant, Behrens, Frank, Greger, Gerd, Burkhardt, Harald, Gnann, Holger, Schopf, Rudolf, and Wittig, Bianca Maria
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Background: The association between skin and joint manifestations in patients with psoriatic arthritis (PsA) requires further characterization. Objective: We evaluated the association between severity of skin disease and joint involvement and the effectiveness and safety of adalimumab in PsA patients by baseline psoriasis severity. Methods: Descriptive statistics and regression analyses were used to evaluate data from 1,918 PsA patients starting adalimumab treatment. Subgroup analyses were conducted on patients empirically grouped by baseline target lesion score as a marker of psoriasis severity. Results: Psoriasis severity was not associated with joint manifestations at baseline or after 12 months of treatment. All subgroups showed improvements in skin and joints during therapy, and adalimumab was safe and well tolerated in all subgroups. Conclusion: The severity of skin manifestations does not correlate with the severity of joint disease in PsA patients; even patients with mild skin disease may have extensive musculoskeletal involvement. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]
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- 2015
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16. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics.
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Mease, Philip J., Gladman, Dafna D., Papp, Kim A., Khraishi, Majed M., Thaçi, Diamant, Behrens, Frank, Northington, Robert, Fuiman, Joanne, Bananis, Eustratios, Boggs, Robert, and Alvarez, Daniel
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Background: Prompt identification and treatment of psoriatic arthritis (PsA) in patients with psoriasis is critical to reducing the risk of joint damage, disability, and comorbidities. Objective: We sought to estimate PsA prevalence in patients with plaque psoriasis in 34 dermatology centers in 7 European and North American countries. Methods: Consecutive patients were evaluated by dermatologists for plaque psoriasis and subsequently by rheumatologists for PsA. PsA prevalence was estimated primarily based on rheumatologists' assessment of medical history, physical examination, and laboratory tests. Results: Of 949 patients evaluated, 285 (30%) had PsA (95% confidence interval 27-33) based on rheumatologists' assessment. PsA diagnosis changed in 1.2% of patients when diagnostic laboratory tests were added to medical history and physical examination. Of 285 patients given the diagnosis of PsA, 117 (41%) had not been previously given the diagnosis. Limitations: Bias may have been introduced by lack of standardized diagnostic criteria and unbalanced recruitment based on country populations. Conclusions: In this study, almost a third of patients with psoriasis seen in dermatology centers had PsA as determined by rheumatologists. More than a third of patients with PsA had not been previously given the diagnosis. Clinical evaluation alone is often sufficient basis for PsA diagnosis, but laboratory test results may be helpful in some patients. [Copyright &y& Elsevier]
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- 2013
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17. Leflunomide Improves Psoriasis in Patients with Psoriatic Arthritis: An In-Depth Analysis of Data from the TOPAS Study.
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Nash, Peter, Thaçi, Diamant, Behrens, Frank, Falk, Franziska, and Kaltwasser, J. Peter
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PSORIASIS ,SKIN diseases ,NONSTEROIDAL anti-inflammatory agents ,IMMUNOSUPPRESSIVE agents ,ARTHRITIS ,PLACEBOS - Abstract
Background: Leflunomide has shown promise in the treatment of psoriasis. Objective: To provide an in-depth analysis of the effect of leflunomide on psoriasis in patients with psoriatic arthritis (PsA). Methods: 190 patients with plaque psoriasis (at least 3% skin involvement) and active PsA were randomized to double-blind treatment with leflunomide (100 mg/day loading dose for 3 days followed by 20 mg/day orally) or placebo for 24 weeks. Results: As previously reported, leflunomide resulted in a significantly higher Psoriatic Arthritis Response Criteria response rate than placebo (58.9 vs. 29.7%; p < 0.0001). Significant differences in favor of leflunomide were also observed in the Psoriasis Area and Severity Index (PASI 50 in 30.4% of patients vs. 18.9% for placebo; p = 0.05), target lesion response (46.4 vs. 25.3%; p = 0.0048), combined skin and joint response (27.2 vs. 8.9%; p < 0.0001), Dermatology Life Quality Index (improvement of 1.9 points vs. 0.2; p = 0.0173) and certain SF-36 subdomains. Dermatological responses were observed at the earliest examination (4 weeks) and increased throughout the 24-week study. Conclusion: Once-daily oral leflunomide is an effective and convenient treatment for PsA and plaque psoriasis. Copyright © 2006 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]
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- 2006
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18. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2).
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Crowley, Jeffrey, Thaçi, Diamant, Joly, Pascal, Peris, Ketty, Papp, Kim A., Goncalves, Joana, Day, Robert M., Chen, Rongdean, Shah, Kamal, Ferrándiz, Carlos, and Cather, Jennifer C.
- Abstract
Background: Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis.Objective: Assess long-term safety of oral apremilast in psoriasis patients.Methods: Safety findings are reported for 0 to ≥156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2.Results: The 0 to ≥156-week apremilast-exposure period included 1184 patients treated twice daily with apremilast 30 mg (1902.2 patient-years). During 0 to ≤52 weeks, the adverse events (AEs) that occurred in ≥5% of patients included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. From 0 to ≥156 weeks, no new AEs (affecting ≥5% of the population) were reported. AEs, serious AEs, and study drug discontinuations caused by AEs did not increase with long-term exposure. During the 0 to ≥156-week period, the rates of major cardiac events (exposure-adjusted incidence rate [EAIR] 0.5/100 patient-years), malignancies (EAIR 1.2/100 patient-years), depression (EAIR 1.8/100 patient-years), or suicide attempts (EAIR 0.1/100 patient-years) did not increase in comparison with the rates found during the 0 to ≤52-week period. No serious opportunistic infections, reactivation of tuberculosis, or clinically meaningful effects on laboratory measurements were reported.Limitations: This study had a high dropout rate (21% of patients ongoing >156 weeks); most were unrelated to safety concerns.Conclusions: Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks. [ABSTRACT FROM AUTHOR]- Published
- 2017
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19. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE).
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Merola, Joseph F, Landewé, Robert, McInnes, Iain B, Mease, Philip J, Ritchlin, Christopher T, Tanaka, Yoshiya, Asahina, Akihiko, Behrens, Frank, Gladman, Dafna D, Gossec, Laure, Gottlieb, Alice B, Thaçi, Diamant, Warren, Richard B, Ink, Barbara, Assudani, Deepak, Bajracharya, Rajan, Shende, Vishvesh, Coarse, Jason, and Coates, Laura C
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CLINICAL trials , *PSORIATIC arthritis , *NOCEBOS , *BODY surface area , *NECROSIS - Abstract
Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A. This study compared the efficacy and safety of bimekizumab with placebo over 16 weeks in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α (TNFα) inhibitors. BE COMPLETE was a phase 3, multicentre, randomised, double-blind, placebo-controlled trial conducted across 92 sites (including hospitals, clinics, and research centres) in 11 countries (Australia, Canada, Czech Republic, Germany, Hungary, Italy, Japan, Poland, Russia, the UK, and the USA). Eligible patients were aged 18 years or older with adult-onset psoriatic arthritis (meeting the Classification Criteria for Psoriatic Arthritis for at least 6 months before screening) with a history of inadequate response or intolerance to treatment with one or two TNFα inhibitors for either psoriatic arthritis or psoriasis. We stratified patients with active psoriatic arthritis by region and previous TNFα inhibitor use. Patients were randomly assigned (2:1) to receive subcutaneous bimekizumab 160 mg every 4 weeks or placebo by an interactive-voice and web-response system on the basis of a predetermined randomisation schedule. The primary endpoint was the proportion of patients with 50% or greater improvement in American College of Rheumatology criteria (ACR50) at week 16 (non-responder imputation). Efficacy analyses were done in the randomised population. The safety analysis set comprised patients who received one or more doses of study treatment. This trial was registered at ClinicalTrials.gov , NCT03896581 , and is completed. Between March 28, 2019, and Feb 14, 2022, 556 patients were screened and 400 patients were randomly assigned to bimekizumab 160 mg every 4 weeks (n=267) or placebo (n=133). The primary and all hierarchical secondary endpoints were met at week 16. 116 (43%) of 267 patients receiving bimekizumab reached ACR50, compared with nine (7%) of 133 patients receiving placebo (adjusted odds ratio [OR] 11·1 [95% CI 5·4–23·0], p<0·0001). 121 (69%) of 176 patients with psoriasis affecting at least 3% body surface area at baseline who received bimekizumab reached 90% or greater improvement in the Psoriasis Area and Severity Index (PASI90), compared with six (7%) of 88 patients who received placebo (adjusted OR 30·2 [12·4–73·9], p<0·0001). Treatment-emergent adverse events up to week 16 were reported in 108 (40%) of 267 patients receiving bimekizumab and 44 (33%) of 132 patients receiving placebo. There were no new safety signals and no deaths. Bimekizumab treatment led to superior improvements in joint and skin efficacy outcomes at week 16 compared with placebo in patients with psoriatic arthritis and inadequate response or intolerance to TNFα inhibitors. The safety profile of bimekizumab was consistent with previous phase 3 studies in patients with plaque psoriasis, and studies of IL-17A inhibitors. UCB Pharma. [ABSTRACT FROM AUTHOR]
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- 2023
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20. A 12-point recommendation framework to support advancement of the multidisciplinary care of psoriatic arthritis: A call to action.
- Author
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Gratacós, Jordi, Behrens, Frank, Coates, Laura C., Lubrano, Ennio, Thaçi, Diamant, Bundy, Christine, de la Torre-Aboki, Jenny, Luelmo, Jesus, Voorneveld, Hanneke, and Richette, Pascal
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PSORIATIC arthritis , *PATIENT satisfaction , *CONTINUUM of care , *STRUCTURAL frames , *DISEASE complications , *DERMATOLOGISTS , *RHEUMATOLOGISTS , *PSORIASIS , *RESEARCH , *RESEARCH methodology , *MEDICAL cooperation , *EVALUATION research , *COMPARATIVE studies - Abstract
Objective: Making a differential diagnosis of psoriatic arthritis (PsA) is not straightforward. This is partly because of its heterogeneous presentation and partly because many patients with PsA are initially diagnosed with psoriasis and treated in primary care or by dermatologists, with referral to rheumatologists being delayed. Once diagnosed, optimal disease control requires frequent specialist monitoring, adjustment or switching of therapies, and management of comorbidities and concomitant diseases, as well as attention to patients' overall well-being. Given the breadth of expertise that diagnosis and management of PsA requires, we sought to define a collaborative, structured framework that supports the optimisation of multidisciplinary care for patients with PsA in Europe.Methods: An expert panel comprising four rheumatologists, three dermatologists, two specialist nurses and one psychologist-from Spain, the United Kingdom, The Netherlands, Germany, France and Italy-met face-to-face to take part in a modified Delphi exercise.Results: The result of this exercise is a set of recommendations that are based on combining published evidence with the panel's extensive clinical experience. Recommendations can be implemented in a number of ways, but the central call-to-action of this framework is the need for improved collaboration between dermatologists (or primary care physicians) and rheumatologists. This could occur in a variety of different formats: standard referral pathways, multidisciplinary physician meetings to discuss patient cases, or 'one stop', combined clinics.Conclusion: We anticipate that when the majority of patients with PsA receive regular multidisciplinary care, improved patient outcomes will follow, although robust research is needed to explore this assumption. [ABSTRACT FROM AUTHOR]- Published
- 2021
- Full Text
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