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2.
Am J Clin Dermatol ; 2020 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-31950353

RESUMO

BACKGROUND AND OBJECTIVE: The International Dermatology Outcome Measures (IDEOM) has defined a core set of domains to be measured in all psoriasis clinical trials. This set comprises the following domains: skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global, patient global, and treatment satisfaction. The next step is to define how to measure these domains. The objective of this article was to evaluate the quality of available instruments to assess 'investigator global' and 'patient global' domains to identify the most appropriate instruments. METHODS: Reviewers conducted a systematic literature review to retrieve studies on the measurement properties of instruments including either an investigator global assessment or a patient global assessment. Following the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, three independent reviewers rated the quality of each study. We then performed a qualitative synthesis of the evidence. RESULTS: We identified nine investigator global assessments and three patient global assessments, reflecting substantial variability in global assessment instruments. Overall, most measures lacked evidence for content validity and feasibility. The Lattice System-Physician Global Assessment, Product of the Investigator Global Assessment and Body Surface Area, and the professional-Simplified Psoriasis Index had higher levels of evidence for validity, reliability, and/or responsiveness than the 5- and 6-point investigator global assessments. The self-assessment-Simplified Psoriasis Index was the only patient global assessment with evidence for validity, reliability, and responsiveness. CONCLUSIONS: The 5- and 6-point investigator global assessments, which are the most widely used investigator global assessments in registered clinical trials, have less evidence for measurement properties as compared with the Lattice System-Physician Global Assessment, professional-Simplified Psoriasis Index, and the Product of the Investigator Global Assessment and Body Surface Area. However, all instruments lack evidence for content validity and feasibility. Further validation studies of investigator global assessments and patient global assessments are required to recommend the best global measure for psoriasis clinical trials.

3.
J Am Acad Dermatol ; 82(1): 54-61, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31163240

RESUMO

BACKGROUND: The International Dermatology Outcome Measures established a set of core domains to be measured in all psoriasis trials. This set requires that symptoms of psoriatic arthritis (PsA) be measured in all psoriasis studies. OBJECTIVE: To identify the approach to PsA screening and the most appropriate outcome measure for capturing PsA symptoms. METHODS: Following guidelines (ie, the COnsensus-based Standards for the selection of health Measurement INstruments, Core Outcome Measures in Effectiveness Trials Initiative, and Outcome Measures in Rheumatology Handbook), we conducted a consensus-building study that included patients, physicians, industry partners, and patient association representatives. The process consisted of a literature review and quality appraisal of measures for PsA symptoms, a pre-Delphi exercise, a Delphi survey, and a consensus meeting. RESULTS: Among the 297 expert participants in the Delphi survey, 87.5% agreed that all patients in a psoriasis trial should be screened for PsA with a validated screening tool. Regarding the measurement of PsA symptoms, the preferred instrument was the Psoriatic Arthritis Impact of Disease-9 (PsAID9), with the Routine Assessment Patient Index Data-3 (RAPID3) representing an acceptable alternative. LIMITATIONS: Only International Dermatology Outcome Measures members participated in the consensus meeting. CONCLUSION: The overwhelming majority of expert stakeholders agreed that all psoriasis trial participants should be screened for PsA, with PsA symptoms measured by using PsAID9 (or alternatively with RAPID3).

4.
Br J Neurosurg ; : 1-4, 2019 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-31805794

RESUMO

Background: Idiopathic intracranial hypertension (IIH) is a condition affecting predominantly young women with increased body mass index (BMI). Obesity with the related metabolic and biochemical complications are thought to be involved in the pathogenesis of the condition. The aim of this study is to evaluate the safety, outcomes and economic implications of two treatment options for IIH.Methods: We retrospectively analysed cases of morbidly obese IIH patients treated by cerebrospinal fluid (CSF) shunting procedures between 2006 and 2016 in our department and compared their outcome with that of 69 patients undergoing bariatric surgery between 2015 and 2016.Results: A total of 42 female patients with IIH underwent de-novo shunting procedures during the study period. There was a high rate of shunt revisions (67%) and further weight gain in the majority of patients who had the insertion of CSF shunts. Of the 69 female patients undergoing bariatric surgery 4.3% required interventions related to their surgery with a significantly fewer number of hospital inpatient days. Furthermore, in the patients undergoing bariatric surgery, there was a significant improvement in all obesity-related complications.Conclusions: CSF shunting procedures do not address the aetiological factor of IIH and are associated with high rates of morbidity and further weight gain. Bariatric surgery is not only efficacious in the management of patients with IIH but is associated with significant improvements in other obesity-related comorbidities. Bariatric surgery is safe and more cost-effective than CSF shunting.

5.
Artigo em Inglês | MEDLINE | ID: mdl-31628721

RESUMO

OBJECTIVE: Individuals with systemic lupus erythematosus (SLE) are at high risk for infections, SLE- and medication-related complications. We defined a set of SLE-specific adverse outcomes that could be prevented, or their complications minimized, if timely, effective ambulatory care had been received. METHODS: We used a modified Delphi process beginning with a literature review and key informant interviews to select initial SLE-specific potentially preventable conditions. We assembled a panel of sixteen nationally-recognized U.S.-based experts from eight subspecialties. Guided by the RAND-UCLA Appropriateness Method, we held two survey rounds with controlled feedback and an interactive webinar to reach consensus regarding preventability and importance on a population level for a set of SLE-specific adverse conditions. In a final round, the panelists endorsed the potentially preventable conditions. RESULTS: Thirty-five potential conditions were initially proposed; 62 conditions were ultimately considered during the Delphi process. The response rate was 100% for both survey rounds, 88% for the webinar, and 94% for final approval. The 25 SLE-specific conditions meeting consensus as potentially preventable and important on a population level fell into four categories: vaccine-preventable illnesses (6 conditions), medication-related complications (8), reproductive health-related complications (6) and SLE-related complications (5). CONCLUSIONS: We reached consensus on a diverse set of adverse outcomes relevant to SLE patients that may be preventable if patients received high quality ambulatory care. This set of outcomes may be studied at the health system level to determine how to best allocate resources and improve quality to reduce avoidable outcomes and disparities among those at highest risk.

6.
J Am Acad Dermatol ; 2019 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-31525439

RESUMO

BACKGROUND: The International Dermatology Outcome Measures and the American Academy of Dermatology recently agreed on a physician-reported global severity measure to demonstrate quality of care in inflammatory dermatoses. Because patient-reported outcome measures (PROMs) are also important, we aimed to achieve consensus on a PROM for clinical practice. METHODS: Patients and providers participated in a consensus-building study using a modified-Delphi technique. Voting focused on identifying: (i)minimal set of assessments for clinical practice; (ii)patient-global assessments (PtGAs); (iii)Skindex instruments; and (iv)final instrument selection for quality improvement. RESULTS: Among 53 stakeholders, >70% agreed that identification of patient goals, assessment of treatment harm and assessment of the adequacy of treatment response were the minimal assessments for clinical practice. The most preferred PtGA was a 5-point PtGA (0=clear to 4=severe) with an optional check-box: "worst ever". A new metric assessing change since treatment initiation called "trajectory measure" was proposed. Stakeholders preferred Skindex instruments over PtGAs and a trajectory measure for clinical practice. CONCLUSIONS: PtGAs as standalone measures do not adequately capture the patient's assessment of disease severity or impact of care. The combination of PtGAs with Skindex or other measure of health-related quality of life may provide a more comprehensive evaluation of patients in clinical practice.

7.
Medchemcomm ; 10(8): 1391-1398, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-31534656

RESUMO

A new class of piano-stool iridium complexes with 1,2-diaminoethane ligands are shown to be effective and safe antimicrobials with activity against Staphylococcus aureus, including various isolates of methicillin-resistant strains (MRSA). Comparison to other piano stool complexes with activity against mycobacteria are made along with a discussion of structure-activity relationships. The structures of one the most active complexes with the ligand cis-1,2-diaminocyclohexane and one of the least active complexes with the ligand trans-1,2-diaminocyclohexane are compared and discussed with respect to their drastically different activities. In vitro toxicity studies for all of the complexes are described. In addition, a mouse study with one of the complexes, [(pentamethylcyclopentadienyl)(cis-1,2-diaminocyclohexane)(chloro)iridium]chloride, showed no ill effects on the mice at high doses.

8.
Am J Clin Dermatol ; 2019 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-31452091

RESUMO

Elderly patients are a group with a high frequency of psoriasis. Their disease burden has negative impacts on their quality of life. While there is a clear need to treat these patients, there are challenges in doing so. This work seeks to define the challenges that exist in treating elderly Medicare patients, as well as to provide treatment suggestions for providers to follow if they encounter one or more of these challenges. Providers face the following challenges when creating treatment plants for elderly patients with psoriasis: difficulty in obtaining drug coverage through Medicare, increased medical comorbidities, and polypharmacy. Providers aim for regimens that are affordable, safe, and efficacious, but it is not always clear how to achieve this combination, especially in elderly Medicare patients. This work is relevant in that it aims to explain the logistical roadblocks posed by Medicare coverage and provide solutions for commonly encountered issues in the treatment of a disabling and common disease in a high-risk population. Specifically, alternative treatment options to biologics and small-molecule inhibitors are discussed and include topical therapies, phototherapy, methotrexate, acitretin, and cyclosporine and for psoriatic arthritis include corticosteroids and leflunomide. The specific risks and benefits of these therapies in the elderly population are provided, allowing providers to make patient-specific decisions about optimal regimens.

9.
J Rheumatol ; 2019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-31308213

RESUMO

OBJECTIVE: Fatigue is one of the most significant symptoms, and an outcome of great importance, in patients with psoriatic arthritis (PsA), but associations between underlying components of fatigue experienced by patients in relation to the disease have been sparsely investigated. The objectives were to describe the degree of fatigue in patients with PsA, and to examine important components associated with fatigue. METHODS: We performed a cross-sectional survey including patients registered in the Danish nationwide registry DANBIO from December 2013 to June 2014. Principal component analysis (PCA) was used to identify factors associated with fatigue. RESULTS: A total of 1062 patients with PsA were included in the study. A PCA reduced co-variables into 3 components explaining 63% of fatigue in patients. The first component, contributing to 31% of fatigue, was composed of inflammatory factors including swollen and tender joints, physician's global assessment, elevated C-reactive protein (CRP), and high Pain Detect Questionnaire (PDQ) score. The second component, contributing to 17% of fatigue, consisted of increasing age and long disease duration. The third component, contributing to 15% of fatigue, consisted of high PDQ score, tender joint count, increasing age, and concomitant low CRP, suggestive of a chronic pain component consisting of central pain sensitization or structural joint damage. CONCLUSION: Fatigue in patients with PsA may be driven by clinical inflammatory factors, disease duration, and chronic pain in the absence of inflammation.

10.
J Am Acad Dermatol ; 2019 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-31158390

RESUMO

BACKGROUND: Severe atopic dermatitis (AD) is increasingly treated with systemic immuno-modulatory drugs yet their safety is unclear. OBJECTIVE: We evaluated the comparative risk of serious bacterial and opportunistic infections among users of systemic immuno-modulatory medications in patients with severe AD in routine care. METHODS: In a population-based claims data study we identified adult patients with AD who were treated with systemic drugs. The incidence of serious bacterial and opportunistic infections leading to hospitalization was computed using ICD diagnosis codes. Relative risks were computed after 1:1 propensity score matching. RESULTS: Up to 232,611 patients with AD were eligible. The incidence of serious infections was 7.53 per 1,000 (7.18-7.89) among systemic non-biologics and 7.38 per 1,000 (5.68-9.57) among phototherapy treated patients, and 2.6 per 1,000 (0.45-14.3) dupilumab users. After matching, compared to methotrexate, cyclosporine had significantly reduced 6-month risk (RR=0.87), while prednisone, azathioprine and mycophenolate showed increased risks (RR= 1.78, 1.89 and 3.31, respectively). Small numbers of dupilumab users showed no increase in risk (RR=0.33; 0.03 - 3.20). CONCLUSION: In this population-based study of adult AD patients, cyclosporine and methotrexate have the lowest 6-month risks of serious infections. Increased risks were observed for prednisone, azathioprine, and mycophenolate relative to methotrexate.

11.
J Rheumatol Suppl ; 95: 28-32, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31154401

RESUMO

At the 2018 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the International Dermatology Outcome Measures (IDEOM) Psoriasis Working Group presented an overview of its efforts to enhance clinical care and research in both the clinical setting as well as in clinical trials for psoriasis. First, the group discussed the results of a Delphi survey conducted in collaboration with the American Academy of Dermatology to agree on a unique physician-reported global assessment to measure the quality of care delivered to patients with psoriasis and other chronic inflammatory dermatoses. Second, the group summarized its efforts to select outcome measures for "PsA symptoms" and "treatment satisfaction," 2 of the domains of the psoriasis core domain set that were established by IDEOM. Finally, the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN) presented an update on its clinical, educational, and research missions to foster the development of combined clinics for psoriatic disease, increase disease awareness, and accelerate management.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Satisfação do Paciente , Psoríase/tratamento farmacológico , Pele/patologia , Artrite Psoriásica/patologia , Dermatologia , Humanos , Psoríase/patologia , Reumatologia
12.
Dermatology ; 235(4): 348-354, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31141807

RESUMO

BACKGROUND/AIMS: In the treat-to-target era, psoriasis disease activity measures that can be easily performed in routine clinical practice are needed. This retrospective pooled analysis explored cutoff values of the product of the 5-point Investigator's Global Assessment and percentage of affected body surface area (IGA × BSA) correlating with achievement of minimal disease activity (MDA). METHODS: Post hoc analysis of the phase 3 clinical trials ERASURE, FIXTURE, FEATURE, and JUNCTURE was conducted to determine associations between IGA × BSA and 2 MDA definitions (Psoriasis Area and Severity Index [PASI] 90 and Dermatology Life Quality Index [DLQI] 0/1, or PASI score ≤1 or BSA <3%) in patients with moderate-to-severe psoriasis receiving secukinumab 300 mg. For each definition of MDA, a range of possible cutoff values of IGA × BSA was examined at each time point. The optimal cutoff value was determined using Youden index (YI), calculated as (sensitivity + specificity - 1). RESULTS: For MDA defined as PASI 90 and DLQI 0/1, optimal IGA × BSA cutoffs were 2.10 at week 12 (YI, 0.60; sensitivity, 0.78; specificity, 0.82), 1.02 at week 24 (YI, 0.55; sensitivity, 0.73; specificity, 0.82), and 1.00 at week 52 (YI, 0.65; sensitivity, 0.79; specificity, 0.86). For MDA defined as PASI score ≤1 or BSA <3%, optimal IGA × BSA cutoffs were 2.98 at week 12 (YI, 0.91; sensitivity, 0.99; specificity, 0.92), 2.80 at week 24 (YI, 0.94; sensitivity, 0.99; specificity, 0.95), and 3.00 at week 52 (YI, 0.96; sensitivity, 1.00; specificity, 0.96). CONCLUSION: IGA × BSA could be a valid measure highly associated with achievement of MDA.

13.
Ann Rheum Dis ; 78(9): 1215-1219, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31113794

RESUMO

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.

14.
J Psoriasis Psoriatic Arthritis ; 4(2): 70-80, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31093599

RESUMO

Tumor necrosis factor a (TNF-α)-targeted therapies have expanded the therapeutic options for patients with inflammatory bowel disease (IBD), rheumatoid arthritis (RA), psoriasis, and psoriatic arthritis (PsA) and have significantly improved patients' quality of life. Paradoxically, anti-TNF-α agents may induce psoriatic eruptions or worsen preexisting psoriatic skin disease. Currently, there is no standard approach for the management of TNF inhibitor-induced psoriasis. Here, we conduct a literature review on TNF inhibitor-induced psoriasis and introduce a novel treatment algorithm for maintaining otherwise effective anti-TNF therapy versus switching to a different class as appropriate in the management of patients with IBD, RA, psoriasis, or PsA.

15.
J Dermatolog Treat ; : 1-18, 2019 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-31014154

RESUMO

Psoriatic arthritis (PsA) affects up to one-third of patients with psoriasis. It is the major comorbidity of psoriasis because of the likelihood that loss of function and permanent disability will develop if initiation of treatment is delayed. Dermatologists are uniquely positioned to recognize early signs of PsA and be the first-line healthcare practitioners to detect PsA in patients with psoriasis. PsA can affect six clinical domains: peripheral arthritis, dactylitis, enthesitis, psoriasis, psoriatic nail disease, and axial disease. However, not every patient will have involvement of all domains and the domains affected can change over time. Complicating the diagnosis is the condition's similarity with other arthritic diseases and potential heterogeneity. In this article, we provide practical guidance for dermatologists for detecting PsA in patients with psoriasis. We also review the available treatment options by each clinical domain of PsA and give advice on how to interpret the results of PsA clinical trials. Through early recognition of PsA in patients with psoriasis and initiation of proper treatment, dermatologists can help to prevent PsA disease progression, irreversible joint damage, and resultant permanent disability, and improve quality of life.

16.
J Am Acad Dermatol ; 81(1): 102-110, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30885757

RESUMO

BACKGROUND: Herpes zoster (HZ) incidence is linked to immunosuppression. Patients with psoriasis or psoriatic arthritis (PsA) on systemic therapy might be at an increased risk for HZ. OBJECTIVE: To assess HZ risk in patients with psoriasis and PsA by systemic treatment and provide recommendations regarding HZ vaccination. METHODS: A systematic literature search was performed for HZ in patients with psoriasis and PsA. HZ vaccination guidelines were reviewed, and the medical board of the National Psoriasis Foundation made consensus recommendations in psoriasis and PsA patients using graded evidence. RESULTS: In total, 41 studies met inclusion criteria. Systemic corticosteroids (strong, 1), tofacitinib (strong, 1), and combination therapy with biologic and conventional synthetic disease-modifying antirheumatic drugs (weak, 2a) carry increased HZ risk while monotherapy does not. There is insufficient evidence to determine risk with interleukin 12/23, 17, and 23 inhibitors or apremilast (weak, 2a). Recombinant zoster vaccine is recommended for all psoriasis and PsA patients >50 years old and patients <50 years old on tofacitinib, systemic steroids, or combination systemic treatment. Vaccination of patients <50 years old on other systemic therapies may be considered on a case-by-case basis. LIMITATIONS: There was significant heterogeneity between studies. CONCLUSION: HZ risk depends on disease severity and treatment class. Recombinant zoster vaccine should be given to all psoriasis and PsA patients >50 years old and younger patients at increased risk.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Vacina contra Herpes Zoster/administração & dosagem , Herpes Zoster/prevenção & controle , Psoríase/tratamento farmacológico , Psoríase/imunologia , Adulto , Antirreumáticos/uso terapêutico , Artrite Psoriásica/epidemiologia , Artrite Psoriásica/imunologia , Feminino , Herpes Zoster/epidemiologia , Herpes Zoster/imunologia , Humanos , Hospedeiro Imunocomprometido , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Prognóstico , Psoríase/epidemiologia , Medição de Risco , Sociedades Médicas , Resultado do Tratamento , Estados Unidos , Vacinação/métodos
18.
Nat Rev Rheumatol ; 15(3): 153-166, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30742092

RESUMO

Psoriasis is one of the most common chronic inflammatory skin diseases, affecting 3% of the world's population, and approximately one-third of patients with psoriasis will eventually transition to having psoriatic arthritis (PsA). The evolution from cutaneous to synovio-entheseal inflammation in these patients presents an opportunity to investigate the critical events linked to arthritis development. The events responsible for progression to PsA are currently unclear. Genetic and clinical-demographic risk factors (most notably familial aggregation and psoriasis sub-phenotypes) provide relevant insights into the variables that promote transition. The specific underlying molecular and cellular mechanisms, however, remain poorly defined. Intriguingly, although targeting the IL-23-IL-17 axis substantially improves psoriasis outcomes, this strategy is not more effective than TNF inhibitors in improving musculoskeletal symptoms in PsA. Major unmet needs in the field of PsA include defining those patients with psoriasis at increased risk of developing arthritis, improving our understanding of the natural history of disease and characterizing the immune, environmental and molecular subclinical events preceding PsA onset. Improving our knowledge of this transition is essential for designing clinical trials with treatments that can delay, attenuate or even prevent the development of PsA in patients with psoriasis.

19.
J Clin Invest ; 129(3): 1359-1371, 2019 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-30645203

RESUMO

BACKGROUND: Plasmacytoid DCs (pDC) produce large amounts of type I IFN (IFN-I), cytokines convincingly linked to systemic lupus erythematosus (SLE) pathogenesis. BIIB059 is a humanized mAb that binds blood DC antigen 2 (BDCA2), a pDC-specific receptor that inhibits the production of IFN-I and other inflammatory mediators when ligated. A first-in-human study was conducted to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single BIIB059 doses in healthy volunteers (HV) and patients with SLE with active cutaneous disease as well as proof of biological activity and preliminary clinical response in the SLE cohort. METHODS: A randomized, double-blind, placebo-controlled clinical trial was conducted in HV (n = 54) and patients with SLE (n = 12). All subjects were monitored for adverse events. Serum BIIB059 concentrations, BDCA2 levels on pDCs, and IFN-responsive biomarkers in whole blood and skin biopsies were measured. Skin disease activity was determined using the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A). RESULTS: Single doses of BIIB059 were associated with favorable safety and PK profiles. BIIB059 administration led to BDCA2 internalization on pDCs, which correlated with circulating BIIB059 levels. BIIB059 administration in patients with SLE decreased expression of IFN response genes in blood, normalized MxA expression, reduced immune infiltrates in skin lesions, and decreased CLASI-A score. CONCLUSIONS: Single doses of BIIB059 were associated with favorable safety and PK/PD profiles and robust target engagement and biological activity, supporting further development of BIIB059 in SLE. The data suggest that targeting pDCs may be beneficial for patients with SLE, especially those with cutaneous manifestations. TRIAL REGISTRATION: ClinicalTrials.gov NCT02106897. FUNDING: Biogen Inc.

20.
Rheumatol Ther ; 6(1): 33-45, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30610650

RESUMO

INTRODUCTION: Psoriatic arthritis (PsA) and psoriasis (PsO) have a significant impact on HRQOL and work productivity loss. In patients with both PsA and PsO, the full extent of the physical and emotional burden of joint- and skin-related symptoms is less understood from the patient perspective. METHODS: A cross-sectional study of PsO patients with PsA from the US, France, and Germany was conducted using an online survey. Data on demographics, PsO severity by patient-reported body surface area involvement (BSA), PsA severity by RAPID3, impact of PsO and PsA using Patient Global Assessment (1-5), and novel questions exploring the emotional burden of joint/skin-related symptoms were collected. Multivariate regression analyses examined severity of joint and skin symptoms as predictors of quality of life (QoL), measured by PsAQoL, and Work Productivity and Activity Impairment (WPAI). RESULTS: Of the 439 patients, 23.9% had mild (RAPID3 of 0-2) and 76.1% had moderate-severe PsA (RAPID3 of 2.1-10), while 51% had mild and 49% had moderate-severe PsO (≥ 3 palms of the hand for BSA). Multivariate analyses showed that severity of joint symptoms was strongly associated with lower QoL (t = 13.15), followed by impact of skin symptoms (t = 5.11), and age (t = - 4.73), all p < 0.0001. About 57% of all patients reported a DLQI > 5, indicating a moderate-to-extremely large effect of psoriasis on HRQoL. Joint severity and impact of joint symptoms were the strongest predictors of WPAI. Patients also associated skin and/or joint symptoms with a variety of emotions and QoL measures that were not captured on the validated scales (fatigue, how they think of themselves, how others thought of them, making a first impression etc.). CONCLUSIONS: In this study, both skin and joint symptoms had a broad, meaningful impact on patient QoL, work productivity, daily activities, and emotional well-being. These data highlighted the unique and significant impact of PsA among patients with PsO. FUNDING: Eli Lilly and Company.

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