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1.
Artigo em Inglês | MEDLINE | ID: mdl-33822898

RESUMO

OBJECTIVE: To further characterize the effect of guselkumab, a selective interleukin-23p19-subunit inhibitor approved for psoriatic arthritis (PsA), on enthesitis and assess relationships between enthesitis resolution and patient status/outcomes. METHODS: Adults with active PsA despite standard therapies in the Phase-3 DISCOVER-1 and DISCOVER-2 studies were randomized 1:1:1 to guselkumab 100 mg every-4-weeks (Q4W); guselkumab 100 mg at Week0, Week4, Q8W; or placebo through Week20 followed by guselkumab 100 mg Q4W (Placebo→Q4W). Independent assessors evaluated enthesitis using the Leeds Enthesitis Index (LEI; total score 0-6). Enthesitis findings through Week24 were prespecified to be pooled across studies; post hoc and Week52 analyses also employed pooled data. RESULTS: Among 1,118 randomized, treated patients in DISCOVER-1 and 2 who had ≥1LEI site evaluated, 65% had enthesitis at baseline. These patients exhibited numerically more swollen and tender joints, systemic inflammation, and impaired physical function than patients without enthesitis. Guselkumab Q4W and Q8W were superior to placebo in resolving pre-existing enthesitis at Week24 (45% and 50% vs 29%; both adjusted p= 0.0301). Enthesitis resolution rates continued to rise; 58% of guselkumab-randomized patients achieved resolution at Week52, including patients with mild (LEI = 1; 70-75%), moderate (LEI = 2; 69-73%), or severe (LEI = 3-6; 42-44%) enthesitis at baseline. Among guselkumab-randomized patients with resolved enthesitis at Week24, 42% achieved minimal disease activity at Week52, vs 17% of patients with unresolved enthesitis. CONCLUSION: Guselkumab resulted in higher proportions of PsA patients with resolved enthesitis by Week24, with maintenance of resolution rates through 1 year. As enthesitis confers greater disease burden, sustained resolution could portend better patient outcomes. CLINICAL TRIAL REGISTRATION: DISCOVER 1 (NCT03162796) and DISCOVER 2 (NCT03158285).

2.
Arthritis Rheumatol ; 2021 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-33682378

RESUMO

OBJECTIVE: To evaluate the effect of withdrawing ixekizumab in patients with psoriatic arthritis (PsA) who had achieved minimal disease activity (MDA) after open-label ixekizumab treatment. METHODS: SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study that enrolled biologic-naive adult patients with PsA to open-label ixekizumab (160 mg at week 0, 80 mg every two weeks [IXE Q2W]) for 36 weeks. Patients sustaining MDA for >3 consecutive months were randomized (between weeks 36-64) 1:1 to blinded IXE Q2W withdrawal (placebo) or continued IXE Q2W treatment up to week 104. The primary efficacy endpoint was time to relapse (loss of MDA) for randomized patients. Patients who relapsed were retreated with IXE Q2W until week 104. RESULTS: A total of 394 patients were enrolled and received open-label IXE Q2W. Of those, 158 (40%) patients achieved sustained MDA and were randomized to IXE Q2W withdrawal (placebo; N=79) or continued IXE Q2W treatment (N=79). Patients relapsed more rapidly with treatment withdrawal (median 22.3 weeks [95% CI 16.1-28.3]) vs continued IXE Q2W treatment (median not estimable, p<0.0001); 67 (85%) patients vs 30 (38%) patients relapsed, respectively. Median time to re-achieving MDA on retreatment was 4.1 weeks (95% CI 4.1-4.3); 64 (96%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment. Safety was consistent with the known safety profile for ixekizumab. CONCLUSION: Continued ixekizumab therapy is superior to ixekizumab withdrawal in maintaining low disease activity in biologic-naive patients with PsA. Retreatment with ixekizumab following relapse may restore disease control in case of treatment interruption.

3.
J Rheumatol ; 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33649067

RESUMO

This article summarizes sessions that dealt with axial psoriatic arthritis (axPsA) at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2020 virtual meeting. The summary includes the symposium, which comprised a plenary presentation by Dr. Dafna Gladman from Toronto, Canada, as well as a panel discussion with Dr. Philip Helliwell, Dr. Denis Poddubnyy, and Dr. Gladman, moderated by Dr. Philip Mease. In addition, the paper also summarizes Dr. Mease's "Meet the Expert" session, which focused on axPsA.

4.
J Rheumatol ; 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-33649070

RESUMO

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Working Group provided updates at the 2020 GRAPPA annual meeting on its work toward developing a core outcome set for PsA. Working groups were set up for the 4 prioritized domains: enthesitis, fatigue, structural damage, and physical function. Two instruments for measurement of physical function were provisionally endorsed: (1) the Health Assessment Questionnaire-Disability Index and (2) the physical functioning domain in the Medical Outcomes Study 36-item Short Form survey.

5.
J Rheumatol ; 2021 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-33722939

RESUMO

Pustular psoriasis (PsO) is an uncommon variant of PsO that may present in a generalized or localized fashion with or without musculoskeletal or systemic inflammatory involvement. Generalized pustular PsO (GPP) presents as a widespread acute or subacute pustular eruption that may be familial and is often associated with severe flares and systemic inflammation. The palmoplantar pustulosis variant is localized to palms and soles, whereas acrodermatitis continua of Hallopeau is localized to the nail apparatus. Patients with pustular PsO may have overlapping plaque PsO and may develop psoriatic arthritis (PsA). Pustulosis is also a feature of both synovitis, acne, pustulosis, hyperostosis, osteomyelitis (SAPHO) syndrome and chronic nonbacterial osteomyelitis. At the 2020 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting, members were given an overview of the cutaneous features of pustular PsO, SAPHO, and recent insights into the genetics of GPP, leading to new targeted drug therapies and the development of validated endpoints.

6.
J Rheumatol ; 2021 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-33722941

RESUMO

At the 2020 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the International Dermatology Outcome Measures (IDEOM) Initiative Psoriasis (PsO) Working Group presented an update on its work to agree on meaningful, valid, and feasible outcome measures for PsO randomized controlled trials and longitudinal observational studies. The Treatment Satisfaction Working Group presented the development of a treatment satisfaction instrument to be utilized in PsO clinical trials. The Musculoskeletal Symptoms Working Group presented an overview of their work conducted to date to define how to best measure musculoskeletal symptoms in PsO clinical studies, and discussed next steps during an open-panel discussion, which included PsO and psoriatic arthritis experts.

7.
J Rheumatol ; 2021 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-33722951

RESUMO

The coronavirus disease 2019 (COVID-19; caused by SARS-CoV-2) pandemic has affected the healthcare system on a global scale, and we utilized the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2020 annual meeting to examine how COVID-19 might affect patients with psoriatic disease (PsD) and the clinicians who care for them. Pressing issues and concerns identified included whether having psoriasis increased the risk of acquiring COVID-19, vaccine safety, and the acceptability of telehealth. The general message from rheumatologists, dermatologists, infectious disease specialists, and patient research partners was that data did not suggest that having PsD or its treatment significantly increased risk of infection or more severe disease course, and that the telehealth experience was a success overall.

8.
J Rheumatol ; 2021 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-33589560

RESUMO

In response to the travel restrictions due to the COVID-19 (coronavirus disease 2019; caused by SARS-CoV-2) pandemic and recognizing that virtual meetings and symposia may play an important role in 2021, the education committee reviewed future directions and ideas for virtual symposia over a wide diversity of topics.

9.
Med Clin North Am ; 105(2): 325-339, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33589106

RESUMO

Spondyloarthritis is a common rheumatologic disease, present in up to 2% of the population, characterized by inflammatory arthritis, often with enthesitis, dactylitis, spondylitis, and skin disease. It has historically been characterized as ankylosing spondylitis, psoriatic arthritis, arthritis associated with inflammatory bowel disease, reactive arthritis, and undifferentiated spondyloarthritis. These subsets are now classified as axial-predominant and peripheral-predominant spondyloarthritis. This article provides an updated understanding of disease classification and practical advice about diagnosis to aid in the determination of which patients should be referred to rheumatology. It is important to provide patients the opportunity to have early and effective therapy.


Assuntos
Administração dos Cuidados ao Paciente/métodos , Espondilartrite , Diagnóstico Diferencial , Intervenção Médica Precoce , Humanos , Encaminhamento e Consulta , Reumatologia/métodos , Espondilartrite/diagnóstico , Espondilartrite/fisiopatologia , Espondilartrite/terapia
10.
RMD Open ; 7(1)2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33452180

RESUMO

OBJECTIVES: We examined patient-reported outcomes (PROs) in The Study of Etanercept And Methotrexate in Patients with Psoriatic Arthritis (PsA); a 48-week, phase 3, randomised controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept monotherapy, and MTX+ etanercept in patients with PsA. METHODS: Efficacy endpoints included: mean changes from baseline and proportion of patients who reported improvements≥minimal clinically important difference (MCID) at week 24 in treatment groups for Health Assessment Questionnaire-Disability Index, Patient Global Assessment (PtGA), Patient Global Assessment of Joint Pain (PtGAJP) and Medical Outcomes Study Short Form-36 Questionnaire (SF-36) Physical Component Summary (PCS), and Mental Component Summary, and eight domain scores. PROs were analysed as reported (observed), without multiplicity adjustment; therefore, p values are descriptive. RESULTS: At week 24, patients receiving etanercept monotherapy or MTX+ etanercept combination reported greater improvements (p≤0.05) in PtGA, PtGAJP and SF-36 PCS scores compared with those receiving MTX monotherapy. Compared with MTX monotherapy, higher proportions of patients receiving etanercept monotherapy and combination therapy reported improvements≥MCID in PtGA (etanercept vs MTX, p=0.005) and PtGAJP (MTX +etanercept vs MTX, p=0.038). Across PROs, proportions of patients reporting scores≥age and gender-matched normative values at week 24 ranged from 20.8% to 51.0% with MTX monotherapy, 30.9% to 48.8% with etanercept monotherapy, and 30.6% to 52.3% with MTX+ etanercept combination. CONCLUSIONS: Patients receiving etanercept monotherapy or MTX+ etanercept reported greater improvements from baseline in several PROs compared with those receiving MTX monotherapy. PROs should be incorporated in discussions between patients and clinicians regarding their treatment choices as they can help determine which treatments are more beneficial in patients with PsA.

12.
Ann Rheum Dis ; 2020 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-33272960

RESUMO

BACKGROUND: Upadacitinib is a Janus kinase inhibitor under evaluation for the treatment of psoriatic arthritis (PsA). We evaluated upadacitinib in patients with PsA and prior inadequate response or intolerance to at least one biologic disease-modifying antirheumatic drug (DMARD). METHODS: In this 24-week randomised, placebo-controlled, double-blind, phase 3 trial, 642 patients were randomised (2:2:1:1) to once per day upadacitinib 15 mg or 30 mg, placebo followed by upadacitinib 15 mg or placebo followed by upadacitinib 30 mg at week 24. The primary endpoint was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 12. Achievement of minimal disease activity (MDA) was assessed at week 24. Treatment-emergent adverse events are reported for all patients who received at least one dose of trial drug. RESULTS: At week 12, significantly more patients receiving upadacitinib 15 mg and 30 mg versus placebo achieved ACR20 (56.9% and 63.8% vs 24.1%; p<0.001 for both comparisons). At week 24, MDA was achieved by more upadacitinib 15 mg-treated (25.1%) and 30 mg-treated patients (28.9%) versus placebo (2.8%; p<0.001 for both comparisons). Generally, the rates of treatment-emergent adverse events were similar with placebo and upadacitinib 15 mg and higher with upadacitinib 30 mg at week 24. Rates of serious infections were 0.5%, 0.5% and 2.8% with placebo, upadacitinib 15 mg and upadacitinib 30 mg, respectively. CONCLUSION: In this trial of patients with active PsA who had inadequate response or intolerance to at least one biologic DMARD, upadacitinib 15 mg and 30 mg was more effective than placebo over 24 weeks in improving signs and symptoms of PsA. CLINICAL TRIAL REGISTRATION NUMBER: NCT03104374.

13.
J Rheumatol ; 2020 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-33191289

RESUMO

OBJECTIVE: Therapeutic response was evaluated among new apremilast, methotrexate, or biologic disease-modifying anti-rheumatic drug (bDMARD) initiators with oligoarticular psoriatic arthritis (PsA). METHODS: Patients with oligoarticular PsA in the Corrona PsA/Spondyloarthritis Registry initiating treatment with apremilast, methotrexate, or bDMARD and completing 6-month follow-up were included. RESULTS: In total, 150 patients initiated monotherapy (apremilast: n=34; methotrexate: n=15; bDMARD: n=101). Apremilast initiators had higher baseline disease activity than methotrexate initiators. At follow-up, apremilast initiators experienced numerically greater disease activity improvements than methotrexate initiators and similar improvements to bDMARD initiators. CONCLUSION: Findings suggest apremilast monotherapy is an effective option for patients with oligoarticular PsA.

14.
J Rheumatol ; 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33004532

RESUMO

OBJECTIVE: To compare disease characteristics, quality of life (QOL), and work productivity of patients with psoriatic arthritis (PsA) who had multidomain vs single-domain presentations. METHODS: Adults with PsA enrolled in the Corrona PsA/SpA Registry (March 2013-August 2018) were included. Six PsA disease domains were evaluated: enthesitis, dactylitis, peripheral arthritis (PA), nail psoriasis, axial disease, and skin disease. Patients were classified as having multidomain (≥ 2 domains) or single-domain disease presentations; biologic initiators were characterized separately. Linear regression models evaluated the association of multidomain presentations with disease characteristics, QOL, and work productivity vs single-domain presentations. RESULTS: Of 2617 patients with PsA, 1698 (64.9%) had multidomain presentations, 617 (23.6%) had single-domain presentations, and 302 (11.5%) had no active disease features. Of 354 biologic initiators, 289 (81.6%) had multidomain presentations, 45 (12.7%) had single-domain presentations, and 20 (5.6%) had no active disease features. Overall, the most common singledomain and multidomain presentations, respectively, were skin disease (12.7%) and PA + skin disease (11.7%). Multidomain presenters were more likely to have fibromyalgia, depression, anxiety, and prior biologic use than single-domain presenters. Multidomain presentations were associated with significantly worse patient and physician global assessments of disease activity, pain, and fatigue; Health Assessment Questionnaire Disability Index and EQ-5D scores; and work productivity at enrollment. CONCLUSION: In this US real-world cohort, most patients had multidomain disease presentations, which was associated with worse disease activity, QOL, and work productivity measures. This study highlights the heterogeneity of PsA and the importance of assessing all PsA domains for optimizing disease management.

15.
Arthritis Rheumatol ; 2020 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-33043600

RESUMO

OBJECTIVE: Guselkumab, a human monoclonal antibody specific to interleukin-23p19, demonstrated efficacy and safety versus placebo through Week24 of the Phase-3 DISCOVER-2 trial in biologic-naïve psoriatic arthritis (PsA) patients. Here we report 1-year DISCOVER-2 findings. METHODS: Adults with active PsA (≥5 swollen+≥5 tender joints; C-reactive protein ≥0.6mg/dL) despite standard nonbiologic treatment were randomized to receive subcutaneous injections of guselkumab 100mg every-4-weeks (Q4W); guselkumab 100mg at Week0, Week4, Q8W; or placebo with crossover to guselkumab 100mg Q4W at Week24. We primarily evaluated clinical efficacy through Week52 by imputing missing data (nonresponse for categorical endpoints; no change/using multiple imputation for continuous endpoints). Observed radiographic scores and adverse events (AEs) were summarized. RESULTS: Of 739 randomized, treated patients, 93% completed Week52. Proportions of patients achieving ≥20% improvement from baseline in ACR criteria (ACR20) were maintained post-Week24, reaching 71% (173/245) and 75% (185/248) for Q4W- and Q8W- randomized patients, respectively, by Week52. The proportions of patients achieving ACR50/ACR70 and skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution were also maintained through Week52. Further, low levels of radiographic progression, along with improvements in physical function and health-related quality-of-life, were sustained through Week52 with continued guselkumab. Few patients experienced serious infections through Week52, with no evidence of a dosing regimen response or increase from Week0-24 (4/493 [0.8%]) to Week24-52 (3/493 [0.6%]) among guselkumab-randomized patients. No patient developed an opportunistic infection or died. CONCLUSION: In biologic-naïve PsA patients, guselkumab provided sustained improvements across diverse manifestations and maintained a favorable benefit-risk profile through Week52.

16.
J Rheumatol ; 2020 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-33060307

RESUMO

OBJECTIVE: To examine the association of nail psoriasis with disease activity, quality of life, and work productivity in patients with psoriatic arthritis (PsA). METHODS: All patients with PsA who enrolled in the Corrona PsA/Spondyloarthritis Registry between March 2013 and October 2018 and had data on physician-reported nail psoriasis were included and stratified by presence vs absence of nail psoriasis at enrollment. Patient demographics, disease activity, quality of life, and work productivity at enrollment were compared between patients with vs without nail psoriasis using t-tests or Wilcoxon rank-sum tests for continuous variables and χ2 or Fisher exact tests for categorical variables. RESULTS: Of the 2841 patients with PsA included, 1152 (40.5%) had nail psoriasis and 1689 (59.5%) did not. Higher proportions of patients with nail psoriasis were male (51.9% vs 44.1%) and disabled from working (12.3% vs 7.8%) compared with patients without nail psoriasis (all P < 0.05). Patients with nail psoriasis had higher disease activity than those without nail psoriasis, including higher tender and swollen joint counts, worse Disease Activity in Psoriatic Arthritis and Psoriatic Arthritis Disease Activity Score values, and increased likelihood of having enthesitis and dactylitis (all P< 0.05). Patients with nail psoriasis had worse pain, fatigue, and work and activity impairment than those without nail psoriasis (all P < 0.05). CONCLUSION: Patients with PsA who have nail psoriasis had worse disease activity, quality of life, and work productivity than those without nail involvement, emphasizing the importance of identification and management of nail disease in patients with PsA.

17.
RMD Open ; 6(3)2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33115768

RESUMO

INTRODUCTION: Psoriatic arthritis (PsA) is a heterogeneous chronic inflammatory musculoskeletal disorder that manifests as peripheral arthritis, dactylitis, enthesitis and spondylitis. PsA results in significant burden that impacts quality of life of patients. We examined the signs, symptoms and impacts reported by patients with PsA, to characterise the patient experience of PsA and develop a conceptual model representing this patient experience. METHODS: Semi-structured interviews were conducted with patients with PsA recruited through the FORWARD databank. Spontaneous and probed signs, symptoms and impacts of PsA were assessed. Patients rated the disturbance of these concepts on their lives using a scale from 0 ('does not disturb') to 10 ('greatly disturbs'). Signs, symptoms and impacts reported by >80% of patients with a disturbance rating of ≥5 were defined as salient concepts. Recruitment continued until concept saturation was achieved. RESULTS: 19 patients with PsA were interviewed. The interviews elicited 42 symptoms of which 8 had not been identified in a previous literature review encompassing 15 relevant articles. The most salient signs and symptoms elicited in the interviews were joint pain, skin symptoms, stiffness, swollen/inflamed joints and fatigue all with moderate to high disturbance ratings (range: 5.5-7.8). The most salient impacts were sleep disturbance, physical disability, effects on daily activities and feelings of frustration with also moderate to high disturbance ratings (range: 6.1-7.4). CONCLUSIONS: The interviews highlighted the adverse impact PsA has on the patient's life and may inform on outcome variables or areas suitable to be assessed in PsA studies.

18.
Ann Rheum Dis ; 2020 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-33106286

RESUMO

OBJECTIVE: To compare the efficacy and safety of brodalumab, an interleukin-17 receptor subunit A inhibitor, with placebo, in patients with psoriatic arthritis (PsA). METHODS: Adult patients with active PsA and inadequate response to, or intolerance to, conventional treatment were enrolled into two phase III studies (NCT02029495 and NCT02024646) and randomised 1:1:1 to receive subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks. About 30% of patients had prior use of biologics. The primary endpoint for both studies was the American College of Rheumatology 20 (ACR20) response at week 16. RESULTS: 962 patients were randomised across the studies prior to early termination due to sponsor decision. The primary endpoint was met in both studies. Based on comparable design and eligibility criteria, data from both studies were pooled. Significantly more patients achieved ACR20 at week 16 in both brodalumab treatment groups (45.8% and 47.9% for 140 mg and 210 mg, respectively) versus placebo (20.9%) (p<0.0001). Similar results were observed at week 24. Significantly higher proportions of patients receiving brodalumab achieved ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis versus placebo (p<0.01). Adverse event rates were similar across treatments at week 16 (54.4%, 51.6% and 54.5% for placebo, brodalumab 140 mg and 210 mg, respectively). No new safety signals were reported. CONCLUSION: Brodalumab was associated with rapid and significant improvements in signs and symptoms of PsA versus placebo. Brodalumab was well tolerated, with a safety profile consistent with other interleukin-17 inhibitors.

19.
Artigo em Inglês | MEDLINE | ID: mdl-32937016

RESUMO

OBJECTIVES: To examine concurrent validity and discrimination of modified minimal disease activity (mMDA) criteria in peripheral spondyloarthritis (pSpA) following OMERACT filter principles and determine predictors of mMDA response. METHODS: Four mMDA versions were derived in the ABILITY-2 study using the SPondyloArthritis Research Consortium of Canada (SPARCC) or Leeds Enthesitis Index (LEI) but excluding psoriasis. To assess concurrent validity, mMDA versions were correlated with Peripheral SpondyloArthritis Response Criteria (PSpARC) remission, Ankylosing Spondylitis Disease Activity Score for inactive disease (ASDAS ID), and physician global. Treatment discrimination was assessed between adalimumab and placebo at week 12. Multiple logistic regression was used to determine baseline predictors of long-term mMDA responses and sustained mMDA. RESULTS: The four mMDA versions showed a stronger positive correlation with PSpARC remission (rtet >0.95) versus ASDAS ID (rtet >0.75) at week 12 and years 1-3 and were able to show discrimination (p<0.001). Responsiveness was shown at week 12; significantly more patients receiving adalimumab versus placebo achieved all four versions of mMDA. Approximately 40-60% of adalimumab-treated patients achieved mMDA-LEI or SPARCC at years 1-3. Achieving mMDA response after 12 weeks of adalimumab treatment was a robust positive predictor of attaining long-term mMDA through 3 years (odds ratios: 11.38-27.13 for mMDA-LEI; 17.98-37.85 for mMDA-SPARCC). CONCLUSIONS: All four versions of mMDA showed concurrent validity and discriminated well between adalimumab and placebo treatment groups. Early mMDA response is a more consistent predictor of long-term mMDA achievement than baseline characteristics. The 5 of 6 versions of mMDA could be an appropriate treatment target in pSpA patients.

20.
Artigo em Inglês | MEDLINE | ID: mdl-32864685

RESUMO

OBJECTIVES: To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA. METHODS: The trial randomised 851 patients to receive weekly: MTX (20 mg/week), etanercept (50 mg/week) or MTX plus etanercept. Dichotomous composite measures examined included ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA). Continuous composite measures examined included Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS). RESULTS: At week 24, etanercept-treated groups were significantly more effective than MTX monotherapy to achieve ACR 20 (primary end point) and MDA (key secondary end point). When examining score changes from baseline at week 24 across the five continuous composite measures, PASDAS demonstrated relatively greater changes in the etanercept-treated groups compared with MTX monotherapy and had the largest effect size and standardized response. Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments. CONCLUSION: PASDAS was the most sensitive continuous composite measure examined with results that mirrored the protocol-defined primary and key secondary outcomes. Composite measures with multiple domains, such as PASDAS, may better quantify change in PsA disease burden. TRAIL REGISTRATION: https://ClinicalTrials.gov, number NCT02376790.

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