Measurement of minimal disease activity in psoriatic arthritis using PROMIS‐Physical Function or the Health Assessment Questionnaire‐Disability Index

2020 ◽  
Author(s):  
Erin Chew ◽  
Jamie Perin ◽  
Thomas Grader‐Beck ◽  
Ana‐Maria Orbai
2021 ◽  
pp. jrheum.200927
Author(s):  
Weiyu Ye ◽  
Simon Hackett ◽  
Claire Vandevelde ◽  
Sarah Twigg ◽  
Philip S. Helliwell ◽  
...  

Objective To compare physical function scales of the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) to the Health Assessment Questionnaire Disability Index (HAQDI) in patients with psoriatic arthritis (PsA), and examine whether either questionnaire is less prone to ‘floor effects’. Methods Data were collected prospectively from 2018 to 2019 across three UK hospitals. All patients completed physical function scales within the MDHAQ and HAQDI in a single clinic visit. Agreement was assessed using medians and the Bland-Altman method. Intraclass correlation coefficients (ICCs) were used to assess test-retest reliability. Results 210 patients completed the clinic visit; one withdrew consent thus 209 were analysed. 60.0% were male, with mean age of 51.7 years and median disease duration of 7 years. In clinic, median MDHAQ and HAQDI including/excluding aids scores were 0.30, 0.50 and 0.50 respectively. Although the median score for HAQDI is higher than MDHAQ, the difference between the two mostly lies within 1.96 standard deviations from the mean suggesting good agreement. The ICCs demonstrated excellent test-retest reliability for both HAQ questionnaires.Similar numbers of patients scored ‘0’ on the MDHAQ and HAQDI including/excluding aids (48, 47, and 49 respectively). Using a score of ≤0.5 as a cut-off for minor functional impairment, 23 patients had a MDHAQ ≤0.5 when their HAQDI including aids >0.5. Conversely, 4 patients had a MDHAQ > 0.5 when the HAQDI including aids ≤0.5. ConclusionBoth HAQ questionnaires appear to be similar in detecting floor effects in patients with PsA.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 998.2-998
Author(s):  
S. Unizony ◽  
J. Dang ◽  
J. Han ◽  
M. Michalska ◽  
J. H. Best

Background:The efficacy and safety of intravenous (IV) and subcutaneous (SC) tocilizumab (TCZ) in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and as monotherapy in patients with rheumatoid arthritis (RA) has been demonstrated in large clinical trials and real-world data studies. The Health Assessment Questionnaire Disability Index (HAQ-DI) is commonly used to assess physical function in patients with RA. While HAQ-DI outcomes at Week 24 in TCZ clinical trials have been reported, outcomes at Week 12 and results stratified by treatment response categories at Weeks 12 and 24 have not been previously described.Objectives:To report the association between change in HAQ-DI from baseline to Weeks 12 and 24 and Disease Activity Score in 28 joints (DAS28) response categories in patients who received TCZ or comparators in TCZ clinical trials.Methods:Data from patients with active RA who received TCZ or a comparator from 6 Phase III or IV TCZ-IV studies (OPTION [NCT00106548], RADIATE [NCT00106522], TOWARD [NCT00106574] LITHE [NCT00109408], ACT-RAY [NCT00810199] and ADACTA [NCT01119859]) and 1 Phase III TCZ-SC study (BREVACTA [NCT01232569]) were analyzed. Mean change in HAQ-DI score at Weeks 12 and 24 was assessed in patients stratified by DAS28 disease activity level (DAS28 < 2.6 [remission], DAS28 ≥ 2.6 to ≤ 3.2 [low disease activity; LDA], DAS28 > 3.2 to ≤ 5.1 [moderate disease activity; MDA], DAS28 > 5.1 [high disease activity; HDA] at Weeks 12 and 24. The adjusted least squares mean (LSM) change from baseline was estimated using a mixed model with repeated measures, including region (North America vs non-North America), RA duration (> 2 years vs ≤ 2 years), baseline HAQ-DI and DAS28, treatment, visit, visit by treatment and visit by baseline HAQ-DI.Results:Data from 5051 patients were included. Across all studies, the mean duration of RA ranged from 6.3 to 12.6 years. At baseline, patients had severe RA with a mean DAS28 ≥ 6.3; baseline HAQ-DI was ≥ 1.5. At Week 12, patients who achieved remission or LDA had greater improvements in HAQ-DI than those in MDA or HDA (Figure 1). Results were similar at Week 24 (Figure 2). Among patients who received TCZ and achieved remission or LDA, mean improvement in HAQ-DI was ≥ 0.65 and ≥ 0.44, respectively, at Week 12 (Figure 1) and ≥ 0.48 and ≥ 0.43 at Week 24 (Figure 2). Mean changes in HAQ-DI were similar between patients who received TCZ-IV in combination with MTX or as monotherapy (ACT-RAY) and in those who received TCZ-IV or ADA as monotherapy (ADACTA).Conclusion:Patients with long-standing, severe RA who received IV or SC TCZ as monotherapy or in combination with csDMARDs had improvement in physical function and disease activity at Week 12 that was maintained at Week 24. Overall, across all the trials, response to treatment was associated with improvement in physical function.Acknowledgments :This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests: :Sebastian Unizony Grant/research support from: Genentech, Inc., Joseph Dang Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Margaret Michalska Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Jennie H. Best Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Maria Chiara Ditto ◽  
Simone Parisi ◽  
Marta Priora ◽  
Silvia Sanna ◽  
Clara Lisa Peroni ◽  
...  

Abstract AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.


2015 ◽  
Vol 43 (2) ◽  
pp. 350-355 ◽  
Author(s):  
Fabio Massimo Perrotta ◽  
Antonio Marchesoni ◽  
Ennio Lubrano

Objective.A state of remission is the target of therapy in chronic arthritis. The aim of the present study was to assess the rate of minimal disease activity (MDA) and remission in patients with psoriatic arthritis (PsA) treated with tumor necrosis factor (TNF-α) blockers. Disease characteristics and predictors of MDA were also evaluated.Methods.Patients fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria and treated with TNF-α blockers adalimumab, etanercept, or golimumab were enrolled and prospectively followed every 4 months for 1 year in a clinical practice setting. Patients were considered in MDA when they met at least 5/7 of the criteria previously defined. Other remission criteria evaluated were 28-joint Disease Activity Score-C-reactive protein (DAS28-CRP) < 2.6 and Disease Activity in Psoriatic Arthritis (DAPSA) score ≤ 3.3. Patients achieving MDA were compared to non-MDA to identify outcome predictor factors.Results.Of the 75 patients treated with TNF-α blockers, at baseline no patients were in MDA or had a DAPSA score ≤ 3.3, while 25 (21.3%) had a DAS28-CRP score < 2.6. Five patients (6%) discontinued treatment because of side effects or inefficacy during followup. After 12 months, MDA was achieved in 46 patients (61.3%). No difference was found among the 3 anti-TNF-α drugs. Predictors for MDA were found to be male sex, high CRP, high erythrocyte sedimentation rate, and low Health Assessment Questionnaire.Conclusion.In our prospective observational study, based on a clinical practice setting, MDA was achieved in 61.3% of patients treated with TNF-α blockers, identifying this as an achievable target for patients with PsA. Predictors of remission were also identified.


2013 ◽  
Vol 40 (5) ◽  
pp. 647-652 ◽  
Author(s):  
Philip J. Mease ◽  
Michele Heckaman ◽  
Sonja Kary ◽  
Hartmut Kupper

Objective.This posthoc analysis evaluated the percentage of patients with psoriatic arthritis (PsA) who achieved minimal disease activity (MDA) and compared the results with a modified MDA substituting the physician global assessment (PGA) for the Psoriasis Activity and Severity Index (PASI) using data from the ADalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT; NCT00646386).Methods.Patients with active PsA were randomized to receive adalimumab 40 mg or placebo every other week for 24 weeks. MDA was defined as achieving ≥ 5 of the following criteria: tender joint count ≤ 1; swollen joint count ≤ 1; PASI ≤ 1 or body surface area ≤ 3%; patient pain score ≤ 15 [1–100 mm visual analog scale (VAS)]; patient global assessment (PGA) of disease activity ≤ 20 (1–100 mm VAS); Health Assessment Questionnaire ≤ 0.5; and tender entheseal points ≤ 1 (only heels assessed). For modification of the MDA, PASI ≤ 1 was substituted with PGA “Clear” as MDAPGA1 and PGA “Clear” or “Almost clear” as MDAPGA2.Results.Sixty-seven patients were treated with adalimumab and 69 with placebo. At Week 24, MDA, MDAPGA1, and MDAPGA2 were achieved by 39%, 37%, and 39%, respectively, of patients treated with adalimumab versus 7%, 5%, and 8% of patients on placebo (p < 0.001). Kappa coefficients indicated good agreement between PASI and PGA at Week 24.Conclusion.ADEPT results indicated that significantly more patients treated with adalimumab achieved MDA by Week 24 compared with placebo. Modification of the MDA by replacing PASI ≤ 1 with PGA assessments did not alter the results, which may improve feasibility of practical use of the index.


Author(s):  
Rosana Quintana ◽  
Vicente Juárez ◽  
Adriana Silvestre ◽  
Mariana Aciar ◽  
Romina Nieto ◽  
...  

La artritis reumatoide (AR) es una patología crónica que genera limitación funcional, impactando en la calidad de vida de los pacientes y de su entorno familiar. El objetivo de este estudio fue estimar la prevalencia de AR en las comunidades de pueblos originarios qom y wichi de la ciudad de Rosario y Misión Chaqueña (Salta); además de comparar las características entre ambas. Se realizó un estudio transversal, epidemiológico, de base comunitaria, utilizando la metodología Community Oriented Program for the Control of Rheumatic Diseases (COPCORD). Los individuos con dolor músculo—esquelético (casos positivos) fueron evaluados en forma consecutiva por médicos generales y referenciados dentro de la semana al reumatólogo para diagnóstico y eventual tratamiento. La prevalencia de AR fue de 3% (qom) y 3.2% (wichi). Las características de la AR fueron similares en ambas comunidades en relación a la actividad medida por Disease Activity Score—28 (DAS 28) (p 0,341) pero no en la limitación funcional medida por Health Assessment Questionnaire Disability Index (HAQ) (p 0,031). Existió un retraso promedio en el diagnóstico de 2 años. El 45% y 66% (p 0,100) de los pacientes qom y wichi tuvieron cambios radiográficos propios de una enfermedad avanzada. Más del 90% fueron seropositivos para factor reumatoideo y anticuerpos antipéptido citrulinado cíclico. El 42% y 29% (p 0,246) de los pacientes qom y wichi tenían antecedentes familiares de AR. Las prevalencias de AR en ambas comunidades fueron altas, con marcada agresividad de la enfermedad, así como impactante limitación funcional. El retraso en el diagnóstico es un factor fundamental para mejorar el pronóstico de esta patología.


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