scholarly journals FRI0599 USEFUL II: DERIVATION OF THE LUPUS ARTHRITIS AND MUSCULOSKELETAL DISEASE ACTIVITY SCORE (LAMDA) USING DATA FROM A MULTICENTRE LONGITUDINAL STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 905.2-906
Author(s):  
K. Mahmoud ◽  
A. Zayat ◽  
M. Y. MD Yusof ◽  
C. Ciurtin ◽  
C. S. Yee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Disease Activity ◽  
Effect Size ◽  
Lasso Regression ◽  
Minimal Disease Activity ◽  
Research Support ◽  
Becton Dickinson ◽  
Tender Joint ◽  
Patient Reported ◽  
Minimal Disease

Background:Musculoskeletal (MSK) disease is the commonest manifestation of SLE. We showed that the MSK components of the BILAG index and SLEDAI have limited sensitivity, specificity and responsiveness compared to ultrasound (US) synovitis. The USEFUL study evaluated response to glucocorticoids in SLE patients with inflammatory pain.Objectives:To develop a disease activity tool for lupus MSK manifestations that is continuous, responsive, sensitive, and correlates with US-synovitisMethods:133 patients who received depomedrone 120mg IM were assessed at 0, 2 and 6 weeks for 66/68 swollen and tender joint counts, BILAG2004 index, SLEDAI-2K, physician global and MSK-VAS, inflammatory markers, patient pain and disease activity-VAS. Total US score (OMERACT-EULAR) in the hands and wrists was calculated blinded to patient and clinical assessor. Patients reported overall response using a Likert scale.The LAMDA was developed by modelling a core set of clinical variables against total US score using penalized (Lasso) regression. Responsiveness was compared between LAMDA and other variables at week 6 using effect sizes. Minimum clinically important difference (MCID) was explored using the SEM and minimal disease activity threshold using ROC.Results:The variables selected for the LAMDA score were swollen joint count, patient MSK pain VAS, physician MSK disease activity VAS and ESR. A continuous score was derived. This had a theoretical range from 0 to 26.5 based on maximum ESR of 100. The highest value observed in USEFUL was 15. LAMDA was significantly higher in patients with active US (mean (SD) 5.71 (2.67), n=78) compared to patients with normal US (3.27 (1.77), n=55; difference (95% CI) -2.45 (-3.26, -1.63), t=-5.93, p<0.001). This difference remained significant in patients with no swollen joints (difference (95% CI) -0.71 (-1.40, -0.02), t=-2.06, p=0.044).Effect size was greater for the LAMDA (0.37) than the BILAG-MSK (0.31), SLEDAI-MSK (0.27) and total US score (0.33). In patients with active US at baseline, LAMDA’s effect size was 0.42.The MCID was 0.71 and correlated with patient-reported change in pain. A threshold for minimal disease activity of 3.23 optimized sensitivity (0.77 (0.65, 0.89)) and specificity (0.80 (0.68, 0.92)) against US score >0.Conclusion:The LAMDA score is a novel continuous disease activity instrument for MSK manifestations of SLE derived from variables familiar to rheumatologists. The LAMDA score is sensitive to imaging detected synovitis without swelling and more responsive than other instruments. . LAMDA may improve the ability of clinicians to accurately determine therapeutic efficacy in clinical trials and practice. Future work will validate the LAMDA score in independent cohorts and randomized trials.Acknowledgements:This project was funded by Lupus UKDisclosure of Interests:Khaled Mahmoud: None declared, Ahmed Zayat: None declared, Md Yuzaiful Md Yusof: None declared, Coziana Ciurtin Grant/research support from: Pfizer, Consultant of: Roche, Modern Biosciences, Chee-Seng Yee: None declared, David Isenberg Consultant of: Study Investigator and Consultant to Genentech, Lee-Suan Teh: None declared, Katherine Dutton: None declared, David d’cruz Grant/research support from: GlaxoSmithKline, Nora Ng: None declared, Philip G Conaghan Consultant of: AbbVie, BMS, Eli Lilly, EMD Serono, Flexion Therapeutics, Galapagos, GSK, Novartis, Pfizer, Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Christopher Edwards Grant/research support from: Abbvie, Biogen, Roche, Consultant of: Abbvie, Samsung, Speakers bureau: Abbvie, BMS, Biogen, Celgene, Fresenius, Gilead, Janssen, Lilly, Mundipharma, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, UCB, Elizabeth Hensor: None declared, Edward Vital Grant/research support from: AstraZeneca, Roche/Genentech, and Sandoz, Consultant of: AstraZeneca, GSK, Roche/Genentech, and Sandoz, Speakers bureau: Becton Dickinson and GSK

FRI0277 EFFECTIVENESS OF BDMARDS IN AS AND NR-AXSPA PATIENT POPULATIONS: EXPERIENCE FROM THE CORRONA REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 725.1-726
Author(s):  
T. Hunter ◽  
T. Blachley ◽  
W. Malatestinic ◽  
L. Harrold ◽  
B. Dube ◽  
...  
Keyword(s):  
Disease Activity ◽  
Patient Characteristics ◽  
Response Rates ◽  
Tender Joint Count ◽  
Research Support ◽  
Tender Joint ◽  
Clinical Registry ◽  
Modest Improvement ◽  
Asas Criteria ◽  
Patient Reported

Background:Axial spondyloarthritis (axSpA) consists of ankylosing spondylitis (AS), also referred to as radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA). AxSpA can lead to reduced mobility, pain, fatigue, and impact quality of life. While bDMARDs are available for treatment, the literature lacks studies exploring their real-world effectiveness in clinical registry patients with axSpA.Table 1.Demographic characteristics and clinical response rates of AxSpA patientsTable 2.TNFi drug survival rate results of early and late disease courseObjectives:To describe patient characteristics of bDMARD initiators among the AS and nr-axSpA populations and the effectiveness of bDMARDs at the 6-month (± 3) post-initiation follow-up (FU) visit in the Corrona PsA/SpA Registry.Methods:This study included patients aged ≥ 18 years with AS per modified NY criteria and nr-axSpA per ASAS criteria enrolled between 3/2013 and 9/2019. Concurrently diagnosed patients with PsA were excluded. Baseline characteristics, such as demographic, clinical, disease activity, treatment, and patient-reported outcomes (PRO), were collected for those initiating a bDMARD at enrollment or during FU; response rates and mean change in disease activity and PRO between initiation and 6-month FU were calculated.Results:The AS (n=179) and nr-axSpA (n=32) bDMARD initiators groups were similar at initiation for mean age (AS: 49.1 yrs, nr-axSpA: 48.9 yrs), ASDAS scores (AS: 2.9, nr-axSpA: 2.8) and patient global assessment (AS: 59.6, nr-axSpA: 60.0). The two groups were different for time from disease duration (AS 8.5 yrs, nr-axSpA, 6.6 yrs), current NSAID use (AS: 64.2%, nr-axSpA: 46.9%) and naivete to cDMARDS (AS: 70.4%, nr-axSpA: 40.6%), TNFs (AS: 47.5%, nr-axSpA: 21.9%), non-TNFs (AS: 96.1%, nr-axSpA: 93.8%) and bDMARDs (AS: 46.9%, nr-axSpA: 21.9%). Patients were similarly impacted by their condition for BASDAI (AS: 5.0, nr-axSpA, 5.6), pain (AS: 55.8, nr-axSpA, 60.8) and fatigue (AS: 51.6, nr-axSpA, 59.9), but there was an imbalance in tender joint count (AS: 2.6, nr-axSpA, 13.4).At 6-month FU, both populations experienced minimal or no change in ASDAS scores (AS: -0.3, nr-axSpA: 0.0) remaining in a high state of disease activity (ASDAS, ≥2.2). A small percent of both groups achieved ASAS20 (AS: 20.1%; nr-axSpA: 21.9%) and ASAS40 (AS: 14 %, nr-axSpA: 15.6%). Further, bDMARD initiators had minimal decreases in BASDAI (AS: -0.6, nr-axSpA: -0.8), pain (AS: -8.5, nr-axSpA: -12.2), and fatigue (AS: -5.0, nr-axSpA: -7.9) scores.Conclusion:AS and nr-axSpA bDMARD initiators had a modest improvement in outcomes at six months. Twenty percent or fewer patients achieved ASAS20 or ASAS40, with many having residual impairment based on ASDAS, BASDAI, pain, and fatigue outcomes at six months. While patients are initiating biologic agents, room for improvement exists as many are not achieving optimal treatment response of inactive (ASDAS, <1.3) or low disease activity (ASDAS, <2.1).Disclosure of Interests:Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Taylor Blachley Employee of: Corrona, LLC, William Malatestinic Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Leslie Harrold Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Consultant of: AbbVie, BMS, Roche – consultant, Employee of: Corrona, LLC – employment, Blessing Dube Employee of: Corrona, LLC, Meghan Glynn Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Employee of: Corrona, LLC – employment, Jeffrey Lisse Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau

scholarly journals Prevalence of Psoriatic Arthritis Patients Achieving Minimal Disease Activity in Real-world Studies and Randomized Clinical Trials: Systematic Review with Metaanalysis

2019 ◽  
Vol 47 (6) ◽  
pp. 839-846
Author(s):  
Mariele Zardin-Moraes ◽  
André Luis Ferreira Azeredo da Silva ◽  
Carla Saldanha ◽  
Charles Lubianca Kohem ◽  
Laura C. Coates ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Cochrane Library ◽  
Minimal Disease Activity ◽  
Cross Sectional ◽  
Minimal Disease

Objective.To estimate the frequency of patients with psoriatic arthritis (PsA) achieving minimal disease activity (MDA) status in real-world studies and randomized controlled trials (RCT).Methods.A systematic literature search for 2009–2017 was performed in PubMed, Embase, Cochrane Library, and LILACS. Study selection and data extraction were performed by 2 independent researchers. Random-effects single-arm metaanalyses were performed and heterogeneity was assessed using I2.Results.A total of 405 records were identified and 45 studies were analyzed: 39 (86.7%) observational studies and 6 (13.3%) RCT; they included 12,469 patients. The overall prevalence of MDA in cross-sectional studies was 35% (95% CI 30%–41%, I2 = 94%), varying from 17% (95% CI 7%–34%) in patients taking synthetic disease-modifying antirheumatic drugs (DMARD) to 57% (95% CI 41%–71%) in those taking biological DMARD. Prevalence of MDA in cohort studies increased with longer followup time, ranging from 25% (95% CI 15%–40%) with 3- to 4-month followup to 42% (95% CI 38%–45%) with > 24-month followup. Patients with PsA receiving biological DMARD in a real-world context and RCT had similar prevalence of MDA at 6-month followup: 30% (95% CI 21%–41%, I2 = 85%) versus 32% (95% CI 26%–39%, I2 = 79%), respectively.Conclusion.Patients with PsA included in real-world studies had similar prevalence of MDA compared to those in controlled clinical trials. This finding suggests that MDA is a useful treatment target for PsA in the real-world setting.

scholarly journals Real-world validation of the minimal disease activity index in psoriatic arthritis: an analysis from a prospective, observational, biological treatment registry

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016619 ◽  
Author(s):  
Proton Rahman ◽  
Michel Zummer ◽  
Louis Bessette ◽  
Philip Baer ◽  
Boulos Haraoui ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Clinical Care ◽  
Secondary Outcome ◽  
Tender Joint Count ◽  
Minimal Disease Activity ◽  
Lower Baseline ◽  
Patient Reported ◽  
Minimal Disease

ObjectiveTo describe the minimal disease activity (MDA) rate over time in patients with psoriatic arthritis (PsA) receiving antitumour necrosis factor agents, evaluate prognostic factors of MDA achievement and identify the most common unmet criteria among MDA achievers.DesignBiologic Treatment Registry Across Canada (BioTRAC): ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis or PsA with infliximab (IFX), golimumab (GLM) or ustekinumab.Setting46 primary-care Canadian rheumatology practices.Participants223 patients with PsA receiving IFX (enrolled since 2005) and GLM (enrolled since 2010) with available MDA information at baseline, 6 months and/or 12 months.Primary and secondary outcome measuresMDA was defined as ≥5 of the following criteria: 28-item tender joint count (TJC28) ≤1, 28-item swollen joint count (SJC28) ≤1, Psoriasis Area and Severity Index (PASI) ≤1 or body surface area≤3, Pain Visual Analogue Scale (VAS) ≤15 mm, patient’s global assessment (PtGA) (VAS) ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, tender entheseal points ≤1. Independent prognostic factors of MDA achievement were assessed with multivariate logistic regression.ResultsMDA was achieved by 11.7% of patients at baseline, 43.5% at 6 months, 44.8% at 12 months and 48.8% at either 6 or 12 months. Among MDA achievers at 6 months, 75.7% had sustained MDA at 12 months. Lower baseline HAQ (OR=0.210; 95% CI: 0.099 to 0.447) and lower TJC28 (OR=0.880; 95% CI: 0.804 to 0.964), were significant prognostic factors of MDA achievement over 12 months of treatment. The most commonly unmet MDA criteria among MDA achievers was patient reported pain (25%), PtGA (15%) and PASI (12%).ConclusionsAlmost 50% of patients treated with IFX or GLM in routine clinical care achieved MDA within the first year of treatment. Lower baseline HAQ and lower TJC28, were identified as significant prognostic factors of MDA achievement. The most commonly unmet criteria in patients who achieved MDA were pain, PtGA and PASI.Trial registration numberBioTRAC (NCT00741793).

scholarly journals P261 Continuing versus withdrawing ixekizumab in patients with PsA who achieved sustained minimal disease activity: results from the SPIRIT-P3 study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Laura C Coates ◽  
Sreekumar G Pillai ◽  
Lu Zhang ◽  
David Adams ◽  
Lisa Kerr ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Treatment Period ◽  
Median Time ◽  
Safety Data ◽  
Geographic Region ◽  
Minimal Disease Activity ◽  
Research Support ◽  
Minimal Disease ◽  
Time To Relapse

Abstract Background This study evaluated efficacy and safety of continuing vs. withdrawing ixekizumab (IXE), an IL-17A antagonist, in psoriatic arthritis (PsA) patients who achieved sustained minimal disease activity (MDA) on IXE and re-treating with IXE if required. Methods SPIRIT-P3 (NCT02584855) was a multicentre phase 3b study enrolling biologic-naïve patients with active PsA (diagnosis for ≥6 months, meeting classification criteria for psoriatic arthritis, ≥3/68 tender joints, ≥3/66 swollen joints) and previous inadequate response to conventional synthetic DMARDs (csDMARDs). Patients entered a 36-week, open-label (OL) treatment period with IXE every 2 weeks. Between Weeks 36-64, patients were randomised 1:1 to IXE or placebo (PBO) at the visit for which randomisation criteria were met (sustained MDA for at least 4 visits over 3 consecutive months) and evaluated up to Week 104. Patients not meeting randomisation criteria by Week 64 continued IXE up to Week 104. Maintenance of treatment response was measured by time to loss of sustained MDA (relapse) during randomised withdrawal (RW) period. The proportion of patients who relapsed during the first 40 weeks of RW period and time to regain MDA after re-treatment with IXE in relapsed patients were assessed. The Kaplan-Meier product limit method was used to estimate survival curves for time-to variables. Treatment comparisons were performed using a log-rank test adjusting for geographic region and csDMARD use as factors. Cumulative proportion of relapse was analysed using a logistic regression model with treatment, geographic region, and csDMARD use as factors. Safety data were summarised for the entire study period for patients who received ≥1 dose of IXE. Results In total, 394 patients entered the OL treatment period; 158 (40%) achieved sustained MDA criteria and were randomised to IXE (N = 79) or PBO (N = 79). Baseline characteristics were similar between groups. Time to relapse on PBO was significantly shorter than for IXE (p &lt; 0.001) during RW period, with a median time to relapse of 22.3 weeks in the PBO group. The cumulative relapse rate during the first 40 weeks of RW period was 73% for PBO vs. 34% for IXE (p &lt; 0.001). Of those who relapsed on PBO, 96% regained MDA following re-treatment with IXE. The median time to regain MDA was 4.1 weeks (95%CI 4.14-4.29) for PBO and 4.7 weeks (95%CI 4.14-8.29) for IXE. Safety data were consistent with previous IXE PsA studies with no unexpected safety signals. Conclusion Continued IXE therapy was superior to PBO in maintaining MDA in biologic-naïve PsA pts who achieved sustained MDA on initial IXE treatment. A vast majority of patients who lost MDA after IXE withdrawal regained MDA with IXE re-treatment. Continuous IXE treatment is optimal for maintaining MDA; however, patients can regain MDA after re-treatment with IXE in case of treatment interruption. Disclosures L.C. Coates: Corporate appointments; L. Coates is a consultant for: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, and UCB. Consultancies: L. Coates is a consultant for: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, and UCB. S.G. Pillai: Corporate appointments; S.G.P. is an employee and shareholder of Eli Lilly and Company. L. Zhang: Corporate appointments; Employee and shareholder of Eli Lilly and Company. D. Adams: Corporate appointments; Employee and shareholder of Eli Lilly and Company. L. Kerr: Corporate appointments; Employee and shareholder of Eli Lilly and Company. M. Hojnik: Corporate appointments; Employee and shareholder of Eli Lilly and Company. G. Gallo: Corporate appointments; Employee and shareholder of Eli Lilly and Company. I. Valter: None. H. Tahir: Grants/research support; H. Tahir has received grants/research support from: AbbVie, Celgene, Eli Lilly and Company, Janssen, and Novartis. V. Chandran: Grants/research support; V. Chandran has received grant/research support from AbbVie, is a consultant for: AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB. P. Mease: Consultancies; P. J. Mease is a consultant for and has received grant/research support from: AbbVie, Amgen, BMS, Celgene, Crescendo, Eli Lilly and Company, Genentech, Janssen, Merck, Novartis, Pfizer, UCB, is on the. A. Kavanaugh: Consultancies; A. Kavanaugh is a consultant for Eli Lilly and Company.

scholarly journals Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT

2013 ◽  
Vol 40 (5) ◽  
pp. 647-652 ◽  
Author(s):  
Philip J. Mease ◽  
Michele Heckaman ◽  
Sonja Kary ◽  
Hartmut Kupper
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Health Assessment ◽  
Severity Index ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Minimal Disease Activity ◽  
Tender Joint ◽  
Minimal Disease

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.

scholarly journals AB0823 MINIMAL DISEASE ACTIVITY IN PSORIATIC ARTHRITIS IS ASSOCIATED WITH LOW IMPACT OF DISEASE ON PSAID12 QUESTIONAIRE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1715.2-1715
Author(s):  
J. A. Mosquera Martínez ◽  
C. García-Porrúa ◽  
L. Fernández-Dominguez ◽  
J. L. Guerra-Vazquez ◽  
J. Pinto-Tasende
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Rating Scale ◽  
Univariate Analysis ◽  
Minimal Disease Activity ◽  
Patient Reported ◽  
Minimal Disease ◽  
Clinical Records

Background:Psoriatic arthritis (PsA) has a prevalence of 0.58% in Spain and patients suffer this disease have significant impact on daily life due to articular, dermatological and psychological symptoms. To reach minimal disease activity (MDA) is a therapeutic goal recommended by EULAR for clinical practice.Objectives:Our aim was to assess the relationship between MDA and PsAID questionnaire in routine clinical practice.Methods:We performed a cross-sectional study of patient and physician reported outcomes. We obtained clinical information of patients with PsA attending clinic from October 2018 to October 2019. Data were collected from clinical records concerning age, gender, disease duration, joint counts, dactylitis, enthesitis, body surface area (BSA) of psoriasis, laboratory results (ESR and CRP), HAQ, PsAID12, pain and global assessment from patient with numerical rating scale (NRS) and MDA status. Data were analysed using SPSS21. Logistic regression was used to assess patient reported outcomes which were associated with achieving MDA.Results:Data were available for 210 patient visits, 57% males. MDA 5/7 was reached in 118 patients (56.2%) and MDA7/7 in 58 (27.6%). Age and gender were not associated with reach MDA. Higher disease duration was associated with MDA, OR 1.062 (1.012-1.114, 95% CI), p 0.015.PsAID12 was evaluated in 156 patients and all components were associated with reach MDA. Patients in MDA had significantly lower PsAID12 than those were not in MDA (mean 1.5 ± SD 1.5 vs. 3.8 ± 2.1), p< 0.0001. PsAID12 of less than 4 is considered a good outcome and individual components of PsAID12 (Figure 1, mean values for NRS) were less than 4 in patients with MDA.Figure 1.All components of PsAID12 were associated with MDA on univariate analysis but only pain and functional capacity remained independent predictors on multiple regression analysis (p< 0.0001 and p0.008 respectively).Percentage of BSA was associated with skin component of PsAID12 (p<0.0001) and with shame component (p0.001).Conclusion:In these PsA patients, MDA was reached mainly in patients with higher disease duration. MDA is a relevant treatment target in PsA, with markedly lower PsAID12 in patients in MDA. Pain and functional discapacity are dominant symptoms in patients with psoriatic arthritis, even in those in MDA. Skin affection is associated with skin and shame components on the PsAID12.References:[1]Queiro R et al. Arthritis Res Ther. 2017 Mar 29;19(1):72.Acknowledgments:SOGAREDisclosure of Interests:José Antonio Mosquera Martínez: None declared, Carlos García-Porrúa: None declared, Luis Fernández-Dominguez: None declared, Jose L. Guerra-Vazquez: None declared, Jose Pinto-Tasende Consultant of: Janssen, Novartis, Speakers bureau: Lilly, Janssen, Novartis, BMS, Pfizer, Celgene

scholarly journals OP0179 USEFUL STUDY I: A MULTICENTRE LONGITUDINAL STUDY TO TEST WHETHER ULTRASOUND CAN IDENTIFY PATIENTS WITH MUSCULOSKELETAL SYMPTOMS OF LUPUS WITH BETTER RESPONSE TO THERAPY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 111-112
Author(s):  
K. Mahmoud ◽  
A. Zayat ◽  
M. Y. MD Yusof ◽  
K. Dutton ◽  
L. S. Teh ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Clinical Trials ◽  
Clinical Response ◽  
Response To Therapy ◽  
Sensitivity Analyses ◽  
Musculoskeletal Symptoms ◽  
Research Support ◽  
Becton Dickinson ◽  
Tender Joint ◽  
Adjusted Sensitivity

Background:In SLE, musculoskeletal manifestations impact on quality of life and trial outcomes. We previously showed that assessments based on joint swelling lack sensitivity, specificity and responsiveness compared to ultrasound (US).Objectives:To determine clinical features predicting US synovitis and whether patients with US synovitis respond better to therapyMethods:SLE patients were recruited if the referring physician deemed they had inflammatory pain warranting treatment. Swollen joints were not required. At baseline, physicians recorded features of inflammation, concurrent fibromyalgia and osteoarthritis. Stable doses of prednisolone (≤5mg/day), antimalarials or immunosuppressants were allowed. Participants received depomedrone 120mg IM then were assessed at 0, 2 and 6 weeks for 66/68 swollen and tender joint counts, BILAG-2004, SLEDAI-2K, physician global and MSK-VAS, inflammatory markers, patient pain and disease activity-VAS, HAQ-DI, LupusQoL, US of hands and wrists (blinded to patient and clinical assessor). An internal pilot determined the primary endpoint:(Early Morning stiffness-VAS (EMS-VAS) at 2 weeks (adjusted for baseline) between patients with US-synovitis (GS≥2 or PD≥1 in ≥1 joint) vs. normal US at baseline. 20% difference was considered clinically meaningful. Sensitivity analyses adjusted for prednisolone and immunosuppressants.Results:122/133 patients completed all visits. There was significant disagreement between clinical examination and US. 78/133 had US synovitis; 68% of these had ≥1 swollen joint. Of 66/133 patients with ≥ 1 swollen joint, 20% had normal US. US-synovitis was more likely with joint swelling, a symmetrical small joint distribution and active serology. Physician-determined EMS, other lupus features or prior response to therapy were not associated. Fibromyalgia or osteoarthritis did not reduce the probability of US synovitis.In the full analysis set (n=133) there was no difference in EMS VAS at 2 weeks according to US synovial status at baseline (difference -8mm, 95% CI -19, 4mm, p=0.178). 32 patients had fibromyalgia. After excluding them, we found a statistically and clinically significantly better clinical response to depomedrone in patients with US-synovitis at baseline (baseline-adjusted EMS VAS at 2 weeks -12mm, 95% CI -24, 0mm, p=0.049). This difference was greater in the treatment-adjusted sensitivity analysis (-12.8 (95% CI -22, -3mm), p=0.007) and the per-protocol-adjusted sensitivity analysis (-14.8mm (95% CI -20.8, -8.8mm), p<0.001). Patient with US synovitis had higher rates of improvement in the MSK BILAG-2004 (56% vs. 26%, p=0.09) and SLEDAI-2K (37% vs. 15%, p=0.03).Conclusion:In lupus arthritis, distribution and serology, but not other features, help identify US-synovitis. US-synovitis was independent of features of fibromyalgia, but fibromyalgia confounded assessment of clinical response. US should be used to select SLE arthritis patients for therapy and clinical trials, especially when there are inflammatory symptoms without swollen joints.Acknowledgments:The Project was funded by Lupus-UKDisclosure of Interests:Khaled Mahmoud: None declared, Ahmed Zayat: None declared, Md Yuzaiful Md Yusof: None declared, Katherine Dutton: None declared, Lee-Suan Teh: None declared, Chee-Seng Yee: None declared, David d’cruz Grant/research support from: GlaxoSmithKline, Nora Ng: None declared, David Isenberg Consultant of: Study Investigator and Consultant to Genentech, Coziana Ciurtin Grant/research support from: Pfizer, Consultant of: Roche, Modern Biosciences, Philip G Conaghan Consultant of: AbbVie, BMS, Eli Lilly, EMD Serono, Flexion Therapeutics, Galapagos, GSK, Novartis, Pfizer, Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Christopher Edwards Grant/research support from: Abbvie, Biogen, Roche, Consultant of: Abbvie, Samsung, Speakers bureau: Abbvie, BMS, Biogen, Celgene, Fresenius, Gilead, Janssen, Lilly, Mundipharma, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, UCB, Elizabeth Hensor: None declared, Edward Vital Grant/research support from: AstraZeneca, Roche/Genentech, and Sandoz, Consultant of: AstraZeneca, GSK, Roche/Genentech, and Sandoz, Speakers bureau: Becton Dickinson and GSK

scholarly journals Minimal Disease Activity as a Treatment Target in Psoriatic Arthritis: A Review of the Literature

2017 ◽  
Vol 45 (1) ◽  
pp. 6-13 ◽  
Author(s):  
Laure Gossec ◽  
Dennis McGonagle ◽  
Tatiana Korotaeva ◽  
Ennio Lubrano ◽  
Eugenio de Miguel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Health Assessment ◽  
Severity Index ◽  
Inflammatory Rheumatic Diseases ◽  
Functional Evaluation ◽  
Minimal Disease Activity ◽  
Treatment Target ◽  
Minimal Disease

As in other inflammatory rheumatic diseases, the objective of psoriatic arthritis (PsA) treatment is the achievement of a defined target. Recent recommendations propose aiming for remission or low disease activity; however, a consensual definition of remission is lacking. A state of minimal disease activity (MDA) has been established and is defined by low activity assessed by tender/swollen joint counts, tender entheseal points, Psoriasis Area and Severity Index or body surface area, patient pain and global activity visual analog scale, and functional evaluation by Health Assessment Questionnaire. Since its development, MDA has been used increasingly in studies and clinical trials. In this article, the potential use of MDA as a treatment target in PsA is reviewed. The frequencies of MDA achievement with biologic disease-modifying antirheumatic drugs are summarized based on data from registries, observational studies, and clinical trials. Predictors and the prognostic effect of attaining MDA are also evaluated.

Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment

2009 ◽  
Vol 69 (01) ◽  
pp. 48-53 ◽  
Author(s):  
L C Coates ◽  
J Fransen ◽  
P S Helliwell
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Area Under The Curve ◽  
High Specificity ◽  
Visual Analogue Score ◽  
Severity Index ◽  
Tender Joint Count ◽  
Minimal Disease Activity ◽  
Tender Joint ◽  
Minimal Disease

Objective:To create minimal disease activity (MDA) criteria for psoriatic arthritis (PsA). With recent therapeutic advances, this is now a goal for treatment and may represent a measure to compare therapies. It defines a satisfactory state of disease activity rather than a change, and encompasses all aspects of the disease.Methods:40 patient profiles were sampled from an observational PsA database. Sixty experts in PsA classified these as in MDA or not. A consensus of ⩾70% was accepted, identifying 13 profiles in MDA. Summary statistics created possible cut-off points for the definition. Considering the number of measures that must be met, 35 candidate definitions were created and tested using receiver operating characteristic curves (ROC) for sensitivity and specificity.Results:Four candidate definitions showed high area under the curve values on ROC testing. Definitions with high outlying values were excluded as they were not considered to represent MDA. Aiming for high specificity to reduce false positives resulted in a preference for the following definition: “A patient is classified as achieving MDA when meeting 5 of the 7 following criteria: tender joint count ⩽1; swollen joint count ⩽1; Psoriasis Activity and Severity Index ⩽1 or body surface area ⩽3; patient pain visual analogue score (VAS) ⩽15; patient global disease activity VAS ⩽20; health assessment questionnaire ⩽0.5; tender entheseal points ⩽1”.Conclusion:This study provides the first definition of a “state” of MDA in PsA and defines a target for treatment. It must now be validated in other populations and tested in clinical trials.

scholarly journals AB0558 CLINICAL EFFECTIVENESS AND SAFETY OF ADALIMUMAB VERSUS NON-BIOLOGIC THERAPY IN PSORIATIC ARTHRITIS PATIENTS OVER 24 MONTHS – RESULTS OF THE COMPLETE-PsA CANADIAN OBSERVATIONAL STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1314-1315
Author(s):  
M. Khraishi ◽  
J. Stewart ◽  
Y. Setty ◽  
M. C. Laliberté ◽  
L. Bessette
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Therapeutic Response ◽  
Clinical Effectiveness ◽  
Advisory Board ◽  
Minimal Disease Activity ◽  
Research Support ◽  
Das 28 ◽  
Minimal Disease ◽  
Response Thresholds

Background:COMPLETE-PsA was an observational study of biologic-naïve Canadian adults with active psoriatic arthritis (PsA) treated with adalimumab or non-biologic disease-modifying anti-rheumatic drugs (nbDMARD) after switch from initial therapy.Objectives:The aim of this analysis was to assess the 24-month clinical effectiveness and safety of adalimumab vs. nbDMARD in the treatment of PsA in a real-life setting.Methods:Eligible patients were biologic naïve adults, with active PsA who required change in their treatment regimen due to inadequate response or intolerance, per the judgment of the treating physician. Patients were enrolled between July/2011 and December/2017 and followed for up to 24 months. Patients were treated as per routine care. The primary endpoint, change in DAS-28 to month 24, was assessed with baseline-adjusted multivariable models and the least square mean (LSM) estimates were generated; Physician’s Global Assessment of disease activity (PGA, 100mm VAS) was assessed using similar methodology. Probability of achieving the following therapeutic response thresholds was ascertained and odds ratios (ORs) were generated: 50%/70% improvement in the American College of Rheumatology criteria (ACR50/ACR70), DAS-28<3.2 (low disease activity or remission; LDA/remission), DAS-28<2.6 (remission), modified minimal disease activity (mMDA: achievement of 5/7 of: TJC and SJC ≤1 each, BSA ≤3%, pain ≤15 (VAS, mm), Patient Global Assessment [PtGA] ≤20, HAQ-DI ≤0.5, and no enthesitis), and psoriasis (PsO) BSA <3%.Results:A total of 277 adalimumab and 148 nbDMARD- treated patients were included as part of the intent-to-treat population. Baseline methotrexate was reported by 61.7% and 81.1% of adalimumab and nbDMARD-treated patients, respectively. PsO BSA at baseline was predominantly <3% for both adalimumab (60.2%) and nbDMARD (64.6%) patients. Adalimumab-treated patients reported significantly (p<0.05) higher mean (SD) disease activity for both DAS-28 [4.8 (1.2) vs. 4.3 (1.1)] and PGA [59.4 (19.5) vs. 51.0 (21.8) mm] at baseline.For the primary endpoint, baseline-adjusted month 24 DAS-28 levels were significantly lower for adalimumab vs. nbDMARD patients [LSM (95%CI): 2.4 (2.2-2.6) vs. 3.0 (2.7-3.3); p=0.037]. In addition, rapid and sustained reductions in DAS-28 were observed for adalimumab-treatment patients, with overall treatment effect significant (p<0.001) in favor of adalimumab [estimate (95%CI): -1.1 (-1.4, -0.7)]; similar results were observed for PGA [-12.9 (-1.7, -8.0)]. Adalimumab-treated patients were at significantly higher (p<0.001) odds of attaining therapeutic response thresholds compared to DMARD-treated patients, specifically: DAS-28 LDA/remission [OR (95%CI): 4.5 (2.8, 7.3)] or remission [OR (95% CI): 4.1 (2.7-6.3)], ACR50 [OR (95% CI): 3.0 (2.0-4.6)], ACR70 [OR (95% CI): 3.1 (2.0-4.9)], mMDA [OR (95% CI): 2.4 (1.6-3.6)], and PsO BSA <3% [OR (95% CI): 2.2 (1.2-3.7)].Overall, 32 (10.7%) of adalimumab-treated patients reported 86 AEs, the most common related to infections [16 events in 10 (3.3%) patients].Conclusion:Real-world treatment with adalimumab was more effective in improving disease activity and psoriasis severity, over 24 months when compared to nbDMARDs and was associated with significantly greater likelihood of achieving minimal disease activity. Observed AEs were consistent with the established safety profile of adalimumab.Disclosure of Interests:Majed Khraishi Speakers bureau: Speaker for AbbVie, Consultant of: Consultant for AbbVie, Grant/research support from: Principal Investigator for AbbVie, Jacqueline Stewart Speakers bureau: Speaker for Abbvie, Janssen, and Johnson & Johnson, Consultant of: Advisory Board Consultant for AbbVie, Amgen, Celgene, Merck, Novartis, Pfizer, and Sanofi-Genzyme;, Grant/research support from: Participated in research with AbbVie, Bristol Myers Squibb, Janssen, and Roche, Yatish Setty Consultant of: Advisory Board meetings with AbbVie and Janssen, Marie-Claude Laliberté Employee of: Employee of AbbVie, Louis Bessette Speakers bureau: Speaker for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Gilead, Sandoz, and Fresenius Kabi, Consultant of: Consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Gilead, Sandoz, Samsung Bioepis, and Fresenius Kabi, Grant/research support from: Investigator for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, and Gilead.

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