Clinical Characteristics, Disease Activity, and Patient-Reported Outcomes in Psoriatic Arthritis Patients With Dactylitis or Enthesitis: Results From the Corrona Psoriatic Arthritis/Spondyloarthritis Registry

2017 ◽  
Vol 69 (11) ◽  
pp. 1692-1699 ◽  
Author(s):  
Philip J. Mease ◽  
Chitra Karki ◽  
Jacqueline B. Palmer ◽  
Carol J. Etzel ◽  
Arthur Kavanaugh ◽  
...  
2016 ◽  
Vol 76 (1) ◽  
pp. 203-207 ◽  
Author(s):  
Vibeke Strand ◽  
Philip Mease ◽  
Laure Gossec ◽  
Ori Elkayam ◽  
Filip van den Bosch ◽  
...  

ObjectiveTo evaluate the effect of secukinumab on patient-reported outcomes (PROs) in subjects with active psoriatic arthritis (PsA) in the FUTURE 1 study.MethodsSubjects were randomised 1:1:1 to receive intravenous (i.v.) secukinumab 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous secukinumab 150 or 75 mg every 4 weeks or matching placebo until week 24.ResultsAt week 24, subjects receiving secukinumab i.v.→150 mg or i.v.→75 mg reported greater least squares mean changes from baseline than those receiving placebo in patient global assessment of disease activity (−20.6 and −20.0 vs −7.4, respectively), patient assessment of pain (−20.8 and −20.4 vs −6.7), psoriatic arthritis quality of life (−3.5 and −3.2 vs −0.4), Dermatology Life Quality Index (−8.8 and −7.9 vs 0.7); p<0.0001 vs placebo for both secukinumab groups for above PROs and Functional Assessment of Chronic Illness Therapy-Fatigue (6.74 (p<0.05 vs placebo) and 6.03 vs 4.00); all of which well exceeded minimum clinically important differences.ConclusionsIn subjects with PsA, secukinumab treatment resulted in clinically meaningful improvements in global disease activity, pain, generic and disease-specific measures of health-related quality of life and fatigue.Trial registration numberNCT01392326; Results.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1312.2-1313
Author(s):  
M. Khraishi ◽  
S. Silverberg ◽  
Y. Setty ◽  
M. C. Laliberté ◽  
L. Bessette

Background:COMPLETE-PsA was a Canadian observational study of biologic-naïve adults with active psoriatic arthritis (PsA) treated with adalimumab (ADA) or conventional systemic disease-modifying anti-rheumatic drugs (csDMARDs) after switch from a previous conventional therapy.Objectives:To compare the impact of ADA vs csDMARDs on clinical and patient-reported outcomes due to PsA over 24 months.Methods:Eligible patients were biologic naïve adults with active PsA who required change in their treatment due to inadequate response or non-tolerance, as per treating physician judgement. Patients were enrolled between July/2011 and December/2017 and followed for a maximum 24 months. Treatment was as per routine care. Outcome measures included tender/swollen joint count (TJC/SJC), morning stiffness (min/day), patient’s global assessment of disease activity (PtGA) and pain (both 100 mm VAS), quality of life (DLQI), and functional disability (HAQ-DI). Outcome changes over time were evaluated using multivariable models adjusting for baseline measures. Achievement of modified minimal disease activity [mMDA, 5/7 of: TJC and SJC ≤1 each, psoriasis BSA ≤3%, pain ≤15 (VAS, mm), PtGA ≤20, HAQ-DI ≤0.5, and no enthesitis], and presence of enthesitis and dactylitis, were assessed descriptively. Analyses were conducted in the intent-to-treat population.Results:A total of 277 ADA and 148 csDMARD-treated patients were included in the analysis. At baseline, 61.7% of ADA and 81.1% of csDMARD patients reported concomitant methotrexate. Compared to the csDMARD group, ADA-treated patients demonstrated significantly (p<0.05) greater baseline disease severity with respect to mean (SD) joint count [TJC: 8.9 (6.2) vs. 7.4 (6.6); SJC: 7.4 (5.0) vs. 5.9 (4.6)], morning stiffness [83.5 (98.2) vs. 61.8 (77.4) min/day], PtGA [56.1 (24.1) vs. 45.1 (24.7) mm], pain [58.5 (24.3) vs. 50.1 (24.0) mm], DLQI scores [6.1 (6.9) vs. 4.3 (5.3)] and HAQ-DI [1.1 (0.6) vs. 0.8 (0.6)]. The rate of baseline mMDA was slightly lower for ADA patients (4.3% vs. 7.4%; p=0.178). Baseline prevalence of enthesitis was comparable (ADA: 28.4% vs. csDMARD: 23.4%; p=0.276), while dactylitis was significantly more prevalent for csDMARD patients (26.2% vs. 36.3%; p=0.031).Overall effect of treatment group, over 24 months, significantly (p<0.05) favored the ADA vs. csDMARD-treated patients for TJC [estimate (95%CI): -2.4 (-3.4, -1.4)] SJC [-1.8 (-2.5, -1.2)], PtGA [-3.7 (-9.3, 1.9)], DLQI [-1.5 (-2.5, -0.5)], and HAQ-DI [-0.1 (-0.2, 0.0)] (Figure 1). There was no significant difference for morning stiffness and pain.At month 24, statistically comparable (p>0.05) baseline-adjusted values (the least square means: LSM) were observed for ADA- vs. csDMARD-treated patients for TJC [LSM (95%CI): 1.8 (1.2, 2.4) vs. 3.0 (2.1, 3.8)], SJC [1.2 (0.8, 1.7) vs. 2.1 (1.5, 2.7)], morning stiffness [32.4 (19.1, 45.6) vs. 29.9 (11.1, 48.6) min/day], PtGA [31.6 (28.1, 35.2) vs. 36.9 (31.8, 41.9) mm], pain [35.3 (31.5, 39.0) vs. 38.4 (33.1, 43.7) mm], DLQI [2.9 (2.2, 3.6) vs. 2.9 (2.0, 3.8)], and HAQ-DI [0.7 (0.6, 0.8) vs. 0.9 (0.8, 1.0)].Achievement of mMDA at month 24 was reported by 34.1% and 34.9% of ADA- and csDMARD-treated patients, respectively (p=0.892). Rates of dactylitis (10.6% vs. 10.0%) and enthesitis (9.6% vs. 14.4%) were comparable in the ADA vs. csDMARDs groups respectively.Conclusion:The results of this real-world Canadian study indicate a physician selection bias for treatment with ADA for PsA patients with more severe disease burden, indicated by greater baseline disease activity and PROs. ADA-treated patients experienced a greater treatment effect over 24 months compared to csDMARD-treated patients. However, despite the greater treatment effect of ADA, residual disease burden in the two groups was comparable at 24 months.Acknowledgements:The authors wish to acknowledge JSS Medical Research for their contribution to the statistical analysis, medical writing, and editorial support during the preparation of this abstract. AbbVie provided funding to JSS Medical Research for this work.Disclosure of Interests:Majed Khraishi Speakers bureau: Speaker for AbbVie, Consultant of: Consultant for AbbVie, Grant/research support from: Principal Investigator for AbbVie, Samuel Silverberg Consultant of: Consultant for AbbVie, Janssen, and Pfizer, 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, Fresenius Kabi, Consultant of: Consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Gilead, Sandoz, Samsung Bioepis, Fresenius Kabi, Grant/research support from: Investigator for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Gilead.


2017 ◽  
Vol 44 (8) ◽  
pp. 1151-1158 ◽  
Author(s):  
Philip J. Mease ◽  
Chitra Karki ◽  
Jacqueline B. Palmer ◽  
Carol J. Etzel ◽  
Arthur Kavanaugh ◽  
...  

Objective.Psoriatic arthritis (PsA) is commonly comorbid with psoriasis; the extent of skin lesions is a major contributor to psoriatic disease severity/burden. We evaluated whether extent of skin involvement with psoriasis [body surface area (BSA) > 3% vs ≤ 3%] affects overall clinical and patient-reported outcomes (PRO) in patients with PsA.Methods.Using the Corrona PsA/Spondyloarthritis Registry, patient characteristics, disease activity, and PRO at registry enrollment were assessed for patients with PsA aged ≥ 18 years with BSA > 3% versus ≤ 3%. Regression models were used to evaluate associations of BSA level with outcome [modified minimal disease activity (MDA), Health Assessment Questionnaire (HAQ) score, patient-reported pain and fatigue, and the Work Productivity and Activity Impairment questionnaire score]. Adjustments were made for age, sex, race, body mass index, disease duration, and history of biologics, disease-modifying antirheumatic drug, and prednisone use.Results.This analysis included 1240 patients with PsA with known BSA level (n = 451, BSA > 3%; n = 789, BSA ≤ 3%). After adjusting for potential confounding variables, patients with BSA > 3% versus ≤ 3% had greater patient-reported pain and fatigue and higher HAQ scores (p = 2.33 × 10−8, p = 0.002, and p = 1.21 × 10−7, respectively), were 1.7× more likely not to be in modified MDA (95% CI 1.21–2.41, p = 0.002), and were 2.1× more likely to have overall work impairment (1.37–3.21, p = 0.0001).Conclusion.These Corrona Registry data show that substantial skin involvement (BSA > 3%) is associated with greater PsA disease burden, underscoring the importance of assessing and effectively managing psoriasis in patients with PsA because this may be a contributing factor in PsA severity.


RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000867 ◽  
Author(s):  
Philip J Mease ◽  
Carol J Etzel ◽  
William J Huster ◽  
Talia M Muram ◽  
April W Armstrong ◽  
...  

ObjectiveTo compare the characteristics of patients with psoriatic arthritis among patient groups stratified by degree of skin and joint involvement, and to evaluate the relationship between skin severity and joint activity.MethodsBody surface area (BSA) and Clinical Disease Activity Index (CDAI) at enrolment were analysed. Patient characteristics were stratified by skin severity and joint activity. Baseline patient characteristics, clinical and disease characteristics and patient-reported outcomes were compared. The strength of the relationship of skin severity and joint activity was evaluated using methods for categorical variables (χ2 test, Cramer’s V) and continuous variables (linear regression).Results1542 adult patients in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry enrolled between 21 May 2013 and 20 September 2016 were analysed. Most patients in the BSA >3%/CDAI moderate/high subgroup had worse clinical and patient-reported outcomes. A significant (p<0.001) modest association (Cramer’s V=0.1639) between skin severity and joint activity was observed among all patients at enrolment. Patients with higher skin severity were two times more likely to have higher joint involvement (OR 2.27, 95% CI 1.71 to 3.01). A significant linear relationship between CDAI and BSA was observed. Effect modification showed this linear relationship was modified by age, gender, insurance, work status, current therapy, Health Assessment Questionnaire, Nail visual analogue scale, minimal disease activity, dactylitis count, patient-reported pain and fatigue.ConclusionSkin severity is modestly correlated with joint activity, and patients with higher skin severity are two times more likely to have increased joint involvement. Clinicians need to address both skin severity and joint activity in treatment decisions.


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Laura C. Coates ◽  
Andrew G. Bushmakin ◽  
Oliver FitzGerald ◽  
Dafna D. Gladman ◽  
Lara Fallon ◽  
...  

Abstract Background In psoriatic arthritis (PsA), further understanding of the relationships between clinical measures and patient-reported outcomes (PROs) is needed. This post hoc analysis evaluated associations between minimal disease activity (MDA) as a continuous outcome (termed ScoreMDA) or Psoriatic Arthritis Disease Activity Score (PASDAS) with selected PROs not included in the composite measures. Methods Data from two phase 3 studies of tofacitinib in PsA (OPAL Broaden [NCT01877668; N = 422]; OPAL Beyond [NCT01882439; N = 394]) were included. MDA (binary outcome) was defined as meeting ≥5/7 criteria. For ScoreMDA, each criterion was assigned a value (1 = true; 0 = false; score range, 0–7; scores ≥5 indicated MDA). For PASDAS (score range, 0–10), higher scores indicated worse disease activity. PROs analyzed included Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Patient’s Assessment of Arthritis Pain visual analog scale (Pain VAS), and EuroQoL-Five Dimensions-Three Level Health Questionnaire visual analog scale (EQ-5D-3L VAS) and utility index. Relationships were evaluated using repeated measures regression models. Results Similar, approximately linear relationships were confirmed between PASDAS or ScoreMDA and PROs in both studies. In OPAL Broaden and OPAL Beyond, a one-point difference in PASDAS was associated with clinically relevant differences in PROs, including EQ-5D-3L VAS (− 6.7 mm, − 6.9 mm), Pain VAS (9.9 mm, 10.7 mm), and FACIT-F (− 2.8, − 3.3). A one-point difference in ScoreMDA was associated with clinically relevant differences in PROs, including EQ-5D-3L VAS (5.0 mm, 5.5 mm) and FACIT-F (1.9, 2.7) in OPAL Broaden and OPAL Beyond, respectively. Conclusions Linear associations between PASDAS or ScoreMDA and PROs provide interpretable and quantifiable metrics between composite clinical measures and PROs, highlighting the importance of these measures in understanding the relevance of treat-to-target goals in PsA. Trial registration ClinicalTrials.gov, NCT01877668. Registered on June 12, 2013. ClinicalTrials.gov, NCT01882439. Registered on June 18, 2013


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 668.2-669
Author(s):  
S. Monti ◽  
P. Delvino ◽  
C. Klersy ◽  
G. Coppa ◽  
A. Milanesi ◽  
...  

Background:Patient-reported outcomes (PROs) are currently poorly integrated in the clinical evaluation of disease activity in patients with ANCA-associated vasculitis (AAV).Objectives:To assess the distribution of the Patient Global Assessment (PtGA) in patients with AAV in stable remission, and to identify correlates of PtGA; to assess the discordance between PtGA score and PhGA.Methods:Patients with a diagnosis of AAV [eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, microscopic polyangiitis] in stable, complete remission (defined by a BVAS=0) and with a Physician Global Assessment (PhGA)=0 were included. A questionnaire including several aspects of disease captured by PROs was collected. PtGA on a 0-100 mm visual analogue scale (VAS) was assessed, with higher scores representing higher/worse levels of disease activity. Similarly, VAS for pain, chronic damage according to the patient’s opinion, general health (GH), fatigue, and sleep quality were collected. The worst symptom in the patient’s opinion affecting the overall assessment of disease activity was recorded. The Cragg Hurdle model was used to assess the predictors of PtGA.Results:65 patients were included, female 57%, mean age 61±12 years. Mean disease duration at enrollment was 8±6 years. Mean vasculitis damage index (VDI) was 4.4 ±2.3, with 45% of patients having a VDI ≥ 5. Despite having been classified as being in remission, PtGA was elevated in 37% of patients. We explored several correlates of PtGA. Higher degree of damage accrual (VDI) did not influence the patient’s evaluation of current disease activity. Similarly, we did not identify a correlation between older age, educational level, number of organ-systems involved, number of comorbidities, the number of previous major or minor relapses, higher disease duration, nor the type of AAV diagnosis (figure 1, panel A). Only sex significantly correlated with PtGA scores: 19 (51%) of female patients reported an elevated PtGA compared to only 5 (18%) of male (p=0.009). PtGA resulted to be significantly correlated with other (mostly modifiable) PROs including VAS pain, perception of the level of chronic damage accrual, GH, and fatigue (figure 1, panel B). The agreement between patients’ and physicians’ assessments of disease activity was 63%. Patients reported pain, followed by chronic respiratory symptoms to be the worst-experienced ongoing manifestations affecting their evaluation of disease activity.Conclusion:A significant proportion of patients with AAV considered to be in remission by the physician still declares to have persistent aspects of uncontrolled disease. PtGA is significantly influenced by persistent pain and fatigue, which warrant better assessment in the future.Disclosure of Interests:None declared


Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Fiammetta Danzo ◽  
Klodian Gjeloshi ◽  
Giovanni Lettieri ◽  
Giuseppina Abignano ◽  
Mark Hinton ◽  
...  

Abstract Background Neointima proliferation is a key pathologic feature of systemic sclerosis (SSc), causing arterial vessel narrowing and being the recognised culprit pathological lesion in digital ulcers (DUs), pulmonary artery hypertension and renal crisis. Nevertheless, there are no validated imaging techniques to assess the severity of vascular involvement in SSc. We have previously shown digital artery volume index (DAVIX©) assessed with time of right MRI angiography, is a reliable measure of neointima proliferation in the hands. The purpose of our study was to identify the value of DAVIX© in predicting worsening of patient reported outcomes (PROs) and clinical parameters in SSc. Methods Cross-sectional data were available for 91 patients and complete 12 months follow-up data for 68 patients. Data collected included: modfied Rodnan skin score (mRSS), pulmonary function tests (PFTs), echocardiography, nailfold capillaroscopy, Health Assessment Questionnaire Disability Index (HAQ-DI), and Scleroderma Health Assessment Questionnaire (sHAQ). DAVIX© of the dominant hand was calculated as the % mean of the 4 fingers, employing MeVisLab software. Following analysis of distribution, Spearman or Pearson test were used to determine correlation coefficients, as appropriate (Prism 7). Results 56/68 were female and median of disease duration was 4 years (IQR 1.91-9). As previously reported DAVIX© correlated with the presence of DUs (p = 0.0093). Considering all patients, DAVIX© correlated with mRSS (r=-0.258, p = 0.017), DLCO% (r = 0.338, p = 0.008) and the pattern of capillaroscopy (r=-0.388, p = 0.001). In patients with DUs, DAVIX© showed a stronger correlation with DLCO% (r = 0.786, p = 0.048). Most importantly, DAVIX© predicted the worsening of HAQ-DI (r=-0.295, p = 0.029), sHAQ (r =-0.333, p = 0.029) and VAS pain (r=-0.269, p = 0.038) independently of the presence of DUs. Conclusion The quantitative assessment of neointima proliferation in the hand by DAVIX© is a useful imaging biomarker of vascular disease activity. The value of DAVIX© in predicting the worsening of PROs and clinical parameters in overall patients, may offer insights on the role of vascular disease activity in the global progression of SSc. The validation of our data in an independent cohort and the sensitivity to change over time of DAVIX© may aid to the implementation of hand MRI as imaging outcome measure of vascular severity in SSc. Disclosures F. Danzo None. K. Gjeloshi None. G. Lettieri None. G. Abignano None. M. Hinton None. A. Dean None. G. Cuomo None. O. Kubassova None. F. del Galdo None.


RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000765 ◽  
Author(s):  
Silva Pukšić ◽  
Pernille Bolton-King ◽  
Joseph Sexton ◽  
Brigitte Michelsen ◽  
Tore K Kvien ◽  
...  

ObjectivesDisease Activity index for PSoriatic Arthritis (DAPSA) (sum score 68/66 tender/swollen joint counts (68TJC/66SJC), patient’s global assessment, pain and C-reactive protein (CRP)) is recommended for clinical assessment of disease activity in patients with psoriatic arthritis (PsA). Ultrasound (US) (grey scale (GS) and power Doppler (PD)) detects inflammation in joints and extra-articular structures. The present objectives were to explore the longitudinal relationships between DAPSA, clinical assessment as well as patient-reported outcome measures (PROMs) with US in patients with PsA initiating biological DMARDs and the associations between DAPSA and US remission.Methods47 patients with PsA were examined at baseline and after 3, 6, 9 and 12 months. Assessments included 68TJC/66SJC, examiner’s global assessment (EGA), PROMs, CRP, erythrocyte sedimentation rate (ESR) and US GS and PD (48 joints, 10 flexor tendons, 14 entheses, 4 bursae). Clinical composite scores and PD sum scores (0=remission) were calculated. Longitudinal associations were explored by generalised estimating equations with linear and logistic regression.ResultsDAPSA was not longitudinally associated to PD. 66SJC, ESR, 28-joint Disease Activity Score, EGA and CRP were longitudinally associated with PD (p<0.001–0.03), whereas the pain-related components of DAPSA (68TJC and pain) as well as PROMs were not associated. At 6–12 months, remission was achieved in 29%–33 % of the patients for DAPSA and 59%–70 % for PD. The association between DAPSA and PD remission was not significant (p=0.33).ConclusionsDAPSA was not associated with US inflammatory findings which indicates that DAPSA and US may assess different aspects of PsA activity.


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