scholarly journals POS0976 ANALYSIS OF BIOLOGIC THERAPY RETENTION RATE IN PSORIATIC ARTHRITIS PATIENTS WITH AND WITHOUTV AXIAL INVOLVEMENT. DATA FROM CLINICAL PRACTICE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 754-755
Author(s):  
E. Gubar ◽  
Y. Korsakova ◽  
E. Loginova ◽  
S. Glukhova ◽  
T. Korotaeva ◽  
...  

Background:Limited data are available on retention rates of biologic therapy in psoriatic arthritis (PsA) patients (pts) with axial involvement. It has been shown that in the subset of pts with prevalent axial involvement (AS versus PsA and AxSpA versus PsA) a longer duration of anti-TNF-α-therapy was observed as compared to peripheral arthritis [1].Objectives:To compare retention rates of biologic therapy in PsA pts with and without axial involvement in routine clinical practice.Methods:731 pts with PsA according to CASPAR criteria were included in the study. Data were collected from 43 rheumatology clinics over various regions of the Russian Federation. Among the pts, 243 (33.0%) (M/F 132/111) were given biologic therapy. Pts’ age 45.9±12.8 years (yrs), disease duration 8.6±6.5 yrs. Pts underwent standard clinical examination of PsA activity and were split into two groups (gr.), with and without axial PsA (axPsA): axPsA(+) and axPsA(-). Pts in the axPsA(+) gr. had inflammatory back pain by ASAS criteria and/or radiographic sacroiliitis (SI) (unilateral grade≥3 or bilateral grade≥2) and/or active MRI SI and/or typical of axPsA changes of the cervical and/or lumbar spine (marginal/paramarginal syndesmophytes, ankylosis of the facet joints). Pts in the axPsA(-) gr. had only peripheral arthritis. The axPsA(+) gr. included 143 (58.8%) pts, the axPsA(-) gr. 100 (41.2%) pts. 163 (67.1%) pts were treated with TNF inhibitors (TNF-i), 80 (32.9%) pts with interleukin inhibitors (IL-i): 55 pts with Ustekinumab, 25 pts with Secukinumab. During the TNF-i treatment courses Infliximab was given to 34 pts, Adalimumab to 53 pts, Etanercept to 36 pts, Golimumab to 27 pts and Certolizumab Pegol to 8 pts. The observation period lasted 12 months. Treatment retention rates were analyzed using Kaplan-Meier curves and the log-rank test.Results:Analysis of the treatment retention rates revealed statistically significant differences between the axPsA(+) and the axPsA(-) grs. After 12 months of observation, 72.9% of pts in the axPsA(-) gr. continued receiving biologic therapy, while in the axPsA(+) gr. only 53.1% of pts (р=0.0027) received it. The same kind of differences in anti-TNF therapy were found between the axPsA(-) gr. and the axPsA(+) gr.: 82.2% and 62.3% pts respectively (р=0.011) continued receiving TNF-i after 12 months. However no statistically significant differences were found between the two grs. in the treatment retention rates of IL-i therapy: after 12 months of observation 55.5% of axPsA(-) pts and 37% of axPsA(+) pts (р=0.086) continued receiving IL-i.Conclusion:In routine clinical practice, retention rates of biologic therapy were found to be worse in PsA pts with axial involvement. In clinical practice, TNF-i are prescribed twice as often than IL-i. However, considering the need of personalized therapy, in case of axPsA the use of IL-i is preferable because their treatment retention rates don’t depend on axial involvement.References:[1]M. Fabbroni et al. Mediators of Inflammation, 2014.Retention rates of biologic therapy. Differences between axPsA(+) and axPsA(-) pts are statistically significant (р=0.00265, log rank test).Disclosure of Interests:None declared.

Medicina ◽  
2020 ◽  
Vol 56 (11) ◽  
pp. 584
Author(s):  
Cristina Galache Osuna ◽  
Borja Gómez-Vila ◽  
Javier Aubán Pariente ◽  
Beatriz Vázquez Losada ◽  
Celia Gómez de Castro ◽  
...  

Background and objectives: The efficacy and safety of ustekinumab have been proved in clinical trials. In daily clinical practice, knowing the factors that determine survival differences of biological drugs allows psoriasis treatment to be optimized as a function of patient characteristics. The main objectives of this work are to understand ustekinumab drug survival in patients diagnosed with plaque psoriasis in the Hospital Universitario Central de Asturias (HUCA Dermatology Department, and to identify the predictors of drug discontinuation. Materials and Methods: A retrospective hospital-based study, including data from 148 patients who were receiving ustekinumab (Stelara®) between 1 February 2009 and 30 November 2019, were collected. Survival curves were approximated through the Kaplan–Meier estimator and compared using the log-rank test. Proportional hazard Cox regression models were used for multivariate analyses while both unadjusted and adjusted hazard ratios (HR) were used for summarizing the studied differences. Results: The average duration of the treatment before discontinuation was 47.57 months (SD 32.63 months; median 41 months). The retention rates were 82% (2 years), 66% (5 years), and 58% (8 years). Median survival was 80 months (95% confidence interval. CI 36.9 to 123.01 months). The survival study revealed statistically significant differences between patients with arthritis (log-rank test, p < 0.001) and those who had previously received biological treatment (log-rank test, p = 0.026). The five-year prevalence in patients still under treatment was 80% (those without arthritis) and 54% (arthritis patients). In the multivariate analysis, only the patients with arthritis had a lower rate of drug survival. No statistically significant differences were observed for any of the other comorbidities studied. The first and second most frequent causes of discontinuation were secondary failure and arthritis inefficacy, respectively. Conclusion: Ustekinumab is a biological drug conferring high survival in plaque psoriasis patients. Ustekinumab survival is lower in patients with arthritis.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1303.2-1304
Author(s):  
J. Gratacos-Masmitja ◽  
J. L. Álvarez Vega ◽  
E. Beltrán ◽  
A. Urruticoechea-Arana ◽  
C. Fito-Manteca ◽  
...  

Background:Apremilast is a non-biologic systemic agent approved for the treatment of plaque psoriasis, oral ulcers of Behcet’s disease and PsA with proven efficacy in clinical trials [1,2]. However, more real-world evidence of apremilast use and effectiveness is needed to identify the patient profile most likely to benefit from this treatment [3].Objectives:To evaluate the persistence of apremilast treatment in patients with PsA naïve to biological treatments in routine clinical practice and assess its effectiveness. Baseline clinical characteristics on patients who started apremilast were also evaluated.Methods:Observational, prospective, multicenter (20 centers) study including consecutive adult patients with PsA naïve to biological therapies who had started treatment with apremilast during the previous 5 to 7 months and were followed-up during 12 months. Variables recorded were persistence of treatment with apremilast at 6 months (6mo) and number of swelling joints, presence of enthesitis and dactylitis, and disease activity, measured by the Disease Activity in Psoriatic Arthritis (DAPSA) score and Physician Global Assessment (PGA) of psoriasis, collected at baseline (BL) (i.e., apremilast treatment start) and 6mo; comorbidities were retrospectively collected at BL. Categorical and quantitative variables were compared using McNemar’s and Wilcoxon test, respectively. Data sets analyzed included all assessable patients.Results:Of the 60 patients recruited at the time of this interim analysis, 54 (90.0%) [mean (SD) age 53.4 (13.9) years] were assessable; 41 (75.9%) of these continued treatment with apremilast at 6mo. At BL, 34 (63.0%) patients had at least one comorbidity, the most frequent being cardiovascular disease (n=15, 27.8%), including hypertension (n=8, 14.8%), metabolic/endocrine disease (n=18, 33.3%), including obesity (n=8, 14.8%) and dyslipidemia (n=10, 18.5%). Psychiatric disease (i.e., depression) (n=5, 9.3%) and neoplasia (n=8, 14.8%) were also observed. The number of swelling joints decreased from median (Q1, Q3) 4.0 (2.0, 7.0) at BL to 1.5 (0.0, 4.0) at 6mo (p=0.0012). Patients with dactylitis and enthesitis decreased from 19 (35.2%) and 16 (29.6%) at BL to 10 (18.5%) and 9 (16.7%) at 6mo (p=0.0225 and p=0.0391), respectively. The distribution of patients in the different disease activity categories according to DAPSA scale changed between BL and 6mo, indicating a favorable disease evolution (Figure 1 next page). According to PGA, at BL (n=53), disease activity was categorized as mild in 18.0%, as moderate in 72.0%, and as severe in 10% of patients and, at 6mo (n=54), as mild in 70.6%, as moderate in 25.5%, and as severe in 3.9% of patients. Fifteen (27.8%) patients interrupted treatment permanently (n=13, 24.1%) or temporarily (n=2, 3.7%), due to no/partial response (n=8, 14.8%), tolerability issues leading to adverse events (n=3, 5.6%), patient decision (n=2, 3.7%), and other reasons (n=2, 3.7%) after a mean (SD) treatment of 3.05 (2.20) months.Conclusion:Forty-one (75.9%) patients with PsA naïve to biological therapies were treated with apremilast during ≥6 months. After treatment, the number of swelling joints, and dactylitis and enthesitis decreased and changes in disease activity according to DAPSA and PGA pointed to a favorable disease evolution. Apremilast treatment provides a clinical benefit to patients with PsA treated in clinical practice.References:[1]Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Feb 10;75(3):499 LP-510[2]Torres T and Puig L. Apremilast: A novel oral treatment for psoriasis and psoriatic arthritis. Am J clin Dermatol. 2018 Feb;19(1):23-32[3]Coates LC, Kavanaugh A, Mease PJ et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015. Treatment Recommendations for Psoriatic Arthritis. Arthritis Rheumatol. 2016;68(5):1060– 71.Disclosure of Interests:Jordi Gratacos-Masmitja Speakers bureau: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., Consultant of: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., José Luis Álvarez Vega Speakers bureau: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Consultant of: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Grant/research support from: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Emma Beltrán Speakers bureau: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, ANA URRUTICOECHEA-ARANA: None declared., C. Fito-Manteca: None declared., Francisco Maceiras: None declared., Joaquin Maria Belzunegui Otano Speakers bureau: Lilly, Amgen, Novartis, Abbvie, Janssen., J. Fernández-Melón Speakers bureau: Amgen SL, Eugenio Chamizo Carmona: None declared., Abad Hernández Speakers bureau: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Consultant of: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Grant/research support from: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Inmaculada Ros Consultant of: Amgen, Grant/research support from: MSD, Roche, Novartis, lilly, Pfizer, Amgen, Eva Pascual Shareholder of: Amgen, Employee of: Amgen, Juan Carlos Torre Speakers bureau: Amgen, Lilly, Novartis, Janssen, Pfizer, Consultant of: Amgen, Lilly, Novartis, Janssen, Pfizer, Grant/research support from: Amgen, Lilly, Novartis, Janssen, Pfizer.


2021 ◽  
pp. jrheum.201627
Author(s):  
Rodrigo García Salinas ◽  
Einer Sanchez Prado ◽  
Santiago Ruta

Reported data of axial involvement in psoriatic arthritis (PsA) are variable (25–70%). This variability is mainly linked to different ways of defining this feature. Gladman1 established that the prevalence of axial involvement in PsA was close to 50% and that it is associated with HLA-B27. Likewise, psoriasis (PsO) spondylitis, unlike ankylosing spondylitis (AS), is characterized by not having a greater preponderance of the male sex, greater skin involvement, and a less severe course.2


2021 ◽  
pp. jrheum.201675
Author(s):  
William Tillett ◽  
Oliver FitzGerald ◽  
Laura C. Coates ◽  
Jon Packham ◽  
Deepak R. Jadon ◽  
...  

Objective To test shortened versions of the psoriatic arthritis (PsA) composite measures for use in routine clinical practice. Methods Clinical and patient-reported outcome measures (PROMs) were assessed in patients with PsA at 3 consecutive follow-up visits in a UK multicenter observational study. Shortened versions of the Composite Psoriatic Arthritis Disease Activity Index (CPDAI) and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Exercise (GRACE) measures were developed using PROMs and tested against the Disease Activity Score in 28 joints (DAS28), composite Disease Activity in Psoriatic Arthritis, and Routine Assessment of Patient Index Data (RAPID3). Discrimination between disease states and responsiveness were tested with the t-score, standardized response mean (SRM), and effect size (ES). Data were presented to members at the GRAPPA 2020 annual meeting and members voted on the recommended composite routine practice. Results The SRM for the GRACE, 3 visual analog scale (VAS), and 4VAS were 0.67, 0.77, and 0.63, respectively, and for CPDAI and shortened CPDAI (sCPDAI) were 0.54 and 0.55, respectively. Shortened versions of the GRACE increased the t-score from 7.8 to 8.7 (3VAS) and 9.0 (4VAS), but reduced the t-score in the CPDAI/sCPDAI from 6.8 and 6.1. The 3VAS and 4VAS had superior performance characteristics to the sCPDAI, DAS28, Disease Activity in Psoriatic Arthritis, and RAPID3 in all tests. Of the members, 60% agreed that the VAS scales contained enough information to assess disease and response to treatment, 53% recommended the 4VAS for use in routine care, and 26% the 3VAS, while leaving 21% undecided. Conclusion Shortening the GRACE to VAS scores alone enhances the ability to detect status and responsiveness and has the best performance characteristics of the tested composite measures. GRAPPA members recommend further testing of the 3VAS and 4VAS in observational and trial datasets.


Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Harikrishnan Pillai ◽  
Nilesh Nolkha ◽  
Augustus Yau ◽  
Susan Matthews ◽  
Alison Hall ◽  
...  

Abstract Background There is growing evidence for tapering biologic therapies in patients with rheumatoid arthritis in sustained clinical remission to avoid overtreatment and minimise side-effects. Ultrasound assessment for subclinical synovitis adds to clinical assessment of patients with rheumatoid arthritis suitable for tapering biologic therapies. Our primary objective was to combine clinical and ultrasound assessment to select patients with rheumatoid arthritis for tapering biologic therapies in routine clinical practice. The secondary objectives were to identify predictors for successful tapering and assess the cost savings to the local health economy by optimising the use of high cost drugs. Methods All patients with rheumatoid arthritis on a biologic therapy for 2 years and in sustained clinical remission (DAS28≤2.6) over the previous year were seen in the remission clinic. They had an Ultrasound scan of the small joints of the hands, wrists and other symptomatic joints. Patients with no activity on Power Doppler were advised to lengthen the interval of their biologic therapy gradually and were followed once every 3 months. Patients were not on oral steroids but continued conventional DMARDs. Patients had a dedicated helpline if they had a flare. Results Ninety-three of the 120 patients with rheumatoid arthritis on biologic therapy seen in the biologic remission clinic between January and October 2019 were eligible and all but one agreed to taper. They were 70% female with a mean age of 62.8 years and mean duration of disease 14.6 years. Their mean duration of biologic therapy was 6.3 years; mean baseline DAS28 was 6.3 pre-biologic therapy and 1.7 before tapering. Fifty-seven of the patients were on a TNF inhibitor and 35 were on other biologic therapies. Forty of the ninety-two patients were co-prescribed DMARDs. Screening failure was due to clinical activity in 13 patients, Ultrasound Power Doppler activity in 23 patients, interstitial lung disease in 2 patients and shoulder surgery in one. Only two of the 40 patients who had completed 6 months had a flare and reverted to the baseline frequency. Of the remaining 52 patients, 22 patients had completed 3 months at the tapered dose and 3 patients who were in the initial 3 months had a flare and reverted to the baseline frequency. Initial drug-cost savings at 6 months was approximately £45,000. Conclusion Tapering of biologic therapies in patients with rheumatoid arthritis is feasible in routine clinical practice. Ultrasound is helpful to stratify patients for biologic tapering and has enabled a higher proportion of patients to remain in remission after tapering. Disclosures H. Pillai: None. N. Nolkha: None. A. Yau: None. S. Matthews: None. A. Hall: None. G. Hirsch: None. S. Venkatachalam: None.


Rheumatology ◽  
2019 ◽  
Vol 58 (12) ◽  
pp. 2330-2331 ◽  
Author(s):  
Michelle L M Mulder ◽  
Alfons A den Broeder ◽  
Berbke T J van Ginneken ◽  
Elien A M Mahler ◽  
Frank H J van den Hoogen ◽  
...  

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e000928 ◽  
Author(s):  
Dafna Gladman ◽  
Peter Nash ◽  
Hitoshi Goto ◽  
Julie A Birt ◽  
Chen-Yen Lin ◽  
...  

ObjectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).MethodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test–retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.ResultsTest–retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett’s conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12–24 weeks of treatment.ConclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.


2015 ◽  
Vol 75 (4) ◽  
pp. 640-643 ◽  
Author(s):  
Laura C Coates ◽  
Philip S Helliwell

Treating to target is becoming the standard of care in many medical specialities, including rheumatology. The Tight Control of Psoriatic Arthritis (TICOPA) trial has recently provided evidence of the benefit of treating to target in psoriatic arthritis (PsA), and the revised European League Against Rheumatism (EULAR) recommendations on the management of PsA suggest this approach. However, the question of the optimal measure to use and the practicalities of incorporating this into routine clinical practice remain problematic.


2019 ◽  
Vol 46 (7) ◽  
pp. 710-715 ◽  
Author(s):  
Ruben Queiro ◽  
Juan D. Cañete ◽  
Carlos Montilla ◽  
Miguel Angel Abad ◽  
María Montoro ◽  
...  

Objective.To examine the grade of agreement between very low disease activity (VLDA) and Disease Activity Index for Psoriatic Arthritis (DAPSA) remission, as well as their association with the effect of the disease as assessed by the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire in patients with psoriatic arthritis in routine clinical practice.Methods.Posthoc analysis of data from a cross-sectional multicenter study. Patients were included who fulfilled the Classification for Psoriatic Arthritis (CASPAR) criteria with at least 1 year of disease duration and were treated with biological and/or conventional synthetic disease-modifying antirheumatic drugs according to routine clinical practice in Spain. Patients were considered in VLDA if they met 7/7 of the minimal disease activity criteria. DAPSA and clinical (c)DAPSA score ≤ 4 identified remissions.Results.Of the 227 patients included in the original study, 26 (11.5%), 52 (22.9%), and 65 (28.6%) were in VLDA, DAPSA remission, and cDAPSA remission, respectively. There was a moderate agreement between VLDA and DAPSA remission (κ = 0.52) or cDAPSA remission (κ = 0.42). Patients with VLDA had less effect of the disease as measured by PsAID [mean total score (SD): VLDA 1.1 (1.2); DAPSA remission 1.3 (1.5); cDAPSA remission 1.7 (1.6)]. There was a moderate agreement between DAPSA remission or cDAPSA remission and PsAID < 4 (κ = 0.46 and κ = 0.58 respectively), while poor agreement (κ = 0.18) was found between VLDA and PsAID < 4.Conclusion.VLDA criteria seem to be more stringent for assessing a status of remission; however, DAPSA remission shows better correlation with a patient-acceptable symptoms state than VLDA does.


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