Objective.To assess longterm effectiveness of tumor necrosis factor inhibitors (TNFi) in patients with psoriatic arthritis (PsA) registered in the Rheumatic Diseases Portuguese Register, exposed to at least 1 TNFi, prospectively followed between 2001 and 2017.Methods.Kaplan-Meier analysis was performed for first-, second-, and third-line TNFi. Responses included European League Against Rheumatism (EULAR) criteria, Disease Activity Index for Psoriatic Arthritis (DAPSA), minimal disease activity (MDA), and Ankylosing Spondylitis Disease Activity Score (ASDAS) at 3 and 6 months. Baseline predictors of discontinuation and response were studied using Cox and multivariable multinomial/logistic regression models.Results.The 750 patients with PsA showed drug retention of 4.1 ± 3.4 years (followup 5.8 ± 3.8 yrs) for first TNFi. Switching to a second (189 patients) or third (50 patients) TNFi further decreased survival by 1.1 years. Female sex, higher baseline 28-joint count Disease Activity Score, and infliximab were predictors of first TNFi discontinuation. After 6 months of the first TNFi, 48.7% of patients achieved a good EULAR criteria response and 20.9% were in DAPSA remission. There were 11.4% in MDA, and 56.4% had a good ASDAS. Responses to the second TNFi were significantly inferior compared to responses to the first TNFi. Female sex and higher baseline Health Assessment Questionnaire–Disability Index were negatively associated with good EULAR response at 3 months, and obesity decreased the chance of response at 6 months.Conclusion.In this study, switching to a second or third TNFi was associated with significantly lower drug survival and response rates for patients with axial and peripheral PsA subtypes. More successful therapeutic approaches will require considering the effect of sex and obesity on TNFi effectiveness.
The aim of this paper was to assess the validity and reliability of the touch-screen standard Portuguese version of the following patient-reported outcomes (PROs), compared with paper format, in patients with rheumatoid arthritis (RA) and spondyloarthritis: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life scale (ASQoL), Short-Form 36 (SF-36), Health Assessment Questionnaire (HAQ) and visual analogue scales (VAS) measuring pain and burden of disease. Adult patients with RA and spondyloarthritis attending the Portuguese Institute of Rheumatology were recruited from March 2013 to January 2014. Patients filled the paper and touch-screen formats of the standard Portuguese versions of the PROs. Two groups of VAS were used, RA and psoriatic arthritis (Global VAS) and another specific for spondyloarthrites (Spa-VAS). Paper questionnaires were filled 15 min before touch-screen formats. Agreement between formats (validity) was assessed by intraclass correlation coefficient (ICC), while internal consistency of scales (reliability) was assessed by Cronbach's alpha. Overall, 134 patients were included with a mean age of 51 years, 74.6 % female and 57.5 % presenting RA. BASDAI, BASFI, HAQ and ASQoL showed high ICC between paper and touch-screen formats (0.977, 0.958, 0.974 and 0.940, respectively). ICC for Global VAS ranged from 0.906 to 0.921, while Spa-VAS ranged from 0.867 to 0.943. The mean ICC for all SF-36 domains was 0.889 (ICC for each domain ranged from 0.781 to 0.944). Touch-screen standard Portuguese formats of these PROs may be valid and reliable tools for PRO measurement in rheumatology.
Objectives. To compare the effectiveness of TNF inhibitors (TNFi) and tocilizumab in rheumatoid arthritis (RA) treatment, according to different response criteria. Methods. We included RA patients registered in the Rheumatic Diseases Portuguese Register treated with TNFi or tocilizumab for at least 6 months, between January 2008 and July 2013. We assessed remission/low disease activity (LDA) at 6 months according to DAS28, CDAI, and SDAI, as well as Boolean ACR/EULAR remission and EULAR response rate, adjusting for measured confounders. Results. Tocilizumab-treated patients (n = 95) presented higher baseline disease activity and were less frequently naïve to biologics compared to TNFi users (n = 429). Multivariate logistic regression analysis including the propensity score for receiving tocilizumab showed that patients treated with tocilizumab were more likely to achieve remission or LDA according to DAS28 (OR = 11.0/6.2, 95% CI 5.6–21.6/3.2–12.0), CDAI (OR = 2.8/2.6, 95% CI 1.2–6.5/1.3–5.5), or SDAI (OR = 3.6/2.5, 95% CI 1.5–8.7/1.1–5.5), as well as a good EULAR response (OR = 6.4, 95% CI 3.4–12.0). However, both groups did not differ in Boolean remission (OR = 1.9, 95% CI 0.8–4.8) or good/moderate EULAR response (OR = 1.8, 95% CI 0.8–4.5). Conclusions. Compared with TNFi, tocilizumab was associated with greater likelihood of achieving DAS28, CDAI, and SDAI remission/LDA and EULAR good response. Boolean remission and EULAR good/moderate response did not differ significantly between groups.
To evaluate a standardised enthesis ultrasound training method, a workshop was conducted to train rheumatologists on enthesis ultrasound. After a theoretical session about ultrasound elementary enthesis lesions (changes in tendon architecture/thickness, bone proliferation/erosion, bursitis or Doppler signal), a reading exercise of 28 entheses' ultrasonographic images (plantar fasciae, Achilles, origin and insertion of patellar tendon) was completed. Participants scored through an electronic multiple-choice device with six possible lesions in each enthesis. To assess the adequacy and efficacy of the workshop, we explored the following: (1) subjective outcomes: a 12-item structured satisfaction questionnaire (graded 1-5 using Likert scale) and (2) objective outcomes of reliability: sensitivity (Se), specificity (Sp) and percentage of correctly classified cases (CC). Forty-nine participants attended the workshop. The satisfaction questionnaire demonstrated a 4.7 mean global value. The inter-reader Kappa reliability coefficient was moderate for the plantar fascia (0.47), Achilles tendon (0.47), and distal patellar tendons (0.50) and good for the proximal patellar tendon (0.63). The whole group means comparing to teachers' consensus were as follows: (a) plantar fascia: Se, 73.2%; Sp, 87.7%; CC, 83.3%; (b) Achilles: Se, 66.9%; Sp, 85.0%; CC, 79.5%; (c) distal patellar tendon: Se, 74.6%; Sp, 85.3%; CC, 82.1%; and (d) proximal patellar tendon: Se, 82.2%; Sp, 90.6%; CC, 88%. The proposed learning method seemed to be simple, easily performed, effective and well accepted by the target audience.
Background:The impact of gender on tumor necrosis factor inhibitors (TNFi) effectiveness has been poorly studied in Psoriatic Arthritis (PsA) patients.Objectives:To study gender differences in persistence and response of 1st TNFi in PsA patients.Methods:PsA patients prospectively followed at the Rheumatic Diseases Portuguese Registry (Reuma.pt), treated with a 1st TNFi, between 2001 and 2016. Drug retention assessed by Kaplan-Meier survival analysis and Cox models, adjusted for the year of starting a TNFi. Response rates measured by EULAR response, DAPSA remission, MDA and ASDAS response, applying LUNDEX method, were compared between genders. Baseline predictors of discontinuation and response were identified (Cox and logistic regression models).Results:750 PsA patients, mean age 47.6 (± 11.6) years and 50.3% (n=377) females. PsA females showed significantly different baseline PsA disease characteristics in comparison with males and had more severe peripheral disease activity (Table 1). The overall TNFi survival rate for females was also significantly lower when compared with males (Figure 1). Additionally, females experienced lower rates of response at 3 and 6 months (Figure 2). Female gender was further identified as an independent predictor factor of worse persistence and showed a lower chance of good EULAR response.Conclusion:PsA females from Reuma.pt have distinct PsA features and worse persistence and response to a 1st TNFi in comparison with males. This might be related to gender dependent inflammatory pathways and was independent of baseline disease activity.Table 1Baseline characteristics of PsA patients from Reuma.pt, treated with a 1st TNFi, according to gender.CharacteristicsPopulation (n=750)Female (n=377)Male (n=373)p-valueAge at 1st TNFi, years (mean ± sd)47.6 ± 11.648.5 ± 11.746.7 ± 11.50.030†Obese (BMI>30Kg/m2), n (%)104 (25.2%)64 (30.9%)40 (19.5%)0.008†Clinical subtype, n (%),Symmetric polyarthritis401 (60.6%)228 (68.9%)173 (52.3%)<0.001†Arthritis distal interphalangeal joins29 (4.4%)9 (2.7%)20 (6.0%)Asymmetric oligoarthritis95 (14.3%)49 (14.8%)46 (13.9%)Mutilating arthritis9 (1.4%)3 (0.9%)6 (1.8%)Predominant axial128 (19.3%)42 (12.7%)86 (26.0%)Years since diagnoses until 1st TNFi (mean ± sd)6.6 ± 6.87.1 ± 7.06.0 ± 6.60.033†Swollen joints (mean ± sd)5.3 ± 5.56.2 ± 6.34.4 ± 4.4<0.001†Tender joints (mean ± sd)9.7 ± 9.611.9 ± 10.47.3 ± 8.1<0.001†ESR mm/1st h (mean ± sd)31.8 ± 25.335.8 ± 26.027.1 ± 23.8<0.001†MASES (mean + sd)2.0 ±3.23.0 ± 3.91.1 ± 2.1<0.001†DAS28 (mean + sd)4.9 ± 1.45.2 ± 1.34.5 ± 1.4<0.001†DAPSA (mean ± sd)29.9 ± 15.432.5 ± 16.526.7 ± 13.30.001†HAQ-DI (mean ± sd)1.13 ± 0.681.34 ± 0.660.90 ± 0.63<0.001†Concomitant csDMARDs, n (%)505 (67.6%)276 (73.6%)229 (61.6%)<0.001†Concomitant corticosteroids, n (%)253 (33.9%)157 (41.9%)96 (25.8%)<0.001†Figure 1First-line TNFi persistence of PsA patients from Reuma.pt, according to gender and adjusted for the year of staring a TNFi.Figure 2First-line TNFi LUNDEX-corrected responses of PsA patients from Reuma.pt, according to gender.Disclosure of ...
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