scholarly journals Patient-Reported Outcomes in RA Patients Treated With Tofacitinib or bDMARDs in Real-life Conditions in Two Latin American Countries

2021 ◽  
Author(s):  
JM Reyes ◽  
MV Gutierrez ◽  
H Madariaga ◽  
W Otero ◽  
R Guzman ◽  
...  
Keyword(s):  
Disease Activity ◽  
Latin American ◽  
Patient Reported Outcomes ◽  
Real Life ◽  
Clinical Information ◽  
Inadequate Response ◽  
Life Conditions ◽  
Patient Reported ◽  
The Mean ◽  
Noninterventional Study

Abstract Objective: To describe the efficacy, safety and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions.Methods: A noninterventional study was performed between March 2017 and September 2019 at 13 sites in Colombia and Peru. Demographic and clinical information was collected. Outcomes measured at baseline and at the 6-month follow-up were disease activity (RAPID3 [Routine Assessment of Patients Index Data] score), functional status (HAQ-DI [Health Assessment Questionnaire] score), and quality of life (EQ-5D-3L [EuroQol Questionnaire]). The Disease Activity Score-28 (DAS28-ESR) and frequency of adverse events (AEs) were also reported. Unadjusted and adjusted differences from baseline were estimated and expressed as the least squares mean difference (LMDs).Results: Data from 100 patients treated with tofacitinib and 70 patients with bDMARDs were collected. At baseline, the patients’ mean age was 53.53 years (SD 13.77), the mean disease duration was 6.31 years (SD 7.01) and the mean DAS28-ESR was 5.48 (SD 2.97). The change from baseline at month 6 was not statistically significant different in the adjusted LMD [SE] for tofacitinib vs. bDMARDs for RAPID3 score (-0.20 [0.69] vs. -0.32 [0.71]), HAQ-DI score (-0.56 [0.07] vs. -0.50 [0.08]), EQ-5D-3L score (0.23 [0.06] vs. 0.29 [0.06]) and DAS28-ESR (-3.86 [0.59] vs. -4.23 [0.61]). Patients from both groups presented similar proportions of nonserious and serious AEs. No deaths were reported. These results have noninterventional-study-specific limitations.Conclusion: Changes from baseline were not statistically significant different between tofacitinib and bDMARDs in terms of RAPID3 scores and the secondary outcomes (HAQ-DI score, EQ-5D-3L score and DAS28-ESR). Patients from both groups presented similar proportions of nonserious and serious AEs.Clinical trial number: NCT03073109

scholarly journals AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Real Life ◽  
Inadequate Response ◽  
Research Support ◽  
Das 28 ◽  
Patient Reported ◽  
One Year

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

Performance and psychometric properties of lupus impact tracker in assessing patient-reported outcomes in pediatric lupus: Report from a pilot study

Lupus ◽  
2020 ◽  
Vol 29 (13) ◽  
pp. 1781-1789
Author(s):  
Suhas K Ganguli ◽  
Joyce S Hui-Yuen ◽  
Meenakshi Jolly ◽  
Jane Cerise ◽  
Barbara Anne Eberhard
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Pilot Study ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Laboratory Data ◽  
Damage Index ◽  
Systemic Lupus ◽  
Patient Reported ◽  
The Mean

Objective To evaluate the reliability, validity, feasibility and psychometric performance of the Lupus Impact Tracker (LIT) as a patient reported outcome (PRO) measure tool in pediatric systemic lupus erythematosus (pSLE). Methods This is a prospective, observational, pilot study where patients aged between 12 and 25 years, fulfilling the 1997 ACR classification criteria for SLE, were enrolled. Over 3 consecutive, routine, clinical visits, the patients completed the LIT alongside the Patient-Reported Outcomes Measurement Information System-Short Forms (PROMIS-SFs), Childhood Health Assessment Questionnaire (CHAQ). Rheumatologists completed the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC-ACR) Damage Index. Demographic, clinical and laboratory data were also collected. Results Of 46 patients enrolled, 38 patients completed 2 visits and 31 completed all 3 visits. Seventy-eight percent were female, 33% African American, 28% Asian, 15% Caucasian and 17% Hispanic. The mean (SD) age was 17.2 (2.7) years, with a mean (SD) disease duration of 4.6 (3.1) years. The mean (SD) SLEDAI-2K at enrollment was 3.54 (2.96). In the 38 patients who completed two or more visits, intra-class correlation coefficient and Cronbach alpha were calculated to be 0.70 and 0.91 respectively, signifying good reliability of LIT. The LIT showed positive correlation with CHAQ-Disability Index and majority of the PROMIS-SFs parameters. Construct validity was established against clinical disease activity (SLEDAI-2K). Conclusion The preliminary results indicate that the LIT is a reliable and valid instrument to capture PRO in p-SLE. Prospective validation with a larger, multicenter cohort is the next step.

Changes in quality of life in relation to disease activity in systemic lupus erythematosus: post-hoc analysis of the BLISS-52 Trial

Lupus ◽  
2019 ◽  
Vol 28 (14) ◽  
pp. 1628-1639 ◽  
Author(s):  
M Jolly ◽  
N Annapureddy ◽  
L Arnaud ◽  
H Devilliers
Keyword(s):  
Disease Activity ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Sf 36 ◽  
Patient Reported ◽  
Outcome Scores ◽  
Activity Measures ◽  
Flare Index ◽  
The Mean

Objectives To quantify changes in generic patient-reported outcomes against clinically meaningful, disease activity measures in systemic lupus erythematosus (SLE). Methods Using BLISS-52 trial data (867 SLE patients), we estimated the mean difference in change of patient-reported outcome scores (Medical Outcomes Study SF-36 and FACIT-fatigue) in relation to disease activity (SELENA-SLEDAI, SELENA-SLEDAI flare index, SLE responder index and British Isles Lupus Assessment Group (BILAG)), considering all study visits by the mean of multivariate mixed models. Predefined disease activity criteria were used to define for improvement and worsening. Results Mean changes in physical component summary/mental component summary and FACIT-fatigue in response to changes in SELENA-SLEDAI and SELENA-SLEDAI flare index were significantly lower than 2.5. New SELENA-SLEDAI flare index flare led to a significant change in all patient-reported outcome scores, except role emotional. Mean improvement in patient-reported outcomes with achievement of SLE responder index ranged between +6.2 (physical function) and +11.3 (bodily pain) for SF-36 domains, + 3.4 and +3.3 for mental component summary and physical component summary, and was +4.2 for FACIT-fatigue. When considering disease activity changes by organ system, changes in BILAG (constitutional) was independently associated with significant changes in FACIT-fatigue and all SF-36 domains (except physical function), changes in BILAG (musculoskeletal and hematological) were independently associated with significant changes in patient-reported outcome scores, except for role emotional (musculoskeletal) and general health/mental health (hematological). Mean changes in every SF-36 domain varied (and was >5) with SLE responder index attainment. Conclusions Knowledge of changes in patient-reported outcomes, against clinically meaningful changes in SLE disease activity measures, is crucial for designing of clinical trials, interpretation of results and shared decision-making for patient care.

scholarly journals Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Vibeke Strand ◽  
Janet Pope ◽  
Namita Tundia ◽  
Alan Friedman ◽  
Heidi S. Camp ◽  
...  
Keyword(s):  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Normative Values ◽  
Number Needed To Treat ◽  
Inadequate Response ◽  
Mixed Effect ◽  
Meaningful Improvement ◽  
Sf 36 ◽  
Patient Reported

Abstract Background To evaluate the effect of upadacitinib on patient-reported outcomes (PROs) in patients with RA who had an inadequate response to csDMARDs. Methods Patients in SELECT-NEXT, a randomised controlled trial, were on a background of csDMARDs and received upadacitinib 15 mg and 30 mg or placebo daily for 12 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration and severity of morning (AM) joint stiffness, Short Form 36 Health Survey (SF-36), and Work Instability Scale for RA (RA-WIS). Least squares mean (LSM) changes were based on mixed-effect repeated measure models. Percentages of patients reporting improvements ≥ minimum clinically important differences (MCIDs) and scores ≥ normative values and number needed to treat (NNT) were determined; group comparisons used chi-square tests. Results Data from 661 patients were analysed. Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12. Significantly, more upadacitinib-treated patients (both doses, P < 0.05) reported improvements ≥ MCID in PtGA, pain, HAQ-DI, FACIT-F, AM stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores ≥ normative values in HAQ-DI, FACIT-F, and SF-36 (PCS and 4 or 5/8 domains). For most PROs, the incremental NNT with upadacitinib to report clinically meaningful improvement from baseline ranged from 4 to 8 patients. Conclusions Upadacitinib 15 mg or 30 mg daily for 12 weeks resulted in significant and clinically meaningful improvements in global disease activity, pain, physical function, fatigue, duration and severity of AM stiffness, HRQOL, and work instability among csDMARD-IR patients with RA. Trial registration Clinicaltrials.gov, NCT02675426. Retrospectively registered 5 February 2016.

scholarly journals POS0307 FATIGUE IN RHEUMATOID ARTHRITIS PATIENTS IS ASSOCIATED TO SUBJECTIVE BUT NOT OBJECTIVE ASSESSMENTS OF DISEASE ACTIVITY DURING TREATMENT WITH TOCILIZUMAB

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 379.1-380
Author(s):  
H. B. Hammer ◽  
B. Agular ◽  
L. Terslev
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Joint Pain ◽  
Patient Reported Outcomes ◽  
Clinical Laboratory ◽  
Inflammatory Activity ◽  
Inadequate Response ◽  
Open Label ◽  
Patient Reported

Background:Fatigue is common in patients with rheumatoid arthritis (RA), and its association with inflammatory activity is not fully understood.Objectives:To explore the associations between fatigue and inflammation by clinical, laboratory and ultrasound examinations during follow-up of RA patients on biological treatment.Methods:A Nordic (Denmark, Finland, Norway, Sweden) open-label, single-arm study (part of the umbrella program – TOZURA (1)), enrolled patients with inadequate response to conventional synthetic (cs) DMARDs. Patients received tocilizumab 162 mg sc weekly for 24 weeks as monotherapy or in combination with a csDMARD. Stable oral NSAIDs and corticosteroids (≤10 mg/day prednisone or equivalent), were allowed. Patients were assessed at baseline, 4, 12 and 24 weeks for fatigue (FACIT-F questionnaire (total sum scores)), patient reported outcome measures ((PROMs) including joint pain and patient’s global visual analogue scale (VAS) as well as HAQ-DI), clinical assessments (tender and swollen joints, assessor’s global VAS), laboratory examinations (ESR, CRP) and ultrasound assessments (36 joints and 4 tendons, scored according to the Norwegian US atlas (2)). Spearman correlations, performed both at baseline and for changes from baseline of variables during follow-up, explored associations between fatigue and PROMs, clinical, laboratory as well as ultrasound variables. Predictive value of fatigue was investigated by linear regression.Results:110 patients were included (83% female, mean (SD) age 55.6 (12.1) years and RA duration 8.7 (9.5) years, 81% anti-CCP positive). All PROMs, clinical, laboratory and ultrasound variables decreased significantly, already after 4 weeks (p<0.001). Both for baseline assessments as well as for changes during follow-up, fatigue was associated with PROMs (Table 1 (baseline) and Table 2 (follow-up)). However, there were no or low associations between fatigue and clinical, laboratory and ultrasound assessments at baseline or during follow-up. In addition, baseline fatigue was predictive of joint pain, patient’s global VAS and HAQ-DI during follow-up (p<0.05-0.001), but not for the clinical, laboratory or ultrasound assessments.Conclusion:Fatigue assessed by an established questionnaire did not show any associations with several assessments of inflammatory activity in RA patients, neither at baseline nor during effective treatment. Thus, the present study adds to the increasing number of papers finding fatigue to reflect other aspects of RA disease activity than inflammation.References:[1]Choy E et al. Rheumatology 2018; 2. Hammer HB et al, ARD 2011Table 1.Spearman correlations between FACIT-F total score and patient reported outcomes, clinical, laboratory and ultrasound assessments. *p<0.05. **p<0.001Table 2.Spearman correlations between changes in FACIT-F total score from baseline to 4, 12 and 24 weeks and changes in patient reported outcomes, clinical, laboratory and ultrasound assessments. *p<0.05. **p<0.001Disclosure of Interests:Hilde Berner Hammer Speakers bureau: AbbVie, Pfizer, Roche, Lilly and Novartis, Consultant of: Novartis, Birte Agular Employee of: Roche, Lene Terslev Speakers bureau: Roche, MSD, BMS, Pfizer, AbbVie, Novartis and Janssen

scholarly journals AB0188 DO PATIENT-REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS REFLECT DISEASE ACTIVITY?

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1118.2-1119
Author(s):  
K. Ben Abdelghani ◽  
H. Boussaa ◽  
S. Miladi ◽  
M. Sellami ◽  
L. Souabni ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Objective Assessment ◽  
Disease State ◽  
Spontaneous Pain ◽  
Patient Reported ◽  
The Mean ◽  
The Impact

Background:Patient-reported outcomes (PROs) reflect the patient’s perspective and are used in rheumatoid arthritis (RA) routine clinical practice. However, PROs may be associated with other aspects of health, such as psychological distress or comorbidities, which leads to situations of discordance with objective RA assessments.Objectives:The aim of this study was to determine whether PROs were associated with objective assessment of disease activity.Methods:We conducted a cross-sectional study including patients with RA (ACR/EULAR 2010). Demographic data were collected. The following PROs were assessed: number of nocturnal awakenings, morning stiffness duration, estimation of spontaneous pain and fatigue by Visual Analog Scale (VAS), and global patient assessment (GPA). In addition, patients rated their current satisfaction with their disease state according to the Austrian school mark system (PATSAT: 1=excellent, 2=good, 3=average, 4=moderate (fair), 5=unsatisfactory). Disease activity was assessed using the 28-joint disease activity score with erythrocyte sedimentation rate (DAS28 ESR) and C reactive protein (DAS28 CRP). We used Cohen’s kappa (κ) to determine the agreement between PATSAT and DAS28 ESR. The κ result was interpreted as follows: values ≤ 0 as indicating no agreement and 0.01–0.20 as none to slight, 0.21–0.40 as fair, 0.41– 0.60 as moderate, 0.61–0.80 as substantial, and 0.81–1.00 as almost perfect agreement. A p-value inferior to 0.05 was considered significant.Results:We included 54 patients (45 women and nine men) with a mean age of 55±11 years old [23-69]. The mean disease duration was 9.9±5.9 years [0-20]. The mean number of nocturnal awakenings was 1.1 [0-4] and the mean morning stiffness duration was 25.1 minutes [0-120]. The mean GPA was 5.3±2.2 cm [0-10]. The mean pain VAS was 5.4±2.2 cm [0-10] and the mean fatigue VAS was 4±2.5 cm [0-8]. None of the patients described his disease state as ‘excellent’. It was considered ‘good’ in 23.1% of cases, ‘average’ in 36.5% of cases, and ‘moderate’ to ‘unsatisfactory’ in 40.4% of cases.The mean ESR and CRP were 46.3±29.3 mm [5-120] and 15.8 mg/l [0.6-100] respectively. The mean DAS28 ESR was 4.68±1.35 [1.50-7.16] and the mean DAS28 CRP was 3.9±1.1 [1.02-6.05].A significant positive correlation was noted between both DAS28 ESR and DAS28 CRP and, number of nocturnal awakenings (r=0.385, p=0.013 and r=0.448, p=0.002), morning stiffness duration (r=0.495, p=0.001 and r=0.617, p<0.001), GPA (r=0.485, p<0.001 and r=0.530, p<0.001), and pain VAS (r=0.594, p<0.001 and r=0.598, p<0.001). No correlation was found between the two scores and fatigue VAS.No significant agreement was noted between PATSAT and DAS28 ESR (κ=0.077, p=0.478).Conclusion:PROs showed moderate to strong correlation with disease activity scores. The timely and effective use of PROs could encourage physicians to focus more on the impact of RA on patients and how patients are feeling. This in turn would facilitate shared decision making between patients and physicians.Disclosure of Interests:None declared

Sign in / Sign up

Export Citation Format

Share Document