PMS2 Patient-Reported Outcomes in Rheumatoid Arthritis Patients Treated with Tofacitinib or Biological Dmards in Real Life Conditions: Colombian and Peru Perspective

2021 ◽  
Vol 24 ◽  
pp. S138
Author(s):  
H. Madariaga ◽  
Sanchez JM Reyes ◽  
Ardila M Gutierrez ◽  
de Leon D Ponce ◽  
T. Lukic ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Real Life ◽  
Biological Dmards ◽  
Life Conditions ◽  
Patient Reported

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

scholarly journals SAT0121 PAIN AND OTHER PATIENT-REPORTED OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO DID OR DID NOT ACHIEVE TREATMENT RESPONSE BASED ON IMPROVEMENT IN SWOLLEN JOINTS IN TOCILIZUMAB CLINICAL TRIALS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 994.2-995
Author(s):  
A. Sebba ◽  
J. Han ◽  
S. Mohan
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Pain Score ◽  
Patient Reported Outcomes ◽  
Component Score ◽  
Link Type ◽  
Pain Scores ◽  
Sf 36 ◽  
Patient Reported ◽  
Nonresponder Group

Background:Significant improvements in pain and other patient-reported outcomes (PROs) have been shown in large clinical trials in patients with rheumatoid arthritis (RA) who receive tocilizumab (TCZ) compared with placebo (PBO). Recent data suggest that pain in RA may be noninflammatory as well as inflammatory, and improvement in pain scores and other PROs may be seen in patients who do not respond to treatment based on disease activity measures that evaluate inflammation.Objectives:To assess changes in pain scores and other PROs in patients with RA who did or did not achieve ≥ 20% improvement in SJC in TCZ clinical trials.Methods:Data from patients with active RA who received intravenous TCZ 8 mg/kg + MTX or PBO + MTX in 3 Phase III studies (OPTION [NCT00106548], TOWARD [NCT00106574] and LITHE [NCT00109408]) were included. All patients had moderate to severe RA with an inadequate response or intolerance of MTX (OPTION, LITHE) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TOWARD). Changes in pain (visual analog scale [VAS], 0-100 mm), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3), 36-Item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS; 0-50) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (0-52) from baseline to Week 24 were evaluated. Results were compared between patients receiving TCZ + MTX and those receiving PBO + MTX in both patients who achieved ≥ 20% improvement in SJC (responders) and those who did not (nonresponders). The changes from baseline were analyzed using a mixed model with repeated measures, including the following covariates and interactions: treatment, visit, baseline of endpoint, region, baseline DAS28 and interactions of visit with treatment and baseline of endpoint.Results:Data from 1254 responders (TCZ + MTX, n = 831; PBO + MTX, n = 423) and 620 nonresponders (TCZ + MTX, n = 225; PBO + MTX, n = 395) were included. Patients receiving TCZ + MTX had significantly greater improvement in pain scores and HAQ-DI compared with PBO + MTX in the responder group (–27.19 vs –16.77 and –0.55 vs –0.34, respectively;P< 0.0001 for both) and nonresponder group (–9.59 vs 2.53 and –0.20 vs 0.01;P< 0.0001 for both) at Week 24 (Figure 1). Similar results were seen at Week 16 in the nonresponder group (–11.06 vs –2.38 and –0.23 vs –0.04;P< 0.0001 for both) prior to initiation of rescue treatment. At Week 24 in the responder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS and MCS (9.16 vs 5.71 and 6.55 vs 3.79, respectively;P< 0.0001 for both) (Figure 2) and FACIT-Fatigue (8.39 vs 5.11;P< 0.0001). In the nonresponder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS at Week 16 (3.81 vs 1.65;P= 0.0006) and Week 24 (4.42 vs 1.01;P< 0.0001) (Figure 2) and FACIT-Fatigue at Week 16 (3.82 vs 1.32;P= 0.0039) and Week 24 (3.90 vs 1.40;P= 0.0111).Conclusion:Patients with RA who received TCZ + MTX had significantly greater improvements in pain score and other PROs than those who received PBO + MTX regardless of whether they achieved ≥ 20% improvement in SJC. Clinical outcome at Week 24 correlated well with PROs, with a relatively larger improvement in pain score and other PROs in the responder group than in the nonresponder group; relative to PBO + MTX, these improvements appear numerically similar in the responder and nonresponder groups with consistently smaller difference between the groups in TCZ-treated arms. The consistent effect of TCZ on PROs in both responder and nonresponder groups warrants further study on the impact of TCZ on sources of pain independent of that caused by joint inflammation.Figure:Acknowledgments:This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests:Anthony Sebba Consultant of: Genentech, Gilead, Lilly, Regeneron Pharmaceuticals Inc., Sanofi, Speakers bureau: Lilly, Roche, Sanofi, Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Shalini Mohan Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.

scholarly journals PATIENT-REPORTED OUTCOMES AMONG TREATED RHEUMATOID ARTHRITIS PATIENTS

2016 ◽  
Vol 19 (3) ◽  
pp. A237
Author(s):  
B.A. Feinberg ◽  
T. Olson ◽  
R.A. Burruss ◽  
D.F. Garofalo
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Patient Reported

scholarly journals Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience

2021 ◽  
Vol 10 (9) ◽  
pp. 1852
Author(s):  
Gry Assam Taarnhøj ◽  
Henriette Lindberg ◽  
Christoffer Johansen ◽  
Helle Pappot
Keyword(s):  
Quality Of Life ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Life Experience ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Real Life ◽  
Oncological Treatment ◽  
Patient Reported

Patients with urothelial cell carcinoma (UCC) often have comorbidities, which cause trouble for the completion of oncological treatment, and little is known about their quality of life (QoL). The aim of the present study was to obtain and describe patient-reported outcomes (PRO) and QoL data from UCC patients in the treatment for locally advanced muscle-invasive or metastatic UCC. A total of 79 patients with UCC completed four questionnaires (EORTC QLQ-C30, QLQ-BLM30, HADS, and select PRO-CTCAE™ questions) once weekly during their treatment. From those, 26 patients (33%) underwent neoadjuvant treatment for local disease while 53 patients (67%) were treated for metastatic disease. Of all patients, 54% did not complete the planned treatment due to progression, nephrotoxicity, death, or intolerable symptoms during treatment. The five most prevalent PRO-CTCAE grade ≥ 2 symptoms were frequent urination (37%), fatigue (35%), pain (31%), dry mouth (23%), and swelling of the arms or legs (23%). The baseline mean overall QoL was 61 (±SD 24) for all patients (neoadjuvant (73, ±SD 19) and metastatic (54, ±SD 24)) and remained stable over the course of treatment for both groups. A stable overall QoL was observed for the patients in this study. More than half of the patients did not, however, complete the planned treatment. Further supportive care is warranted for bladder cancer patients.

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