scholarly journals Improvement in patient-reported outcomes after rituximab in rheumatoid arthritis patients: An open-label assessment of 175 patients

2015 ◽  
Vol 82 (6) ◽  
pp. 451-454 ◽  
Author(s):  
Laure Gossec ◽  
Agnès Danré ◽  
Bernard Combe ◽  
Xavier Le Loët ◽  
Jaques Tebib ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Open Label ◽  
Patient Reported

The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis

2016 ◽  
Vol 43 (7) ◽  
pp. 1268-1277 ◽  
Author(s):  
Piotr Wiland ◽  
Jean Dudler ◽  
Douglas Veale ◽  
Hasan Tahir ◽  
Ron Pedersen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Group Versus ◽  
Treatment Withdrawal ◽  
Joint Disease ◽  
Open Label ◽  
Double Blind ◽  
Link Type ◽  
Patient Reported

Objective.An analysis of a clinical trial to assess the effects of treatment reduction and withdrawal on patient-reported outcomes (PRO) in patients with early, moderate to severe rheumatoid arthritis (RA) who achieved 28-joint Disease Activity Score (DAS28) low disease activity (LDA) or remission with etanercept (ETN) plus methotrexate (MTX) therapy.Methods.During treatment induction, patients received open-label ETN 50 mg weekly plus MTX for 52 weeks. In the reduced-treatment phase, patients with DAS28-erythrocyte sedimentation rate (ESR) ≤ 3.2 at Week 39 and DAS28-ESR < 2.6 at Week 52 in the open-label phase were randomized to double-blind treatment with ETN 25 mg plus MTX, MTX, or placebo (PBO) for 39 weeks (weeks 0–39). In the third phase, patients who achieved DAS28 remission (DAS28-ESR < 2.6) or LDA (2.6 ≤ DAS28-ESR ≤ 3.2) at Week 39 in the double-blind phase had all treatment withdrawn and were observed for an additional 26 weeks (weeks 39–65).Results.Of the 306 patients enrolled, 193 were randomized in the double-blind phase and 131 participated in the treatment-withdrawal phase. After reduction or withdrawal of ETN 50 mg/MTX, patients reduced to ETN 25 mg/MTX experienced slight, nonsignificant declines in the majority of PRO measures, whereas switching to PBO or MTX alone caused significant declines. Presenteeism and activity impairment scores were significantly better in the ETN reduced-dose group versus MTX monotherapy and PBO at Week 39 (p ≤ 0.05).Conclusion.In patients with early RA who achieved remission while receiving full-dose ETN/MTX, continuing combination therapy at a lower dose did not cause a significant worsening of PRO response, but switching to MTX alone or PBO did.ClinicalTrials.govidentifier:NCT00913458.

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 Oxygen saturation improved with nitrate-based nutritional formula in patients with COVID-19

2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110123
Author(s):  
Sergej M. Ostojic ◽  
Aleksandra Milovancev ◽  
Patrik Drid ◽  
Alexandros Nikolaidis
Keyword(s):  
Oxygen Saturation ◽  
Patient Reported Outcomes ◽  
Case Series ◽  
Potassium Nitrate ◽  
Open Label ◽  
Patient Reported ◽  
Baseline Values ◽  
Study Participants ◽  
To Receive ◽  
Test Result

In this open-label case series trial, we evaluated the effects of a nitrate-based nutritional formula on oxygen saturation (SpO2) and patient-reported outcomes in individuals with coronavirus disease 2019 (COVID-19). Five adult patients (three men and two women, age 39.6 ± 6.9 years) with a positive COVID-19 test result, breathing difficulties, and SpO2 ≤95%, who were free from other pulmonary and cardiovascular conditions, were recruited for this study. Participants were assigned to receive a multi-component nutritional formula (containing 1200 mg of potassium nitrate, 200 mg of magnesium, 50 mg of zinc, and 1000 mg of citric acid) every 4 hours during the 48-hour monitoring period. In all participants, SpO2 improved immediately after administration of the nutritional formula, from 1 to 7 percentage points (mean increase 3.6 ± 2.7 points; 95% confidence interval 0.3 to 7.0). SpO2 remained above baseline values throughout the monitoring interval, with values persisting over threshold values (>92%) for all patients and at each time point during the 48 hours. No patients reported any side effects of the intervention. These promising and rather unexpected results call for immediate, well-sampled, mechanistic randomized controlled trials to validate our findings.

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 Efficacy and Safety of Adalimumab in Canadian Patients with Moderate to Severe Crohn’s Disease: Results of the Adalimumab in Canadian SubjeCts with ModErate to Severe Crohn’s DiseaSe (ACCESS) Trial

2011 ◽  
Vol 25 (8) ◽  
pp. 419-425 ◽  
Author(s):  
Remo Panaccione ◽  
Edward V Loftus ◽  
David Binion ◽  
Kevin McHugh ◽  
Shamsul Alam ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Patient Reported Outcomes ◽  
Activity Index ◽  
Work Productivity ◽  
Clinical Effectiveness ◽  
Open Label ◽  
Adalimumab Therapy ◽  
Patient Reported ◽  
Fistula Healing

OBJECTIVE: To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn’s disease (CD) who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF) therapy.METHODS: Patients with moderate to severe CD (CD activity index [CDAI] score of greater than 220, or Harvey-Bradshaw index [HBI] of 7 or greater) were eligible. Patients received open-label adalimumab as induction (160 mg and 80 mg subcutaneously [sc]) at weeks 0 and 2, respectively and maintenance (40 mg sc every other week) therapy. At or after eight weeks, patients with flare or nonresponse could have their dosage increased to 40 mg sc weekly. Patients were followed for a minimum of six months or until adalimumab was commercially available in Canada.RESULTS: Of the 304 patients enrolled, 160 were infliximab experienced, while 144 were anti-TNF naive. HBI remission (HBI score of 4 or lower) at week 24 was achieved by 53% of anti-TNF-naive and 36% of infliximab-experienced patients (P<0.01; P<0.001 for both groups for all visits versus baseline). Fistula healing rates at week 12 were 48% for anti-TNF-naive patients, and 26% for infliximab-experienced patients. At week 24, fistula healing rates were significantly greater for the anti-TNF-naive group (60% versus 28%; P<0.01). Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients. Serious infections occurred in 2% of patients.CONCLUSIONS: Adalimumab therapy induced and sustained steroid-free remission in both infliximab-experienced and anti-TNF-naive patients with moderate to severe CD. Clinically meaningful rates of fistula healing were also observed. Improvements in patient-reported outcomes were sustained throughout the 24-week study period.

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
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