scholarly journals Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Atul A. Deodhar ◽  
Philip J. Mease ◽  
Proton Rahman ◽  
Victoria Navarro-Compán ◽  
Vibeke Strand ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Sleep Quality ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Axial Spondyloarthritis ◽  
Spinal Pain ◽  
Additional Patient ◽  
Link Type ◽  
Patient Reported ◽  
Global Disease Activity

Abstract Background This analysis assessed improvements in patients with radiographic axial spondyloarthritis (r-axSpA) treated with ixekizumab in the Assessment of Spondyloarthritis International Society (ASAS) treatment response domains and additional patient-reported outcomes at 1 year of treatment. Methods COAST-V and COAST-W were 52-week, phase 3, randomized controlled trials evaluating the efficacy and safety of ixekizumab in biologic disease-modifying antirheumatic drug (bDMARD)-naïve and tumor necrosis factor inhibitor (TNFi)-experienced patients with radiographic spondyloarthritis, respectively. Patients were treated with 80-mg ixekizumab either every 2 weeks or every 4 weeks. Patient-reported outcomes included Patient Global Disease Activity, Spinal Pain, stiffness as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Questions 5 and 6, function as measured by the Bath Ankylosing Spondylitis Functional Index, fatigue as measured by the Fatigue Numeric Rating Scale and BASDAI question 1, Spinal Pain at Night, and sleep quality as measured by the Jenkins Sleep Evaluation Questionnaire. Mixed-effects models for repeated measures were used to analyze changes from baseline in patient-reported outcomes from weeks 1 to 16, and descriptive statistics were reported from weeks 20 to 52. Analysis of covariance with Scheffé’s method was used for the ASAS response association analyses. Results This study assessed 341 bDMARD-naïve and 316 TNFi-experienced patients in the placebo-controlled blinded treatment dosing period (weeks 1–16) as well as 329 bDMARD-naïve and 281 TNFi-experienced patients in the dose double-blind extended treatment period (weeks 20–52). bDMARD-naïve or TNFi-experienced patients treated with ixekizumab every 2 weeks and every 4 weeks reported improvements in patient global disease activity, spinal pain, function, stiffness, fatigue, spinal pain at night, and sleep quality through week 52. Greater correlations with improvements in all response domains were seen when comparing ASAS40 responders to ASAS20 non-responders (p < 0.001), with up to 10.5-fold greater improvements observed in ASAS40 responses compared with ASAS20 non-responders. Function and fatigue demonstrated the highest values. Conclusions Ixekizumab-treated bDMARD-naïve and TNFi-experienced patients with radiographic axial spondyloarthritis achieving ASAS40 reported sustained and consistent improvement in all ASAS response domains and other patient-reported outcomes though week 52, with spinal pain, function, and stiffness as major drivers of the response. Trial registration NCT02696785 and NCT02696798, March 2, 2016.

scholarly journals Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Maxime Dougados ◽  
Désirée van der Heijde ◽  
Wen-Chan Tsai ◽  
Diego Saaibi ◽  
Lisa Marshall ◽  
...  
Keyword(s):  
Back Pain ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Axial Spondyloarthritis ◽  
Analysis Of Covariance ◽  
General Fatigue ◽  
Composite Indices ◽  
Patient Reported ◽  
Very High

Abstract Background We assessed the external validity of composite indices Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Assessment in SpondyloArthritis international Society (ASAS) 40 response (ASAS40) by evaluating the correlations between the changes in some patient reported outcomes (PROs) for patients with non-radiographic axial spondyloarthritis (nr-axSpA) and the changes in the scores of the composite indices. Methods This was a post-hoc analysis of data from the EMBARK study in patients with nr-axSpA treated with etanercept. PROs were grouped according to ASDAS status (inactive [< 1.3], low [≥ 1.3 to < 2.1], high [≥ 2.1 to ≤3.5], and very high [> 3.5]), patient achievement of > 50% improvement in BASDAI (BASDAI50 responders), and > 40% improvement in ASAS (ASAS40 responders) at 104 weeks. Analyses were conducted on observed cases available at Week 104. Changes in PROs from Baseline to Week 104 were assessed using analysis of covariance with adjustment for baseline with linear contrast. Results Higher ASDAS disease activity at 104 weeks was associated with lower long-term improvement from baseline in PROs (e.g., total back pain [visual analog scale, cm (95% confidence interval): − 4.58 (− 4.95, − 4.21), − 3.86 (− 4.28, − 3.43), − 2.15 (− 2.68, − 1.61), and 1.30 (− 0.51, 3.12) for inactive, low, high, and very high ASDAS disease activity, respectively; Multidimensional Fatigue Inventory (MFI) general fatigue: − 4.77 (− 5.70, − 3.84), − 2.96 (− 4.04, − 1.87), − 1.00 (− 2.32, 0.31), and 2.14 (− 2.10, 6.38); all p < 0.001)]. BASDAI50 non-responders had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: − 1.61 (− 2.05, − 1.18) vs. –4.43 (− 4.69, − 4.18); MFI general fatigue: − 0.01 (− 1.12, 1.09) vs. –4.30 (− 4.98, − 3.62); all p < 0.001). ASAS40 non-responders also had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: − 1.91 (− 2.30, − 1.52) vs. –4.75 (− 5.05, − 4.46); MFI general fatigue: − 0.63 (− 1.56, 0.30) vs. –4.64 (− 5.37, − 3.91); all p < 0.001). Conclusion Composite indices are valid for monitoring treatment response and adequately reflect treatment-related changes experienced by patients with nr-axSpA. Trial registration ClinicalTrials.gov identifier: NCT01258738. Registered 9 December 2010.

Adalimumab Improves Sleep and Sleep Quality in Patients with Active Ankylosing Spondylitis

2010 ◽  
Vol 38 (1) ◽  
pp. 79-86 ◽  
Author(s):  
MARTIN RUDWALEIT ◽  
KATHERINE GOOCH ◽  
BEAT MICHEL ◽  
MANFRED HEROLD ◽  
ÅKE THÖRNER ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Sleep Quality ◽  
Disease Activity ◽  
Clinical Significance ◽  
Patient Reported Outcomes ◽  
Sleep Problems ◽  
Short Form ◽  
Effect Sizes ◽  
Period Effect ◽  
Patient Reported

Objective.Fatigue and sleep problems are significant in patients with ankylosing spondylitis (AS). This subanalysis of the RHAPSODY study (Review of Safety and Effectiveness with Adalimumab in Patients with Active Ankylosing Spondylitis) was conducted to evaluate the effect of adalimumab on sleep in patients with active AS.Methods.All patients (n = 1250) had active AS and received adalimumab 40 mg every other week during the 12-week open-label treatment period. Sleep was assessed by the Medical Outcomes Study Sleep Scale (MOS-SS) at screening and Weeks 6, 12, and 20 (optional continuation period). Effect sizes were calculated to determine clinical significance. Paired Student t tests compared the change in the MOS-SS domains from Week 12 to baseline. Correlation coefficients were calculated to determine the relationship between change in sleep domains and other Week 12 clinical and patient-reported outcomes (Bath AS Disease Activity Index, C-reactive protein, nocturnal pain, total back pain, Bath AS Functional Index, patient’s global assessment of disease activity, morning stiffness, Short Form-36 Health Survey, and Work Productivity and Activity Impairment questionnaire components).Results.At Week 12, adalimumab significantly improved sleep in each of the MOS-SS domains (p < 0.001). Effect sizes for 3 of the 6 domains (disturbance, −0.69; adequacy, 0.55; somnolence, −0.52) and both sleep problems indices (Index I, −0.68; Index II, −0.77) were moderate, suggesting clinical significance. Change in the MOS-SS Sleep Problem Index II was moderately correlated with change in most clinical and patient-reported outcomes. Sleep improvements were similar in patients with and without radiographically advanced AS.Conclusion.Adalimumab improves overall sleep and sleep quality in patients with active AS.

scholarly journals SAT0611-HPR LOW ADHERENCE TO RECOMMENDED PHYSICAL THERAPY IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: A MIXED-METHOD CONTENT AND UTILIZATION ANALYSIS.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1266.2-1266
Author(s):  
E. Vanautgaerden ◽  
M. Kaerts ◽  
W. Dankaerts ◽  
K. De Vlam ◽  
T. Swinnen
Keyword(s):  
Physical Therapy ◽  
Disease Activity ◽  
Mixed Method ◽  
Axial Spondyloarthritis ◽  
Physical Therapists ◽  
Skills Training ◽  
Treatment Modalities ◽  
Patient Reported ◽  
Global Disease Activity ◽  
Therapy Sessions

Background:Patients with axial spondyloarthritis (axSpA) encounter limitations during daily activities and societal participation which seriously impart health-related quality of life. Optimal management of axSpA consists of combined pharmacological and non-pharmacological treatment modalities, including the encouragement of exercise and the consideration of physical therapy given the latter’s superior efficacy1. Few studies investigated the use of physical therapy and the alignment of treatment content with practice recommendations among patients with axSpA.Objectives:1) To estimate physical therapy use in patients with axSpA in a real life cohort; 2) to quantitatively and qualitatively describe the content of these physical therapy sessions; 3) explore possible determinants of physical therapy use and content.Methods:This cross-sectional study included 197 patients diagnosed with axSpA (Males/Females: 62.4/37.6%; mean±SD, age 42.6±12.0, BASDAI 3.7±2.1, BASFI 3.6±2.4, BASMI 3.1±1.8) and recruited during their routine consultation. The mixed-method approach included questionnaires (physical therapy use and content, medication, depression/anxiety (HADS), fear (TSK), physician global disease activity (PGDA)) and an in-depth qualitative interview (content of physical therapy). Interviews were analyzed using the Qualitative Analysis Guide of Leuven by two physical therapists. Spearman’s Rho correlations guided the exploration of determinants of physical therapy use and content.Results:Less than half (42.6%, n=84) of the axSpA of patients were in treatment with a physiotherapist. Most patients (40.0%) reported a physical therapy frequency of 1x/week. Session duration was typically 30 minutes (51.7% of the sample) and longer in fewer cases (30.0%). Exercise was in only 31.7% the cornerstone of their sessions. The majority of subjects (53.3%) were classified as receiving ‘passive therapy only’, with 10% of cases in the ‘exercise only’ and 36.7% in the ‘combination therapy’ groups. Interviews also revealed a lack of clear patient-centered treatment goals. We found moderate associations between physical therapy use/content parameters and medication, spinal mobility, fear, anxiety, depression, physician’s global disease activity versus (p<.05), but no relationship with patient-reported pain or disease activity.Conclusion:Despite the importance of exercise and the added value of physical therapy in axSpA, few patients engaged in physical therapy sessions that include exercise training of adequate dosage. Remarkably, physical therapy utilization seems to be predominantly guided by psychological factors. Professional education for physical therapists should therefore include skills training in the management of complex clinical presentations2. Last, future research should prepare the evidence-based implementation of state-of-the-art physical therapy guidelines in axSpA.References:[1]van der Heijde D, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jun;76(6):978-991.[2]Swinnen TW, et al. Widespread pain in axial spondyloarthritis: clinical importance and gender differences. Arthritis Res Ther. 2018 Jul 27;20(1):156.Disclosure of Interests:Evelyne Vanautgaerden: None declared, Marlies Kaerts: None declared, Wim Dankaerts: None declared, Kurt de Vlam Grant/research support from: Celgene, Eli Lilly, Pfizer Inc, Consultant of: AbbVie, Eli Lilly, Galapagos, Johnson & Johnson, Novartis, Pfizer Inc, UCB, Thijs Swinnen: None declared

scholarly journals POS0919 BIMEKIZUMAB SHOWS SUSTAINED LONG-TERM IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AND QUALITY OF LIFE IN ANKYLOSING SPONDYLITIS: 3-YEAR RESULTS FROM A PHASE 2B STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 720.2-721
Author(s):  
X. Baraliakos ◽  
M. Dougados ◽  
K. Gaffney ◽  
R. Sengupta ◽  
M. Magrey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Spinal Pain ◽  
Research Support ◽  
Sf 36 ◽  
Patient Reported ◽  
Full Analysis

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, has demonstrated clinical efficacy and safety in patients with ankylosing spondylitis (AS) treated over a period up to 96 weeks.1,2Objectives:To report 3-year interim patient-reported outcomes (PROs) in patients with active AS treated with BKZ in a phase 2b dose-ranging study (BE AGILE; NCT02963506) and its open-label extension (OLE; NCT03355573).Methods:BE AGILE study design has been described previously.1 Patients treated with BKZ 160 mg or 320 mg every 4 weeks (Q4W) at Week 48 in BE AGILE were eligible for OLE entry. All OLE patients received BKZ 160 mg Q4W. Outcome measures are reported for the OLE full analysis set (patients who entered the OLE and had ≥1 dose of BKZ and ≥1 valid efficacy variable measurement in the OLE), and include: BASDAI, BASDAI50 responder rate, BASFI, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), total spinal pain (numeric rating scale [NRS]), SF-36 PCS and MCS, and ASQoL. Missing data were imputed using multiple imputation (MI; based on the missing at random assumption) for continuous variables and non-responder imputation (NRI) for dichotomous variables.Results:262/303 (86%) patients randomised at BE AGILE study baseline (BL) completed Week 48 on BKZ 160 mg or 320 mg, of whom 255/262 (97%) entered the OLE (full analysis set: 254). From baseline to Week 48 in BE AGILE, BKZ-treated patients showed clinically relevant improvements in disease activity (BASDAI, BASDAI50), physical function (BASFI), fatigue, morning stiffness, spinal pain, and quality of life (SF-36 PCS and MCS, ASQoL) (Figure 1). Group-level improvements in all reported continuous efficacy measures exceeded published minimally important difference (MID), minimum clinically important improvement (MCII), and/or minimum clinically important difference (MCID) thresholds (Figure 1).3,4 Efficacy in all reported outcome measures was maintained or continued to improve from Week 48 to Week 144 or 156 (Figure 1).Conclusion:BKZ treatment was associated with sustained and consistent efficacy in patients with active AS over 3 years, including patient-reported disease activity, physical function, fatigue, morning stiffness, spinal pain, and quality of life.References:[1]van der Heijde D. Ann Rheum Dis 2020;79:595–604.[2]Baraliakos X. Arthritis Rheumatol 2020;72 (suppl 10).[3]Ogdie A. Arthritis Care Res 2020;72 (S10):47–71.[4]Maruish ME. User’s manual for the SF-36v2 Health Survey (3rd ed). 2011; Lincoln, RI: QualityMetric Incorporated.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Karl Gaffney Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Eli Lilly, Novartis, UCB Pharma, Grant/research support from: AbbVie, Gilead, Eli Lilly, Novartis, UCB Pharma, Raj Sengupta Speakers bureau: AbbVie, Biogen, Celgene, MSD, Novartis, UCB Pharma, Consultant of: AbbVie, Biogen, Celgene, Eli Lilly, MSD, Novartis, UCB Pharma, Grant/research support from: AbbVie, Celgene, UCB Pharma, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Valerie Ciaravino Employee of: UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB Pharma

scholarly journals The Sex Influence on Response to Tumor Necrosis Factor-α Inhibitors and Remission in Axial Spondyloarthritis

2017 ◽  
Vol 45 (2) ◽  
pp. 195-201 ◽  
Author(s):  
Ennio Lubrano ◽  
Fabio Massimo Perrotta ◽  
Maria Manara ◽  
Salvatore D’Angelo ◽  
Olga Addimanda ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Response To Treatment ◽  
Inactive Disease ◽  
Disease Remission ◽  
Female Patients ◽  
Patient Reported ◽  
Factor Α ◽  
Necrosis Factor

Objective.The aim of this study was to evaluate the influence of sex on response to treatment and disease remission in patients with axial spondyloarthritis (axSpA).Methods.In this retrospective multicenter study, patients with axSpA, according to the Assessment of Spondyloarthritis international Society (ASAS) criteria for axSpA, and treated with adalimumab, etanercept, golimumab, or infliximab, were studied. We compared clinical characteristics, patient-reported outcomes, disease activity, function, and response to treatment in male and female patients with this disease.Results.Three hundred forty patients with axSpA (270 with ankylosing spondylitis, 19 with psoriatic arthritis with axial involvement, and 51 with nonradiographic axSpA) were studied. Male subjects had a significantly higher prevalence of grade IV sacroiliitis, higher levels of serum C-reactive protein, lower Maastricht Ankylosing Spondylitis Enthesitis Score, and fatigue when compared with females. Further, Kaplan-Meier survival curves showed that the rate of partial remission, ASAS40 response, and Ankylosing Spondylitis Disease Activity Score (ASDAS) major improvement, but not ASDAS inactive disease, were significantly lower in female patients.Conclusion.Our data suggest that female sex was associated with a lower rate of response to treatment and of disease remission in patients with axSpA treated with antitumor necrosis factor-α drugs.

Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1)

2016 ◽  
Vol 76 (1) ◽  
pp. 203-207 ◽  
Author(s):  
Vibeke Strand ◽  
Philip Mease ◽  
Laure Gossec ◽  
Ori Elkayam ◽  
Filip van den Bosch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Life Quality ◽  
Phase Iii ◽  
Patient Reported ◽  
Related Quality ◽  
Global Disease Activity

ObjectiveTo evaluate the effect of secukinumab on patient-reported outcomes (PROs) in subjects with active psoriatic arthritis (PsA) in the FUTURE 1 study.MethodsSubjects were randomised 1:1:1 to receive intravenous (i.v.) secukinumab 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous secukinumab 150 or 75 mg every 4 weeks or matching placebo until week 24.ResultsAt week 24, subjects receiving secukinumab i.v.→150 mg or i.v.→75 mg reported greater least squares mean changes from baseline than those receiving placebo in patient global assessment of disease activity (−20.6 and −20.0 vs −7.4, respectively), patient assessment of pain (−20.8 and −20.4 vs −6.7), psoriatic arthritis quality of life (−3.5 and −3.2 vs −0.4), Dermatology Life Quality Index (−8.8 and −7.9 vs 0.7); p<0.0001 vs placebo for both secukinumab groups for above PROs and Functional Assessment of Chronic Illness Therapy-Fatigue (6.74 (p<0.05 vs placebo) and 6.03 vs 4.00); all of which well exceeded minimum clinically important differences.ConclusionsIn subjects with PsA, secukinumab treatment resulted in clinically meaningful improvements in global disease activity, pain, generic and disease-specific measures of health-related quality of life and fatigue.Trial registration numberNCT01392326; Results.

Sleep Problems in Patients with Rheumatoid Arthritis

2013 ◽  
Vol 41 (1) ◽  
pp. 31-40 ◽  
Author(s):  
René Westhovens ◽  
Kristien Van der Elst ◽  
Ann Matthys ◽  
Michelle Tran ◽  
Isabelle Gilloteau
Keyword(s):  
Rheumatoid Arthritis ◽  
Sleep Quality ◽  
Disease Activity ◽  
Daytime Sleepiness ◽  
Sleep Problems ◽  
Short Form ◽  
Negative Relationship ◽  
Additional Patient ◽  
Equation Modeling ◽  
Patient Reported

Objective.To investigate sleep problems, and the relationship between sleep and disease activity, in Belgian patients with established rheumatoid arthritis (RA).Methods.This cross-sectional, observational, multicenter study assessed sleep quality using the Athens Insomnia Scale (AIS) and Pittsburgh Sleep Quality Index (PSQI), and daytime sleepiness using the Epworth Sleepiness Scale (ESS). Additional patient-reported outcomes included visual analog scales (VAS) for fatigue and pain, the Medical Outcomes Study Short Form-36 Health Survey, the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the Positive and Negative Affect Schedule. Multivariate regression and structural equation modeling identified factors associated with sleep quality, with the 28-joint Disease Activity Score [DAS28-C-reactive protein (CRP)] as a continuous or categorical variable. Analyses were performed on the total population and on patients stratified by disease activity status: remission/low (DAS28-CRP ≤ 3.2) or moderate to high (DAS28-CRP > 3.2).Results.Among 305 patients, mean (SD) age was 57.00 (12.38) years and mean (SD) disease duration was 11.77 (9.94) years. Mean (SD) AIS, PSQI, and ESS scores were 6.8 (4.79), 7.8 (4.30), and 7.3 (4.67), respectively. Mean (SD) VAS fatigue, VAS pain, and HAQ-DI were 45.22 (26.29), 39.04 (26.21), and 1.08 (0.75), respectively. There were significant positive relationships between DAS28-CRP and AIS/PSQI, but a significant negative relationship between DAS28-CRP and ESS. Several potentially confounding factors were identified.Conclusions.Poor control of RA is associated with a reduction in sleep quality and decreased daytime sleepiness, which is likely explained by pain-related alertness. Future prospective studies are needed to confirm potential relationships between sleep quality, sleepiness, and RA treatment.

Discriminant Capacity of Clinical Efficacy and Nonsteroidal Antiinflammatory Drug-sparing Endpoints, Alone or in Combination, in Axial Spondyloarthritis

2015 ◽  
Vol 42 (12) ◽  
pp. 2361-2368 ◽  
Author(s):  
Maxime Dougados ◽  
Emily Wood ◽  
Laure Gossec ◽  
Arnaud Dubanchet ◽  
Isabelle Logeart ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Statistical Significance ◽  
Antiinflammatory Drug ◽  
Nonsteroidal Antiinflammatory Drug ◽  
Controlled Study ◽  
Biologic Treatment ◽  
Link Type

Objective.Using data from a randomized, double-blind, placebo-controlled study, we assessed the capacity of clinical and nonsteroidal antiinflammatory drug (NSAID)-sparing endpoints, alone and in combination, to discriminate between treatment effects in axial spondyloarthritis (axSpA).Methods.Patients with active NSAID-resistant axSpA received etanercept (ETN) 50 mg/week or placebo for 8 weeks and tapered/discontinued NSAID. In posthoc logistic regression analyses, OR were calculated that indicated the capacity of the following endpoints to discriminate between the effects of ETN and placebo at Week 8: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50; BASDAI ≤ 3; Assessment of Spondyloarthritis international Society (ASAS) 20; ASAS40; Ankylosing Spondylitis Disease Activity Score (ASDAS) with C-reactive protein (CRP) < 1.3 and ASDAS-CRP < 2.1; ≥ 50% decrease from baseline in ASAS-NSAID score, score < 10, and score = 0; and each clinical and/or each NSAID measure.Results.In 90 randomized patients (ETN, n = 42; placebo, n = 48), disease activity was similar between groups at baseline: mean (± SD) BASDAI (ETN vs placebo) 6.0 ± 1.6 versus 5.9 ± 1.5. NSAID intake was high: ASAS-NSAID score 98.2 ± 39.0 versus 93.0 ± 23.4. OR ranged from 1.6 (95% CI 0.5–5.4) for ASDAS-CRP < 1.3 to 5.8 (95% CI 1.2–29.1) for BASDAI50 and NSAID score of 0; most measures (34/45) reached statistical significance (α = 0.05) favoring ETN. Most combined outcome variables using OR were more discriminant than single outcome measures.Conclusion.These findings suggest that changes in NSAID intake during treatment do not prevent demonstration of clinically relevant effects of biologic treatment, and combined (i.e., clinical with NSAID-sparing) endpoints were frequently more discriminant than single (i.e., clinical) endpoints. ClinicalTrials.gov (NCT01298531).

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