scholarly journals Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110038
Author(s):  
Irene E. van der Horst-Bruinsma ◽  
Rianne E. van Bentum ◽  
Frank D. Verbraak ◽  
Atul Deodhar ◽  
Thomas Rath ◽  
...  
Keyword(s):  
Anterior Uveitis ◽  
Axial Spondyloarthritis ◽  
Event Rate ◽  
Certolizumab Pegol ◽  
Human Leukocyte ◽  
Primary Analysis ◽  
Open Label ◽  
Flare Event ◽  
Patients At Risk ◽  
History Of

Introduction: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU. Patients and methods: C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks’ CZP versus 2 years pre-baseline. Results: Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12–0.28), p < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified. Conclusion: CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU. Trial Registration ClinicalTrials.gov: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992

scholarly journals The impact of certolizumab pegol treatment on the incidence of anterior uveitis flares in patients with axial spondyloarthritis: 48-week interim results from C-VIEW

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001161 ◽  
Author(s):  
Irene van der Horst-Bruinsma ◽  
Rianne van Bentum ◽  
Frank D Verbraak ◽  
Thomas Rath ◽  
James T Rosenbaum ◽  
...  
Keyword(s):  
Incidence Rate ◽  
Anterior Uveitis ◽  
Poisson Regression ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Tnf Inhibitor ◽  
Open Label ◽  
Before And After ◽  
History Of ◽  
The Impact

BackgroundAcute anterior uveitis (AAU) is the most common extra-articular manifestation in patients with axial spondyloarthritis (axSpA). C-VIEW investigates the impact of the Fc-free TNF inhibitor certolizumab pegol (CZP) on AAU flares in patients with active axSpA at high risk of recurrent AAU.MethodsC-VIEW (NCT03020992) is a 96-week ongoing, multicentre, open-label, phase 4 study. Included patients had an axSpA diagnosis, a history of recurrent AAU (≥2 AAU flares, ≥1 flare in the year prior to study entry), HLA-B27 positivity, active disease, and failure of ≥2 non-steroidal anti-inflammatory drugs. Patients received CZP 400 mg at Weeks 0/2/4, then 200 mg every 2 weeks up to 96 weeks. This 48-week pre-planned interim analysis compares AAU flare incidence in the 48 weeks before and after initiation of CZP treatment, using Poisson regression to account for possible within-patient correlations.ResultsIn total, 89 patients were included (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean axSpA disease duration: 8.6 years). During 48 weeks’ CZP treatment, 13 (15%) patients experienced 15 AAU flares, representing an 87% reduction in AAU incidence rate (146.6 per 100 patient-years (PY) in the 48 weeks pre-baseline to 18.7 per 100 PY during CZP treatment). Poisson regression analysis showed that the incidence rate of AAU per patient reduced from 1.5 to 0.2 (p<0.001). No new safety signals were identified.ConclusionsThere was a significant reduction in the AAU flare rate during 48 weeks of CZP treatment, indicating that CZP is a suitable treatment option for patients with active axSpA and a history of recurrent AAU.

scholarly journals Is a positive family history of spondyloarthritis relevant for diagnosing axial spondyloarthritis once HLA-B27 status is known?

Rheumatology ◽  
2019 ◽  
Vol 58 (9) ◽  
pp. 1649-1654 ◽  
Author(s):  
Miranda van Lunteren ◽  
Désirée van der Heijde ◽  
Alexandre Sepriano ◽  
Inger J Berg ◽  
Maxime Dougados ◽  
...  
Keyword(s):  
Back Pain ◽  
Family History ◽  
Anterior Uveitis ◽  
Chronic Back Pain ◽  
Axial Spondyloarthritis ◽  
Positive Family History ◽  
Hla B27 ◽  
Acute Anterior Uveitis ◽  
Negative Results ◽  
History Of

Abstract Objectives A positive family history (PFH) of spondyloarthritis, in particular a PFH of AS or acute anterior uveitis, is associated with HLA-B27 carriership in chronic back pain patients. As it is unknown, the study aimed to investigate if a PFH contributes to diagnosing axial spondyloarthritis (axSpA) once HLA-B27 status is known. Methods In axSpA-suspected patients from the Assessment of SpondyloArthritis international Society (ASAS), DEvenir des Spondyloarthropathies Indifférenciéés Récentes (DESIR) and SPondyloArthritis Caught Early (SPACE) cohorts, logistic regression analyses were performed with HLA-B27 status and PFH according to the ASAS definition (ASAS-PFH) as determinants and clinical axSpA diagnosis as outcome at baseline. Analyses were repeated with a PFH of AS or acute anterior uveitis. Results In total, 1818 patients suspected of axSpA were analysed (ASAS n = 594, DESIR n = 647, and SPACE n = 577). In patients from the ASAS, DESIR and SPACE cohorts, respectively 23%, 39% and 38% had an ASAS-PFH, 52%, 58% and 43% were HLA-B27 positive, and 62%, 47% and 54% were diagnosed with axSpA. HLA-B27 was independently associated with an axSpA diagnosis in each cohort but an ASAS-PFH was not [ASAS cohort: HLA-B27 odds ratio (OR): 6.9 (95% CI: 4.7, 10.2), ASAS-PFH OR: 0.9 (95% CI: 0.6, 1.4); DESIR: HLA-B27 OR: 2.1 (95% CI: 1.5, 2.9), ASAS-PFH OR: 1.0 (95% CI 0.7, 1.3); SPACE: HLA-B27 OR: 10.4 (95% CI: 6.9, 15.7), ASAS-PFH OR: 1.0 (95% CI: 0.7, 1.5)]. Similar negative results were found for PFH of AS and acute anterior uveitis. Conclusion In three independent cohorts with different ethnical backgrounds, ASAS, DESIR and SPACE, a PFH was not associated independently of HLA-B27 with a diagnosis of axSpA. This indicates that in the vast majority of patients presenting with back pain, a PFH does not contribute to the likelihood of an axSpA diagnosis if HLA-B27 status is known.

scholarly journals Adalimumab effectively reduces the rate of anterior uveitis flares in patients with active ankylosing spondylitis: results of a prospective open-label study

2008 ◽  
Vol 68 (5) ◽  
pp. 696-701 ◽  
Author(s):  
M Rudwaleit ◽  
E Rødevand ◽  
P Holck ◽  
J Vanhoof ◽  
M Kron ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Treatment Period ◽  
Anterior Uveitis ◽  
Recent History ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Chronic Uveitis ◽  
Adalimumab Treatment ◽  
History Of

Objective:To evaluate the effect of adalimumab on the frequency of anterior uveitis (AU) flares in patients with active ankylosing spondylitis (AS).Methods:We determined the history of ophthalmologist-diagnosed AU in 1250 patients with active AS who were enrolled in a multinational, open-label, uncontrolled clinical study of treatment with adalimumab, 40 mg every other week for up to 20 weeks. All AU flares were documented throughout the adalimumab treatment period plus 70 days. We compared the rates of AU flares per 100 patient years (PYs) reported during the year before adalimumab treatment with rates during adalimumab treatment, in total and by patient subgroups.Results:The AU flare rates before adalimumab treatment were 15/100 PYs in all patients (n = 1250), 68.4/100 PYs in 274 patients with a history of AU flares, 176.9/100 PYs in 106 patients with a recent history of AU flares, 192.9/100 PYs in 28 patients with symptomatic AU at baseline and 129.1/100 PYs in 43 patients with a history of chronic uveitis. During adalimumab treatment, the rate of AU flares was reduced by 51% in all patients, by 58% in 274 patients with a history of AU, by 68% in 106 patients with a recent history of AU, by 50% in 28 patients with symptomatic AU at baseline and by 45% in 43 patients with chronic uveitis. AU flares during adalimumab treatment were predominantly mild. Two patients with periods of high AS disease activity had new-onset AU during the treatment period.Conclusions:Results of this prospective open-label study suggest that adalimumab had a substantial preventive effect on AU flares in patients with active AS, including patients with a recent history of AU flares.Clinical trials:ClinicalTrials.gov Identifier: NCT00478660.

scholarly journals REDUCTION OF ANTERIOR UVEITIS FLARES IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS DURING CERTOLIZUMAB PEGOL TREATMENT: 96-WEEK RESULTS FROM THE C-VIEW STUDY

2021 ◽  
Author(s):  
Rodrigo Luppino Assad ◽  
Irene van der Horst-Bruinsma ◽  
Rianne E. van Bentum ◽  
Frank D. Verbraak ◽  
Thomas Rath ◽  
...  
Keyword(s):  
Anterior Uveitis ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol

scholarly journals POS0937 TREATMENT SURVIVAL ON BIOLOGICS IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS – DATA FROM MOSCOW UNIFIED ARTHRITIS REGISTRY (MUAR)

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 731.3-732
Author(s):  
K. Lytkina ◽  
E. Koltsova ◽  
E. Rozochkina ◽  
E. Shmidt ◽  
G. Lukina ◽  
...  
Keyword(s):  
Cox Regression ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Total Duration ◽  
Hazard Ratio ◽  
Treatment Withdrawal ◽  
Biologic Treatment ◽  
Stepwise Variable Selection ◽  
History Of ◽  
Forward Stepwise

Background:The number of new biologics in treatment of axial spondyloarthritis (axSpA) is rapidly increasing. It is important to assess timely their place in the treatment of axSpA, especially with regard to retention on therapy.Objectives:To compare retention on therapy with different biologics in patients with axSpA.Methods:We retrospectively analyzed the data of axSpA patients receiving biologics from the MUAR register. Predictors of retention on therapy were selected by forward stepwise variable selection within Cox regression proportional hazard model. These predictors were considered as confounders when comparing the risks of biologics withdrawal.Results:990 treatment episodes in 640 patients with axSpA were analyzed (non-radiographic axSpA – 4.1%, ankylosing spondylitis - 95.9%). The duration of episodes was 824±920 days. Men were 66,6%, mean age 46,4±11,4.The patients were treated with Adalimumab (ADA) (n= 252 treatment episodes), Golimumab (GOL) (n=82), Infliximab (INF) (n=167), Netakimab (NET) (n=9), Secukinumab (SEC) (n=75), Certolizumab pegol (CER) (n=66), Etanercept (ETA) (n=339).The following predictors of withdrawal risk were identified –1.The total duration of the disease2.The duration of the disease before the onset of biologic treatment3.Gender4.Family history of non-inflammatory spondylopathy (degenerative spinal disease)5.The line of biologic treatment6.The level of educationThe severity of radiographic sacroiliitis and HLA B-27 positivity were not associated with the risk of discontinuation of biologics.The identified predictors were further considered as confounders. Adjusted for confounders, ETA had the lowest treatment withdrawal risk (Figure 1). ADA, GOL, INF, SEC, CER had significantly higher risk of withdrawal compared with ETA (Table 1).Conclusion:Our analysis detected predictors associated with risk of biologics withdrawal in axSpA patients in real clinical practice. There are significant differences between biologics regarding retention on treatment.Table 1.Hazard ratio for treatment withdrawalDrugHazard ratio (Exp B)pADA1.52*0.004GOL2.95*0.000INF2.574*0.000NET3.680*0.073SEC2.133*0.005CER2.922*0.000*- withdrawal risk relative to ETAFigure 1.Picture 1. Treatment withdrawal riskDisclosure of Interests:None declared

scholarly journals Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction

2020 ◽  
Vol 79 (7) ◽  
pp. 920-928 ◽  
Author(s):  
Robert BM Landewé ◽  
Désirée van der Heijde ◽  
Maxime Dougados ◽  
Xenofon Baraliakos ◽  
Filip E Van den Bosch ◽  
...  
Keyword(s):  
Clinical Remission ◽  
Maintenance Dose ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Sustained Remission ◽  
Open Label ◽  
Double Blind ◽  
Multicentre Phase ◽  
Factor Inhibitor ◽  
Registration Number

BackgroundThe best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor certolizumab pegol (CZP) following achievement of sustained remission in patients with early axSpA.MethodsC-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at Weeks 32/36 and 48) were randomised to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg every 4 weeks (Q4W; reduced maintenance dose) or placebo (withdrawal) for a further 48 weeks. The primary endpoint was remaining flare-free (flare: ASDAS ≥2.1 at two consecutive visits or ASDAS >3.5 at any time point) during the double-blind period.ResultsAt Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p<0.001 vs placebo in both CZP groups). Responses in radiographic and non-radiographic axSpA patients were comparable.ConclusionsPatients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal.Trial registration numberNCT02505542, ClinicalTrials.gov.

scholarly journals Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial

2018 ◽  
Vol 77 (5) ◽  
pp. 699-705 ◽  
Author(s):  
Désirée van der Heijde ◽  
Xenofon Baraliakos ◽  
Kay-Geert A Hermann ◽  
Robert B M Landewé ◽  
Pedro M Machado ◽  
...  
Keyword(s):  
New York ◽  
Ankylosing Spondylitis ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Randomised Trial ◽  
Phase Iii ◽  
Open Label ◽  
Double Blind ◽  
Link Type ◽  
Registration Number

ObjectivesTo report 4-year imaging outcomes in the RAPID-axSpA (NCT01087762) study of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), treated with certolizumab pegol (CZP).MethodsThis phase III, randomised trial was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204. Patients fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria with active disease were stratified (AS/nr-axSpA) according to the modified New York (mNY) criteria at randomisation. Spinal radiographs were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). MRI inflammation used the Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac joints (SIJ) and the Berlin spinal score (remission defined as SPARCC <2 and Berlin ≤2, respectively).ResultsMRI improvements from baseline (BL) to week 12 were maintained to week 204 (SPARCC BL: AS=8.5, nr-axSpA=7.5; SPARCC week 204: AS=1.3, nr-axSpA=2.4; Berlin BL: AS=7.4, nr-axSpA=4.4; Berlin week 204: AS=2.6, nr-axSpA=1.9). 66.7% of patients with AS and 69.6% of patients with nr-axSpA with BL SPARCC scores ≥2, and 65.4% of patients with AS and 57.3% of patients with nr-axSpA with BL Berlin score >2, achieved remission at week 204. Mean mSASSS change in AS from BL to week 204 was 0.98 (95% CI 0.34, 1.63); 0.67 (95% CI 0.21,1.13) from BL to week 96; and 0.31 (95% CI 0.02,0.60) from week 96 to week 204. Corresponding nr-axSpA changes were 0.06 (95% CI −0.17,0.28), –0.01 (95% CI −0.19,0.17) and 0.07 (95% CI −0.07,0.20). 4.5% of patients with nr-axSpA fulfilled the mNY criteria at week 204, while 4.3% of patients with AS no longer did so.ConclusionsIn patients with CZP-treated axSpA, rapid decreases in spinal and SIJ MRI inflammation were maintained to week 204. Overall, 4-year spinal progression was low, with less progression during years 2–4 than 0–2. Radiographic SIJ grading changes demonstrated limited progression.Trial registration numberNCT01087762; Post-results.

Comparison of Non-radiographic Axial Spondyloarthritis and Ankylosing Spondyltis from a Single Rheumatology Hospital in Morocco

2020 ◽  
Vol 16 (3) ◽  
pp. 240-244 ◽  
Author(s):  
Nessrine Akasbi ◽  
Siar Nihad ◽  
Zoukal Sofia ◽  
El Kohen Khadija ◽  
Harzy Taoufik
Keyword(s):  
Disease Burden ◽  
Axial Spondyloarthritis ◽  
Univariate Analysis ◽  
Cross Sectional Study ◽  
Low Back ◽  
New Classification ◽  
Cross Sectional ◽  
Asas Criteria ◽  
History Of ◽  
High Level

Background: According to the new classification criteria developed by The Assessment of SpondyloArthritis International Society, patients with axial spondyloarthritis (axSpA) can be classified in 2 subgroups: Patients with radiographic axial spondyloarthritis: ankylosing spondylitis patients (AS) and those with non-radiographic axial spondyloarthritis (nr-axSpA). Objective: The aim of the present study is to describe and discuss the differences and similarities between the two subgroups. Patients and Methods: A cross-sectional study was conducted in a single rheumatology hospital in Morocco. These included patients diagnosed as having axial spondyloarthritis according to ASAS criteria 2010, during a period of 6 years. The AS and the nr-axSpA subgroups were compared for the various axSpA-related variables. Results: Of the 277 patients with a diagnosis of axial SpA who were included in this study, 160 had AS and 117 had nr-axSpA. AS and nr-ax-SpA shared a similar age at diagnosis, similar prevalence of low back pain, lumbar stiffness, extra-articular manifestations, BASDAI and BASFI. In the multivariate analysis, AS patients were mainly male with cervical stiffness, enthesitis, coxitis and high level of ESR (erythrocyte sedimentation rate). The females generally had a family history of SpA and arthritis and were associated to the nr-axSpA form in the univariate analysis. Conclusion: This was the first study to characterise patients with AS and nr-axSpA in Morocco. Consistent with other studies published, this study showed that patients with nr-axSpA and patients with AS shared a comparable degree of disease burden.

scholarly journals Effect of tofogliflozin on arterial stiffness in patients with type 2 diabetes: prespecified sub-analysis of the prospective, randomized, open-label, parallel-group comparative UTOPIA trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Naoto Katakami ◽  
◽  
Tomoya Mita ◽  
Hidenori Yoshii ◽  
Toshihiko Shiraiwa ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Conventional Treatment ◽  
Mixed Effects ◽  
Mixed Effects Models ◽  
Open Label ◽  
Parallel Group ◽  
History Of

Abstract Background Tofogliflozin, an SGLT2 inhibitor, is associated with favorable metabolic effects, including improved glycemic control and serum lipid profile and decreased body weight, visceral adipose tissue, and blood pressure (BP). This study evaluated the effects of tofogliflozin on the brachial-ankle pulse wave velocity (baPWV) in patients with type 2 diabetes (T2DM) without a history of apparent cardiovascular disease. Methods The using tofogliflozin for possible better intervention against atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. As one of the prespecified secondary outcomes, changes in baPWV over 104 weeks were evaluated in 154 individuals (80 in the tofogliflozin group and 74 in the conventional treatment group) who completed baPWV measurement at baseline. Results In a mixed-effects model, the progression in the right, left, and mean baPWV over 104 weeks was significantly attenuated with tofogliflozin compared to that with conventional treatment (– 109.3 [– 184.3, – 34.3] (mean change [95% CI] cm/s, p = 0.005; – 98.3 [– 172.6, – 24.1] cm/s, p = 0.010; – 104.7 [– 177.0, – 32.4] cm/s, p = 0.005, respectively). Similar findings were obtained even after adjusting the mixed-effects models for traditional cardiovascular risk factors, including body mass index (BMI), glycated hemoglobin (HbA1c), total cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, systolic blood pressure (SBP), hypertension, smoking, and/or administration of drugs, including hypoglycemic agents, antihypertensive agents, statins, and anti-platelets, at baseline. The findings of the analysis of covariance (ANCOVA) models, which included the treatment group, baseline baPWV, and traditional cardiovascular risk factors, resembled those generated by the mixed-effects models. Conclusions Tofogliflozin significantly inhibited the increased baPWV in patients with T2DM without a history of apparent cardiovascular disease, suggesting that tofogliflozin suppressed the progression of arterial stiffness. Trial Registration UMIN000017607. Registered 18 May 2015. (https://www.umin.ac.jp/icdr/index.html)

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