scholarly journals Long-term effectiveness and safety of infliximab, golimumab and ustekinumab in patients with psoriatic arthritis from a Canadian prospective observational registry

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e036245 ◽  
Author(s):  
Proton Rahman ◽  
Regan Arendse ◽  
Majed Khraishi ◽  
Dalton Sholter ◽  
Maqbool Sheriff ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Survival Rates ◽  
Severity Index ◽  
Biologic Treatment ◽  
Psoriasis Area Severity Index ◽  
Link Type ◽  
Over Time ◽  
Disease Parameters

ObjectivesThe objectives of this study were to describe the demographic profile and baseline disease characteristics of patients with psoriatic arthritis (PsA) treated with either infliximab (IFX), subcutaneous golimumab (GLM) or ustekinumab (UST) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety.MethodsPatients with PsA were enrolled into the Biologic Treatment Registry Across Canada registry (ClinicalTrials.gov Identifier: NCT00741793) from 2005 to 2017. The study visits occurred at study enrolment (baseline) and every 6 months thereafter. Effectiveness was assessed by changes in disease parameters (joint counts, Psoriasis Area Severity Index (PASI), Health Assessment Questionnaire, patient/physician global, minimal disease activity, enthesitis, dactylitis, erythrocyte sedimentation rate, C reactive protein). Improvements from baseline were explored with the paired t-test and the McNemar’s test. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates.ResultsA total of 111 IFX-treated, 281 GLM-treated and 70 UST-treated patients were enrolled. Most baseline disease parameters remained similar over time in all three cohorts. UST-treated patients had lower mean baseline Disease Activity Score in 28 joints CRP, swollen joint based on 28 joints and higher PASI compared with patients treated with GLM. Treatment with IFX, GLM and UST was associated with significant improvements in all disease parameters over time (p<0.001) from baseline up to 84, 84 and 40 months, respectively.AEs were reported for 74.8%, 69.8% and 52.9% (138, 114 and 115 events/100 patient-years (PYs)) covering 325, 567 and 87 years of exposure for IFX-treated, GLM-treated and UST-treated patients, respectively. Severe AEs were reported in 19.8%, 8.5% and 5.7% (8.8, 7.2 and 8.0 events/100 PYs) in IFX-treated, GLM-treated and UST-treated patients, respectively. The proportion of patients who discontinued treatment were 63.1%, 50.9% and 50.0%, respectively.ConclusionsIFX, GLM and UST treatment significantly reduced disease activity and improved functionality in patients with PsA followed by routine clinical practice and had a safety profile similar to that previously reported in the literature.Trial registration numberNCT00741793.

scholarly journals Long-Term Effectiveness and Safety of Infliximab and Golimumab in Ankylosing Spondylitis Patients from a Canadian Prospective Observational Registry

2020 ◽  
Author(s):  
Proton Rahman ◽  
Michael Starr ◽  
Derek Haaland ◽  
Louis Bessette ◽  
Michelle Teo ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Survival Rates ◽  
Similar Efficacy ◽  
Routine Care ◽  
Acute Phase Reactants ◽  
Very High ◽  
Over Time ◽  
Disease Parameters

Abstract Background: The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety. Methods: AS patients who were eligible for treatment with IFX or subcutaneous GLM as per their respective Canadian product monographs were enrolled into the BioTRAC registry from 2005-2017. The study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in clinical outcomes and acute phase reactants. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates. Results: A total of 389 IFX- and 421 GLM-treated patients were enrolled. A significant decrease in disease duration at baseline was observed in the IFX cohort, from a median of 8.0 in 2005-2008 to 1.0 years in 2009-2015 (p<0.001). A reduction in baseline BASFI score (p=0.011) and proportion of patients in ASDAS very high disease activity (p=0.004) was also observed over time. Meanwhile, in the GLM cohort, most disease parameters remained similar from 2010-2017.Treatment with both agents significantly improved all disease parameters over time with similar efficacy between the two agents. The incidence of AEs and SAEs were 136 and 131 events/100 PYs and 10.5 and 8.45 events/100 PYs for IFX- and GLM-treated patients, respectively. Conclusion: Both IFX and GLM treatment in AS significantly reduced disease activity in most outcome measures in a similar fashion and were well tolerated in Canadian routine care. Trial Registration: NCT00741793

scholarly journals Long-Term Effectiveness and Safety of Infliximab and Golimumab in Ankylosing Spondylitis Patients from a Canadian Prospective Observational Registry

2020 ◽  
Author(s):  
Proton Rahman ◽  
Michael Starr ◽  
Derek Haaland ◽  
Louis Bessette ◽  
Michelle Teo ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Survival Rates ◽  
Similar Efficacy ◽  
Routine Care ◽  
Acute Phase Reactants ◽  
Very High ◽  
Over Time ◽  
Disease Parameters

Abstract Background: The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety. Methods: AS patients who were eligible for treatment with IFX or subcutaneous GLM as per their respective Canadian product monographs were enrolled into the BioTRAC registry from 2005-2017. The study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in clinical outcomes and acute phase reactants. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates. Results: A total of 389 IFX- and 421 GLM-treated patients were enrolled. A significant decrease in disease duration at baseline was observed in the IFX cohort, from a median of 8.0 in 2005-2008 to 1.0 years in 2009-2015 (p<0.001). A reduction in baseline BASFI score (p=0.011) and proportion of patients in ASDAS very high disease activity (p=0.004) was also observed over time. Meanwhile, in the GLM cohort, most disease parameters remained similar from 2010-2017.Treatment with both agents significantly improved all disease parameters over time with similar efficacy between the two agents. The incidence of AEs and SAEs were 136 and 131 events/100 PYs and 10.5 and 8.45 events/100 PYs for IFX- and GLM-treated patients, respectively. Conclusion: Both IFX and GLM treatment in AS significantly reduced disease activity in most outcome measures in a similar fashion and were well tolerated in Canadian routine care. Trial Registration: NCT00741793

scholarly journals Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Proton Rahman ◽  
Michael Starr ◽  
Derek Haaland ◽  
Louis Bessette ◽  
Michelle Teo ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Survival Rates ◽  
Similar Efficacy ◽  
Routine Care ◽  
Acute Phase Reactants ◽  
Very High ◽  
Over Time ◽  
Disease Parameters

Abstract Background The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety. Methods AS patients who were eligible for treatment with IFX or subcutaneous GLM as per their respective Canadian product monographs were enrolled into the BioTRAC registry from 2005 to 2017. The study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in clinical outcomes and acute phase reactants. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates. Results A total of 389 IFX- and 421 GLM-treated patients were enrolled. A significant decrease in disease duration at baseline was observed in the IFX cohort, from a median of 8.0 in 2005–2008 to 1.0 years in 2009–2015 (p < 0.001). A reduction in baseline BASFI score (p = 0.011) and proportion of patients in ASDAS very high disease activity (p = 0.004) was also observed over time. Meanwhile, in the GLM cohort, most disease parameters remained similar from 2010 to 2017. Treatment with both agents significantly improved all disease parameters over time with similar efficacy between the two agents. The incidence of AEs and SAEs were 136 and 131 events/100 PYs and 10.5 and 8.45 events/100 PYs for IFX- and GLM-treated patients, respectively. Conclusion Both IFX and GLM treatment in AS significantly reduced disease activity in most outcome measures in a similar fashion and were well tolerated in Canadian routine care. Trial registration NCT00741793.

scholarly journals Measuring treatment effect on psoriatic arthritis-related domains: insights from the SPIRIT-H2H study at weeks 24 and 52

2021 ◽  
Author(s):  
Frank Behrens ◽  
Soyi Liu Leage ◽  
Christophe Sapin ◽  
Celine El Baou ◽  
Inmaculada De La Torre ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Severity Index ◽  
Psoriasis Area Severity Index ◽  
American College Of Rheumatology ◽  
Related Quality ◽  
Health Related ◽  
Musculoskeletal Manifestations ◽  
Response Groups

Abstract Introduction Improvements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA). Objective These post hoc analyses determined whether additional benefits related to various PsA domains are observed in patients simultaneously achieving 50% improvement in American College of Rheumatology criteria (ACR50) and 100% improvement in Psoriasis Area Severity Index (PASI100), the primary endpoint of the SPIRIT-H2H study. Methods Patients with active PsA and psoriasis in SPIRIT-H2H (N = 566) were categorised into two sets of four response groups irrespective of treatment allocation (approved dosages of ixekizumab or adalimumab): patients who simultaneously achieved ACR50 and PASI100 response, achieved ACR50 response only, achieved PASI100 response only, or did not achieve ACR50 or PASI100 response after 24 and 52 weeks of treatment. Patients achieving simultaneous ACR50 and PASI100 response were compared with the other patient response groups at the corresponding time point for efficacy and health-related quality of life (HRQoL) outcomes. Results Patients simultaneously achieving ACR50 and PASI100 responses at week 24 or 52 showed higher rates of ACR70 response, minimal disease activity, Disease Activity in Psoriatic Arthritis ≤ 4, resolution of enthesitis and dactylitis, and HRQoL improvement at weeks 24 and 52, respectively, than the other corresponding response groups at both time points. Conclusion High levels of disease control, such as those obtained with simultaneous achievement of ACR50 and PASI100 response, were linked to better outcomes across a wide range of endpoints that are important for patients with PsA. Patients meeting this combined endpoint showed more comprehensive and thus greater control of disease activity. Trial registration NCT03151551 Key Points• Treatment goals for patients with psoriatic arthritis emphasise the importance of improving both musculoskeletal and non-musculoskeletal manifestations of the disease.• A combined endpoint considering both these manifestations, achievement of at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index, was linked with achievement of a number of other endpoints relevant to psoriatic arthritis, including health-related quality of life that are important to patients with psoriatic arthritis.• Patients meeting the combined endpoint were more likely to achieve a disease state of remission, which is the stated aim of treatment for psoriasis.

scholarly journals The Impact of Intermittent Fasting (Ramadan Fasting) on Psoriatic Arthritis Disease Activity, Enthesitis, and Dactylitis: A Multicentre Study

Nutrients ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 601 ◽  
Author(s):  
Mohammad Adawi ◽  
Giovanni Damiani ◽  
Nicola Bragazzi ◽  
Charlie Bridgewood ◽  
Alessia Pacifico ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Positive Impact ◽  
Activity Index ◽  
Disease Activity Index ◽  
Severity Index ◽  
Intermittent Fasting ◽  
Psoriasis Area Severity Index ◽  
Reactive Protein ◽  
The Impact

Intermittent circadian fasting, namely Ramadan, is a common worldwide practice. Such fasting has a positive impact on psoriasis, but no data exist on its role in psoriatic arthritis (PsA)—a disease that is clearly linked to body mass index. We enrolled 37 patients (23 females and 14 males) with a mean age 43.32 ± 7.81 and they fasted for 17 h for one month in 2016. The baseline PsA characteristics were collected and 12 (32.4%) patients had peripheral arthritis, 13 (35.1%) had axial involvement, 24 (64.9%) had enthesitis, and 13 (35.1%) had dactylitis. Three patients (8.1%) were treated with methotrexate, 28 (75.7%) with TNF-α blockers, and 6 (16.2%) with IL-17 blockers. After a month of intermittent fasting, C-reactive protein (CRP) levels decreased from 14.08 ± 4.65 to 12.16 ± 4.46 (p < 0.0001), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) decreased from 2.83 ± 1.03 to 2.08 ± 0.67 (p = 0.0078), Psoriasis Area Severity Index (PASI) decreased from 7.46 ± 2.43 to 5.86 ± 2.37 (p < 0.0001), and Disease Activity index for PSoriatic Arthritis (DAPSA) decreased from 28.11 ± 4.51 to 25.76 ± 4.48 (p < 0.0001). Similarly, enthesitis improved after fasting, with Leeds Enthesitis Index (LEI) decreasing from 2.25 ± 1.11 to 1.71 ± 0.86 (p < 0.0001) and dactylitis severity score (DSS) decreasing from 9.92 ± 2.93 to 8.54 ± 2.79 (p = 0.0001). Fasting was found to be a predictor of a decrease in PsA disease activity scores (DAPSA, BASDAI, LEI, DSS) even after adjustment for weight loss. IL-17 therapy was found to be an independent predictor of decreases in LEI after fasting. These preliminary data may support the use of chronomedicine in the context of rheumatic diseases, namely PsA. Further studies are needed to support our findings.

SAT0423 LONG-TERM SURVIVAL OF THE FIRST BIOLOGIC TREATMENT IN PSORIATIC ARTHRITIS AND THE EFFECT OF THE SELECTED TREATMENT ON DRUG SURVIVAL; TURKBIO REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1165-1166
Author(s):  
S. B. Kocaer ◽  
T. Yüce İnel ◽  
Y. Erez ◽  
A. Köken Avşar ◽  
S. Uslu ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Survival Rates ◽  
Biologic Agent ◽  
Biologic Drugs ◽  
Biologic Treatment ◽  
Necrosis Factor Alpha ◽  
Term Survival ◽  
Drug Survival ◽  
Significant Difference

Background:Currently, biologic treatments are used effectively in patients with psoriatic arthritis (PsA).Objectives:The aim of this study was to evaluate and compare long-term drug survival of the first biologic treatments including adalimumab, certolizumab, etanercept, golimumab, infliximab, secukinumab and ustekinumab in patients with PsA.Methods:PsA patients, electronically registered at each visit in the TURKBIO database between 2011 and 2019 were included in the study. PASW 18.0 for Windows was used for statistical analysis. Drug survival rates were calculated by Kaplan Meier method.Results:355 patients (227 women; axial PsA = 48, peripheral PsA = 307) were included in the study (Table 1). Adalimumab was the most commonly used first biologic treatment (n=125; 37.6%). The rate of drug survival was found to be 0.75 at month 60 in patients receiving the first biologic treatment (Figure 1). There was no significant difference in drug survival rate between tumor necrosis factor alpha inhibitor (TNFi) and non-TNFi biologic drugs (p=0.56). No difference was also found in drug survival rates between each biologic treatment.Table 1.Initial demographic and clinical datas of patients with PsAPsA Patients (n=355)Females, n (%)227 (63,9)Age of diagnosis, years*34,6 (27-42)CRP baseline*6 mg/ L (3-15)ESR baseline*24 mm/h (10-38)Smoking, n (%)Current99 (28,5)Never192 (55,3)Previous56 (16,2)HLA B27 positivity,n (%)41 (26,4)First biologic agent, n (%)-TNFi332 (95,4)AdalimumabEtanercept125 (37,6)80 (24,1)Golimumab52 (15,6)Certolizumab44 (13,3)Infliximab31 (9,4)- Other biologic agents16 (4,6)Secukinumab13 (81,3)Ustekinumab3 (18,7)*median (min-max)Conclusion:The results of this study establish that more than half of patients with PsA can remain in their initial biologic treatment over a long term. It has been observed that the choice of biologic treatment did not effect the drug survival in PsA.Disclosure of Interests:None declared

scholarly journals SAT0415 AGE RELATIONSHIP WITH ULTRASOUND ARTICULAR AND ENTHESEAL INVOLVEMENT IN PSORIATIC ARTHRITIS: CROSS-SECTIONAL STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1160.2-1161
Author(s):  
I. Fairushina ◽  
D. Abdulganieva ◽  
E. Kirillova ◽  
R. Abdrakipov
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Power Doppler ◽  
Severity Index ◽  
Cross Sectional Study ◽  
Blood Biomarkers ◽  
Cross Sectional ◽  
Age Related ◽  
Hs Crp ◽  
Axial Involvement

Background:Detection of subclinical enthesitis and synovitis in psoriatic arthritis (PsA) is prevalent and ultrasound (US) examination is informative tool for it diagnosing. Aging positively affects degenerative changes.Objectives:To study relationship between US articular and entheseal findings with age in patients with PsA.Methods:57 patients were enrolled to study with fulfilled PsA criteria (CASPAR, 2009). Data collection: demographical, clinical (current psoriasis, axial involvement, enthesitis, dactylitis), US (synovitis count (by Grey Scale), Power Doppler(PD)+ synovitis), thickening and hypoechogenicity at enthesis, PD+ enthesitis, entheses with structural components); biological (high sensitive C-reactive protein (hsCRP), Erythrocyte Sedimentation Rate (ESR).US examination included 798 joints and 3078 entheses (bilateral shoulders, acromioclavicular joints, elbows, wrists, hips, knees, ankles; entheses at the projection of these joints (total number - 54). US entheseal findings were fixed according to consensus-based US definition and scoring for enthesitis in spondyloarthritis and PsA (OMERACT US)1.Results:In all 57 patients: male - 25 (43.9%), mean age 43.4±10.3(SD) years (y), PsA duration was 7 (3;10) y, Ps duration 10 (8; 22) y; 53 (41.1%) had axial involvement, 42 (73.7%) dactylitis, 8 (14%) clinical enthesitis, and 56 (98.2 %) skin psoriasis, Psoriasis Activity and Severity Index score 6.4 (2;14.4), Disease Activity in PsA score 18.1 (10.2;26.1), hsCRP 10.1(2.4;21.4), ESR 20 (11.3;31.5).Synovitis count increased with age noticeably (r=0.508, p<0.01), and weak correlation of PD+ synovitis (r=0.262, p=0.049) and age was found. The entheseal thickening and hypoechogenicity and structural findings increased with age respectively (r=0.345, p=0.009; r=0.337, p=0.01). There was no correlation between PD+ enthesitis and age. The assosiation between PD+ enthesitis and blood biomarkers of inflammation (hs-CRP (r=0.364, p=0.008); ESR (p=0.358, p=0.008) was found.Conclusion:Our study found significant relationship between age and US synovitis. Association between age and US entheseal involvement was noted. Only PD+ enthesitis was not related with age in comparison with other US entheseal findings. The presence of PD US signal at enthesitis in association with increased inflammatory blood biomarkers can be evaluated as the sign of disease activity regardless of age and not as age-related lesion in PsA patients.References:[1]Balint PV, Terslev L, Aegerter P et al. Reliability of a consensus-based ultrasound definition and scoring for enthesitis in spondyloarthritis and psoriatic arthritis: an OMERACT US initiative. Ann Rheum Dis.;2018;77(12):1730-1735.Disclosure of Interests:None declared

scholarly journals AB0546 5 YEARS FOLLOW-UP OF PSORIATIC ARTHRITIS PATIENTS TREATED ACCORDING TREAT-TO-TARGET STRATEGY. PRELIMINARY RESULTS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1306.1-1306
Author(s):  
P. Tremaskina ◽  
E. Loginova ◽  
T. Korotaeva ◽  
S. Glukhova ◽  
A. Lila
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Standard Care ◽  
Early Stage ◽  
Treat To Target ◽  
Moderate Activity ◽  
Long Term Outcomes ◽  
Mean Values

Background:The concept of treat to target (T2T) in psoriatic arthritis (PsA) has been established recently and already shown its benefits [1]. But the long-term outcomes of the T2T have not been studied yet.Objectives:To study 5 years (yrs) follow-up of PsA patients (pts) treated according to T2T strategy at the early stage.Methods:35 (M/F–17/18) PsA pts fulfilling CASPAR criteria, who were treated according to T2T strategy at the early stage (PsA duration≤2 yrs) within 24 months (mos) were analyzed. At the time of evaluation mean age is 42.7±11.2 yrs, median (Me) PsA duration 72 [60;95] mos, psoriasis duration 120 [88;180] mos. All pts underwent standard clinical examinations of PsA before started T2T therapy and at follow-up. Within 24 mos of T2T strategy all pts were taking Methotrexate (MTX) monotherapy in increasing dose up to 25 mg/wk and 18 out of 35 (51%) pts received MTX in combination with iTNF. When T2T study was stopped all pts were treated according to standard care with NSAIDs, bDMARDs, MTX, tsDMARDs based on PsA activity and physician decision. The number of pts achieved minimal disease activity (MDA, 5 of 7) and remission by DAPSA (≤4)/low disease activity (LDA)≤14) at the 24 mos of T2T strategy and at 5 yrs follow-up were calculated. The results are presented in the form of mean values, median, upper and lower quartiles.Results:Me duration of follow-up is 68 [53.5;81.5] mos. At 24 mos Me DAPSA 3.48 [0.45;21.76], remission by DAPSA (REM-DAPSA) were seen in 20 out of 35 (57%) pts, LDA-DAPSA in 4 (12%) pts, moderate activity (MoA) by DAPSA in 6 (17%) pts and high disease activity by DAPSA (HDA-DAPSA) in 5 (14%) pts. MDA was noted in 21 out of 35 (60%) pts. At 5 yrs Me DAPSA 7.4 [2.22;13.87], REM-DAPSA was noted in 12 (34%) pts, LDA-DAPSA in 14 (40%), MoA-DAPSA in 5 (14%), HDA-DAPSA in 4 (12%) pts. MDA was observed in 17 of 35 pts (49%). Among 20 pts who had REM-DAPSA at 24 mos only 6 pts (30%) remained in remission at 5 yrs follow-up and 12 out of 21 pts (57.14%) remained in MDA status.Conclusion:In early PsA pts remission and MDA are achievable goal of T2T strategy. But most pts lost remission/MDA after this strategy was changed to a standard care, despite being in remission/MDA status before change of therapy. Further investigations of the long-term outcomes of T2T strategy in PsA, including radiographic outcomes are needed.References:[1]Coates LC, Moverley AR, McParland L, et al. Lancet 2015; 386: 2489–98.Disclosure of Interests:None declared.

scholarly journals Evolution of patient characteristics in the era of biological treatment of psoriatic arthritis: 18-year Belgian experience from the Leuven Spondyloarthritis Biologics Cohort (BioSPAR)

2021 ◽  
Author(s):  
Alla Ishchenko ◽  
Johan Joly ◽  
Neerinckx Barbara ◽  
Rik Lories ◽  
Kurt de Vlam
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Prospective Cohort ◽  
Biological Treatment ◽  
Structural Damage ◽  
Clinical Manifestations ◽  
Tender Joint Count ◽  
Tnf Inhibitor ◽  
Disease Characteristics ◽  
Over Time

Abstract Objectives Biological treatments revolutionized the management of psoriatic arthritis (PsA) by significantly improving clinical manifestations and preventing structural damage. Both result in better quality of life and improved physical functioning. Since the introduction of the first TNF inhibitor (TNFi) in the early 2000s, therapeutic options for PsA are increasing steadily and a new generation of biologicals, including anti interleukin (IL)-17 and anti IL23 strategies, allows distinct targeted approaches. The purpose of this study was to investigate whether the demographic, clinical and disease characteristics of PsA patients that are selected for first-line biological treatment, changed over time since the introduction of biologicals. Methods Patients with a clinical diagnosis of PsA were included in the KU Leuven BioSPAR registry, a prospective cohort of spondyloarthritis (SpA) and PsA patients treated with biologicals and targeted synthetic disease modifying anti-rheumatic drugs (tsDMARDs) such as apremilast and JAK inhibitors. Demographics, prior DMARD use, disease characteristics and disease activity parameters were recorded at the initiation of biological treatment and subsequently every 3-months for the first 2 years and later every 6 months. The patient data were compared in three treatment periods, corresponding with availability of the first and the second generation of TNF inhibitors and the third generation of biologicals. Results Analysis of 185 Caucasian patients with PsA from our prospective cohort showed longer disease duration and higher disease activity with higher tender joint count (TJC), swollen joint count (SJC) and higher CRP in the first as compared with the later time periods. The demographic characteristics and prior DMARD use did not change over time. Skin and nail psoriasis were more frequent in earlier compared with the later treatment periods. The bio-DMARD survival rate was similar in the early and later treatment periods. Conclusion The population of patients, selected for treatment escalation, changed over time since the introduction of biologicals. Our results suggest that with years of experience, PsA patients might be considered earlier and for therapy intensification in patients with less active disease as compared with profiles in the early days of biological treatment.

scholarly journals Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e032552 ◽  
Author(s):  
Bernd Schweikert ◽  
Chiara Malmberg ◽  
Mercedes Núñez ◽  
Tatiana Dilla ◽  
Christophe Sapin ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Cost Effectiveness ◽  
Maintenance Therapy ◽  
Induction Period ◽  
Severity Index ◽  
Cost Effectiveness Analysis ◽  
Severe Psoriasis ◽  
Base Case ◽  
Psoriasis Area Severity Index ◽  
Effectiveness Analysis

ObjectiveTo conduct a cost-effectiveness analysis from the perspective of the Spanish National Health System (NHS) comparing ixekizumab versus secukinumab.DesignA Markov model with a lifetime horizon and monthly cycles was developed based on the York model. Four health states were included: a biological disease-modifying antirheumatic drug (bDMARD) induction period of 12 or 16 weeks, maintenance therapy, best supportive care (BSC) and death. Treatment response was assessed based on both Psoriatic Arthritis Response Criteria (PsARC) and ≥90% improvement in the Psoriasis Area Severity Index score (PASI90). At the end of the induction period, responders transitioned to maintenance therapy. Non-responders and patients who discontinued maintenance therapy transitioned to BSC. Clinical efficacy data were derived from a network meta-analysis. Health utilities were generated by applying a regression analysis to Psoriasis Area Severity Index and Health Assessment Questionnaire‒Disability Index scores collected in the ixekizumab SPIRIT studies. Results were subject to extensive sensitivity and scenario analysis.SettingSpanish NHS.ParticipantsA hypothetical cohort of bDMARD-naïve patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis was modelled.InterventionsIxekizumab and secukinumab.ResultsIxekizumab performed favourably over secukinumab in the base-case analysis, although cost savings and quality-adjusted life-year (QALY) gains were modest. Total costs were €153 901 compared with €156 559 for secukinumab (difference −€2658). Total QALYs were 9.175 vs 9.082 (difference 0.093). Base-case results were most sensitive to the annual bDMARD discontinuation rate and the modification of PsARC and PASI90 response to ixekizumab or secukinumab.ConclusionIxekizumab provided more QALYs at a lower cost than secukinumab, with differences being on a relatively small scale. Sensitivity analysis showed that base-case results were generally robust to changes in most input parameters.Trial registration numberSPIRIT-P1: NCT01695239; Post-results, SPIRIT-P2: NCT02349295; Post-results.

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