AB0848 IS THERE A WINDOW OF OPPORTUNITY IN EARLY PSORIATIC ARTHRITIS? RETROSPECTIVE DATA FROM A REAL LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1731-1731
Author(s):  
S. G. Werner ◽  
M. Vlachou ◽  
H. E. Langer ◽  
R. Chatelain

Background:In early rheumatoid arthritis (ERA) a window of opportunity (WoO) is well established since its first proposal in 2002 (1). ERA patients achieved a better clinical outcome when DMARD therapy was initiated within the first 12-16 weeks after start of symptoms (disease duration (Xd) (2). To the best of our knowledge, comparable data are missing for early psoriatic arthritis (EPsA), even though the benefit of tight control is known in EPsA (3,4). In contrast to ERA early PsA is usually defined as Xd <24months (3,4).Objectives:To study in a setting of routine rheumatologic care if a WoO like in ERA also can be observed in EPsA comparable to ERA.Methods:n=90 consecutive outpatients with definite PsA were recruited in this retrospective longitudinal cohort study with the following inclusion criteria: DMARD- and steroid-naïve at the first time of visit in our outpatient clinic (t0), minimum follow-up of 3 years, classification as very early psoriatic arthritis (VEPsA, Xd≤3 months, n=30), late early psoriatic arthritis (LEPsA, > 3 Xd ≤ 12 months, n=30) and late psoriatic arthritis (LAPsA, Xd > 36 months, n=30). Standardized assessments had been performed at regular intervals of 3 months within the framework of routine rheumatologic care. Outcome at 3 years (t36) was analyzed within groups and between groups (DAS28, Physician Global Assessment (PhG), HAQ, fatigue, morning stiffness).Results:Cohorts did not differ between gender and age (mean age 54 years). There was no significant difference in DAS28, HAQ, PhG and morning stiffness at t0. Fatigue at t0 differed between cohort 1 and 3 significantly (p<0.03). In all cohorts DAS28 and PhG have been decreased at t36 significantly (minimal p< 0.006). In comparison to VEPsA LEPsA showed a significant difference in DAS28 (p<0.04) and PhG (p<0.05), but not in morning stiffness and fatigue. Highly significant differences between VEPsA and LAPsA were observed for DAS28 (p <0.007), morning stiffness (p < 0.001), PhG (p<0.05) and fatigue (p < 0.006) at t36.Conclusion:Significant and relevant differences between the outcomes at 3 years of patients with VEPsA, LEPsA and LAPsA could be identified in this retrospective pilot study. Particularly the highly significant difference between VEPsA and LAPsA (<3 months vs. >36months) is remarkable. The data suggest a window of opportunity also in patients with EPsA. With a time interval of Xd≤12 this window seems to be longer than in ERA. Further studies with higher number of patients were needed to confirm our findings from this real life setting.References:[1]O´Dell JR Treating Rheumatoid Arthritis Early: A Window of Opportunity? Arthritis Rheum 2002;46:283–285[2]Nell VPK, Machold KP, Eberl G, Stamm TA, Uffmann M, Smolen JS Rheumatology 2004 43:906-914[3]Coates LC, Moverley AR, McParland Let al. Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial.Lancet2015,386:2489–98.[4]Coates LC, Mahmood F, Freeston J, Emery P, Conaghan PG, Helliwell PS Long-term follow-up of patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial Rheumatology (Oxford) 2019 kez369Disclosure of Interests:None declared

2019 ◽  
Vol 10 ◽  
Author(s):  
Mayara Costa de Camargo ◽  
Bruna Cipriano Almeida Barros ◽  
Izabela Fulone ◽  
Marcus Tolentino Silva ◽  
Miriam Sanches do Nascimento Silveira ◽  
...  

Rheumatology ◽  
2021 ◽  
Author(s):  
Janne Heuvelmans ◽  
Nathan den Broeder ◽  
Geke A H van den Elsen ◽  
Alfons A den Broeder ◽  
Bart J F van den Bemt

Abstract Objectives The aim of this study was to compare the effectiveness and tolerability between oral methotrexate (MTX) and subcutaneous MTX in a large group of rheumatoid arthritis (RA) patients in a real-life setting. Methods In this retrospective cohort study, adult patients with clinical diagnosis of RA who started MTX treatment (monotherapy or combined with hydroxychloroquine), either started with oral or subcutaneous MTX. The primary outcome was superiority testing of between group difference in change in DAS28CRP between baseline and 3–6 months, and subsequent non inferiority testing (NI margin 0.6) analyses in case of non-superiority. Secondary outcomes included MTX dose, side effects, laboratory abnormalities, and use of comedication. Results 640 RA patients were included: 259 started with oral MTX and 381 with subcutaneous. There was no significant difference in ΔDAS28CRP, after adjusting for confounding, 0.13 (95%-CI: -0.14, 0.40), and oral MTX strategy was non inferior to subcutaneous. The mean MTX dose was slightly lower for the oral strategy (18.0 SD6.9 vs 19.9 SD8.2, p= 0.002), which was accompanied by a lower cumulative incidence of adverse events (41% vs 52%, p= 0.005). No differences were seen in use of other comedication. Conclusions Starting with oral MTX in RA in a real-life setting is non inferior to a subcutaneous MTX treatment with regard to disease activity control, at least when used in dosages up to 25 mg and on a background of HCQ cotreatment and a treat-to-target approach. In addition, tolerability was better. This supports the strategy of starting with oral MTX.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 722.1-723
Author(s):  
E. G. Favalli ◽  
A. Marchesoni ◽  
S. Balduzzi ◽  
C. Montecucco ◽  
C. Lomater ◽  
...  

Background:Observational data on the use of secukinumab for the treatment of spondyloarthritides are still lacking. Large population-based registries that allow long-term follow-up have been increasingly used to investigate the performance of biologic drugs in a real life setting.Objectives:The aim of this study is to evaluate the effectiveness and the retention rate of secukinumab in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients in a real-life setting over a 3-year follow-up period.Methods:Data of all PsA and axSpA patients (diagnosed according to CASPAR and ASAS criteria, respectively) treated with secukinumab were prospectively collected in the Italian multicentric LORHEN registry. Effectiveness was measured as the mean change from baseline of Disease Activity in PSoriatic Arthritis score (DAPSA) in PsA and Ankylosing Spondylitis Disease Activity Score (ASDAS) in axSpA patients. Rates of DAPSA remission and ASDAS inactive disease were also computed. The 3-year retention rate was calculated by the Kaplan-Meier method and compared between PsA and axSpA by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 195 PsA (55.4% females, mean age 50.7 [±11.8] years, mean disease duration 10 [±7.8] years, mean baseline DAPSA 23.12 [±12.3]) and 94 axSpA (61.7% males, mean age 49.1 [±12.7] years, mean disease duration 10.4 [±9.4] years, mean baseline ASDAS 3.41 [±1.1]) patients who received secukinumab as first (26.5 and 33%, respectively) or subsequent biologic agent. Compared with baseline, the 3-, 6- and 12-month mean values of both DAPSA (12.6 [±9], 11.2 [±10.5] and 9.3 [±7.5], respectively) and ASDAS (2.23 [±0.9], 2.15 [±0.9], and 1.84 [±0.9], respectively) were significantly decreased (p<0.001 for all the timepoints). The 3-, 6-, and 12-month rates of remission/inactive disease were 15.5, 25.4, and 30.5% in PsA and 18, 23.7, and 28.6% in axSpA group, respectively. One- and 3-year retention rate (figure 1) were respectively 79.4% and 66.6% in PsA and 72.3% and 70.1% in axSpA patients, with no significant difference between the two groups (p=0.517). The most frequent reason for withdrawal was inefficacy in both PsA (n=41) and axSpA (n=20), whereas only 8 PsA and 6 axSpA patients discontinued secukinumab because of adverse events.Conclusion:Our data confirmed in a real-life setting the 1-year clinical efficacy and the 3-year survival of secukinumab in both PsA and axSpA. The safety profile of secukinumab was very favorable for both the indications. No significant differences were observed in the performance of secukinumab between ax-SpA and PsA.References:[1]Deodhar A, et al. Arthritis Research & Therapy; 2019.[2]Mease PJ, et al. RMD Open. BMJ Specialist Journals; 2018;4(2):e000723.[3]Baraliakos X, et al. Clin Exp Rheumatol. 2018 Jan;36(1):50–5.Disclosure of Interests:Ennio Giulio Favalli Consultant of: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Speakers bureau: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Antonio Marchesoni Speakers bureau: Abbvie, Pfizer, UCB, Novartis, Celgene, Eli Lilly, Silvia Balduzzi: None declared, Carlomaurizio Montecucco: None declared, Claudia Lomater Consultant of: Advisory board for Sanofi, Novartis, Abbvie, Gloria Crepaldi Consultant of: Advisory board for Sanofi and Celgene, Speakers bureau: BMS, MSD, Silvia Talamini: None declared, Chiara Bazzani: None declared, Enrico Fusaro: None declared, Marta Priora: None declared, Aurora Iannello: None declared, Giuseppe Paolazzi: None declared, Roberto Caporali Consultant of: AbbVie; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme; Celgene; Bristol-Myers Squibb; Pfizer; UCB, Speakers bureau: Abbvie; Bristol-Myers Squibb; Celgene; Lilly; Gilead Sciences, Inc; MSD; Pfizer; Roche; UCB


2021 ◽  
Vol 8 ◽  
Author(s):  
Vandana Bhushan ◽  
Susan Lester ◽  
Liz Briggs ◽  
Raif Hijjawi ◽  
E. Michael Shanahan ◽  
...  

Aims: To determine real-life biologic/targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) retention rates in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), explore reasons for switching and to compare results to previously published data.Methods: Time-to-event analysis for mean treatment duration (estimated as the Restricted Mean Survival Time), b/tsDMARD failure, and b/tsDMARDs switching was performed for 230 patients (n = 147 RA, 46 PsA, 37 AS) who commenced their first b/tsDMARD between 2008 and 2018. Patients were managed in a dedicated “biologics” clinic in a tertiary hospital; the choice of b/tsDMARD was clinician driven based on medical factors and patient preferences. The effect of covariates on switching risk was analysed by a conditional risk-set Cox proportional-hazards model. Treatment retention data was compared to a historical analysis (2002–2008).Results: The proportions remaining on treatment (retention) were similar, throughout follow-up, for the first, second and third b/tsDMARDs across all patients (p = 0.46). When compared to RA patients, the risk of b/tsDMARD failure was halved in PsA patients [Hazard Ratio (HR) = 0.50], but no different in AS patients (HR = 1.0). The respective restricted mean (95%CI) treatment durations, estimated at 5 years of follow-up, were 3.1 (2.9, 3.4), 4.1 (3.7, 4.6), and 3.3 (2.8, 3.9) years, for RA, PsA, and AS, respectively. Age, gender, disease duration, smoking status and the use of concomitant csDMARDS were not associated with the risk of bDMARD failure. The most common reasons for switching in the first and subsequent years were secondary (n = 62) and primary (n = 35) failure. Comparison with historical data indicated no substantive differences in switching of the first biologic for RA and PsA.Conclusion: Similar retention rates of the second and third compared to the first b/tsDMARD in RA, PsA, and AS support a strategy of differential b/tsDMARDs use informed by patient presentation. Despite greater availability of b/tsDMARDs with differing mechanisms of action, retention rates of the first b/tsDMARD remain similar to previous years.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1438.2-1438
Author(s):  
V. Boyadzhieva ◽  
N. Stoilov ◽  
E. Kurteva ◽  
R. Stoilov

Background:Assessment of disease activity and quality of life are one of the main indicators for determining the effectiveness of treatment with disease-modifying antirheumatic drugs. In recent years, a new group has entered the market - target synthetic DMARDS, which prove their effectiveness in treating RA comparable to that of biological products.Objectives:The aim of this study is to evaluate the disease activity and quality of life of patients with rheumatoid arthritis (RA) treated with biological agents in comparison with Tofacitinib (real life data from Bulgarian population) and determine whether or not the benefits of different therapies were sustained over a follow up period of 1 year.Methods:164 patients were selected with a mean age 55.34 ± 16SD years, meeting the 1987 ACR and /or ACR/ EULAR (2010) classification criteria for Rheumatoid arthritis (RA). Patients were arranged according to treatment regimens: Tocilizumab (TCL) 30 patients, Certolizumab (CZP) 16, Golimumab (GOL) 22, Etanercept (ETN) 20, Adalimumab (ADA) 20, Rituximab (RTX) 16, Infliximab (INF) 20, Tofacitinib (TOF) 20. Disease activity and quality of life was the primary concern. Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month’s thereafter. CRP was used to measure the inflammatory process.DAS28-CRP, clinical disease activity index (CDAI) and simplified disease activity index (SDAI)were calculated. On baseline all of the patients’ groups had severe disease activity (mean DAS28-CRP > 5.2, mean CDAI > 22, mean SDAI > 26. The quality of life was evaluated via EQ-5D.All of the patients were on stable therapy according to the inclusion criteria, and didn’t interrupt any of the medications including biological or target synthetic treatment.Results:Significant clinical improvement and statistically significant reduction in disease activity were observed in patients treated with bDMARDS and tsDMARDS within 6 months (p <0.005) of treatment and after 12 months of follow-up (p=0.039). The mean value of DAS28-CRP after one year follow up showed an non-inferior effect of Tofacitnib (3.04± 0.81) in comparison to biological treatment (TCL: 3.07 ± 0.73; CZP: 3.06 ± 0.65; GOL: 2.49 ± 0.76; ETN: 2.85 ± 0.55; ADA: 3.15 ± 0.82; RTX: 2.90 ± 0.70; INF: 3.14; ± 0.61; TOF: 3.04± 0.81). An improvement was also observed for the 6 to 12 months of follow-up as we did not detect a significant difference in the activity of the disease assessed by CDAI among the different drug groups.The mean values showing the change of the SDAI over the study period also outline comparable profiles. All of the treatment groups achieved a rapid reduction in disease activity that continued to decrease through the 6 and 12 months period, respectively, as supported by changes in SDAI.The quality of life evaluated with EQ-5D revealed significant improvement on the 6-th month of follow up as well as after 12th month (p<0.005) without significant difference between the observed groups.Conclusion:Real-life data show that patients on biological treatment as well as those on Tofacitinib therapy achieve a significant decrease in disease activity after one year of follow-up. This gives us reason to accept the importance of non-inferior effect of jak-inhibitors and their place in treatment of Rheumatoid arthritis.Disclosure of Interests:Vladimira Boyadzhieva: None declared, Nikolay Stoilov: None declared, Ekaterina Kurteva: None declared, Rumen Stoilov Grant/research support from: R-Pharm


2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Belén Serrano-Benavente ◽  
Larissa Valor ◽  
Tamara del Río Blasco ◽  
Iustina Janta ◽  
Roberto González Benítez ◽  
...  

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 872.1-872
Author(s):  
F. Ingegnoli ◽  
A. F. Luppino ◽  
G. Cincinelli ◽  
E. Favalli ◽  
R. Caporali

Background:Despite significant improvement in the RA management, up to twenty percent of patients with rheumatoid arthritis (RA) have a difficult-to-treat (D2T) disease. The COVID-19 related mitigation policies, for instance quarantine, and consequent difficult access to in-person visits, laboratory and imaging investigations, adversely affected the follow up of rheumatic patients. Although pandemic-imposed limitations could have negatively influenced disease management particularly in D2T patients, to what degree these restrictions affected the treat-to target (T2T) and tight-control strategy in this subgroup of RA patients has not been investigated yet.Objectives:To evaluate whether the switch to telehealth imposed by COVID-19 pandemic was effective in the management of D2T RA patients treated with targeted therapies.Methods:This observational retrospective real-life study was conducted from November 2019 through September 2020. Among RA patients treated with targeted therapies, RA D2T patients according to EULAR definition (1) were identified. Clinical Disease Activity Index (CDAI) of these patients was analysed retrospectively before, during and after lockdown (LD). During LD period, patients could choose whether to receive home drug delivery or to maintain their face-to-face consultations, and in the former rheumatologists provided virtual care. To evaluate the effect of LD on the percentage of patients in remission, logistic mixed effects regression models were fitted, with CDAI remission as response variable.Results:Data were extracted from a longitudinal observational registry, and at baseline, 52 patients treated with targeted therapies were classified as D2T RA. Among them, during pre-LD, LD, and post-LD 11.54% (N=6), 53.49% (N=23), and 46.15% (N=24) had CDAI remission/low disease activity, while 46 (88.46%), 20 (46.51%) and 28 (53.85%) had CDAI moderate/high. All the patients completed the follow-up. Median values of CDAI during pre-LD, LD, and post-LD were 14.5 [IQR 12-21], 9 [IQR 5.5-16], and 11 [IQR 6-19.2] respectively (see Figure 1 below).Conclusion:Telephone-based tight control strategy ensured satisfactory management of D2T RA treated with targeted therapies. This temporary approach has been a feasible compensation for the decline of face-to-face visits also in this challenging group of RA patients, thus reassuring for future months before the end of pandemic.References:[1]Nagy G, et al. EULAR definition of difficult-to-treat rheumatoid arthritis. Ann Rheum Dis 2021;80(1):31-35.Disclosure of Interests:Francesca Ingegnoli: None declared, Angela Flavia Luppino: None declared, Gilberto Cincinelli: None declared, Ennio Favalli Speakers bureau: AbbVie, Sanofi-Genzyme, Lilly, UCB, Pfizer, Novartis, Janssen, Paid instructor for: Roche, MSD, Consultant of: Lilly, Galapagos, Roberto Caporali Speakers bureau: Abbvie, Amgen, BMS, Celltrion, Galapagos, Gilead, Lilly, Pfizer, Roche, UCB, Sanofi, Fresenius Kabi, Samsung bioepis, MSD, Consultant of: Galapagos, Gilead, Lilly,Janssen, MSD.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 730.1-730
Author(s):  
M. Lorenzin ◽  
A. Carletto ◽  
R. Foti ◽  
M. S. Chimenti ◽  
A. Semeraro ◽  
...  

Background:Secukinumab (SEC) is a novel treatment for psoriatic arthritis (PsA),but data from real life are still missing.Objectives:1)to evaluate the effectiveness and safety of a wide cohort of PsA patients on SEC followed in 7 Italian rheumatologic centers for 24 months;2)to compare the features and disease activity indices of SEC-treated PsA patients subdivided in naïve biological drugs (group A) and in TNF-inhibitors (TNFi) failure patients (group B).Methods:Consecutive patients with moderate-severe PsA,who begun SEC treatment were evaluated prospectively.Data on disease characteristics,previous and ongoing treatments,comorbidities and duration of follow-up were collected.Disease activity,functional and clinimetric scores and biochemical values were recorded at baseline (t0),at 6 (t6),12 (t12),and 24 (t24) months.Anova (Kruskal Wallis) and generalized linear models were used to compare variables over time.Infections and adverse events were also collected.Results:PsA345patients [38.84% men;mean age 52.9 (11.27) years] were enrolled;mean treatment duration was 18.53 (9.97) years.SEC was prescribed as first line biologic treatment in 133 (38.55%) patients and as second or more line biological treatment in 212 (61.45%) patients. Enthesitis was present as a prominent manifestation in 61.44% of patients (Figure 1).In all population significant decrease in tender/swollen joints;Visual Analogue Scale of pain (VASp) and general health (VASgh);Psoriasis Area Severity Index (PASI);Leeds Enthesitis Index (LEI);number of dactylitis;Health Assessment Questionnaire modified for spondyloarthritis (HAQ-S);Bath Ankylosing Spondylitis Disease Activity Index (BASDAI);Bath Ankylosing Spondylitis Functional Index (BASFI);C-reactive protein (CRP) was achieved.Effectiveness of all PsA patients was associated to an improvement in Ankylosing Spondylitis disease activity score (ASDAS) [t0=3.45 (0.69) vs t24=1.48 (0.23);p<0.01] and in Disease Activity in PsA (DAPSA) [t0=29.52 (12.56) vs t24=11.41 (7.63);p<0.001].At t0group Bhad a more erosive (p=0.04) and polyarticular pattern (p=0.04),a longer disease duration (p=0.001),a greater prevalence (p=0.04) of psoriasis and dactylitis (p=0.01),a higher PASI score (p=0.01),while no significant difference was observed for uveitis,inflammatory bowel diseases,enthesitis.At t24group Ashowed better physical functioning and lower disease activity compared togroup B[HAQs A vs B=0.03 (0.16) vs 0.69 (0.73);BASDAI A vs B=2.37 (0.66) vs 4.27 (2.33);ASDAS A vs B=1.4 (0.62) vs 1.99 (0.86);CRP A vs B=2.03 (1.94) vs 3.11 (1.55) mg/L;DAPSA A vs B=7.03 (3.57) vs 12.41 (8.05)].After t24 of treatment 74.6% ofGroup Aand 72.8% ofGroup Barticular had an inactive\low disease activity (MDA),accordingly to ASDAS and DAPSA respectively.Forty-three patients (12.46%) stopped the treatment during the follow-up mainly because of primary or secondary loss of efficacy (29 and 24, respectively).Only 14 patients suspended SEC because of adverse events (of which 9 for reactions at site of injection).A low number of episodes of mild infections (16) occurred;SEC was instead permanently discontinued in 7 cases for:oral refractory mucositis (3);recurrent aphthosis (2);diverticulitis (2).The retention rate at t24 was good in the whole population.Interestingly no differences were found betweenGroup AandB(p=0.815).Conclusion:In a real life clinical setting,SEC was safe and effective in PsA. as shown by a significant decrease of DAPSA and ASDAS over a 24-months follow up.Disclosure of Interests:Mariagrazia Lorenzin: None declared, Antonio Carletto: None declared, Rosario Foti Consultant of: lilly, sanofi, MSD, Janssen, Abbvie, BMS, celgene, roche, Speakers bureau: lilly, sanofi, MSD, Janssen, Abbvie, BMS, celgene, roche, Maria Sole Chimenti: None declared, Angelo Semeraro: None declared, Luisa Costa: None declared, Leonardo Santo: None declared, Elena Fracassi: None declared, Ilaria Montanari: None declared, Mara Felicetti: None declared, Giulia Lavinia Fonti: None declared, Francesco Caso: None declared, Andrea Doria Consultant of: GSK, Pfizer, Abbvie, Novartis, Ely Lilly, Speakers bureau: UCB pharma, GSK, Pfizer, Janssen, Abbvie, Novartis, Ely Lilly, BMS, Augusta Ortolan: None declared, Roberta Ramonda Speakers bureau: Novartis, Celgene, Janssen, Pfizer, Abbvie, Lilly


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