scholarly journals Adverse Events in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Receiving Long-Term Biological Agents in a Real-Life Setting

2019 ◽  
Vol 10 ◽  
Author(s):  
Mayara Costa de Camargo ◽  
Bruna Cipriano Almeida Barros ◽  
Izabela Fulone ◽  
Marcus Tolentino Silva ◽  
Miriam Sanches do Nascimento Silveira ◽  
...  
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. 582.1-582
Author(s):  
E. G. Favalli ◽  
F. Iannone ◽  
E. Gremese ◽  
R. Gorla ◽  
R. Foti ◽  
...  

Background:Long-term observational data on the real-life use of JAK inhibitors (JAKis) for rheumatoid arthritis (RA) and their comparison with biological drugs are still very limited. Large population-based registries have been increasingly used to investigate the performance of targeted drugs in a real-life setting.Objectives:The aim of this study is to evaluate and compare the 3-year retention rate of JAKis, TNF inhibitors (TNFis) and biologic drugs with other mechanisms of action (OMAs) in the large cohort of RA patients included in the Italian national GISEA registry.Methods:Data of all RA patients treated with targeted synthetic or biologic drugs were prospectively collected in the Italian multicentric GISEA registry. The analysis was limited to patients who started a first- or second-line targeted drug in the period after the first JAKi was marketed in Italy (1st December 2017). The 3-year retention rate was calculated by the Kaplan-Meier method and compared between different drug classes by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 1027 RA patients (79.8% females, mean age [±SD] 56.9 [±13.5] years, mean disease duration 9.8 [±9] years, mean baseline SDAI 17.5 [±11.9], ACPA positive 67.4%, RF positive 62.7%) who received JAKis (baricitinib or tofacitinib, n=297), TNFis (n=365), or OMAs (n=365) as first or second targeted drug. Main baseline characteristics of study population were overall well balanced between treatment groups. Retention rate was numerically but not statistically higher (p=0.18) in patients treated with JAKis compared with TNFis or OMAs (80.6, 78.9 and 76.4% at 1 year and 73, 56.8 and 63.8% at 3 years, respectively) (Figure 1). Drug survival was significantly higher in patients receiving concomitant methotrexate (MTX) compared with monotherapy only in TNFis (66.8 vs 47.1%, p=0.04) but not in JAKis (76.1 vs 70.1%, p=0.54) and OMAs (66.1 vs 61.9%, p=0.41) group. Therapy was discontinued in a total of 211 patients because of ineffectiveness (n=107), adverse events (n=88), or compliance/other reasons (n=16). The most frequent reason for treatment withdrawal was ineffectiveness in both JAKis (n=30 out of 56) and TNFis (n=45 out of 74) groups, whereas OMAs were discontinued more frequently because of adverse events (n=41 out of 81).Conclusion:Our data confirmed in a real-life setting a favorable 3-year retention rate of all available targeted mechanisms of action for RA therapy. As expected, concomitant MTX significantly impacted persistence on therapy of TNFis only. Discontinuations of JAKis for adverse events were infrequent overall, confirming the safety profile observed in randomized clinical trials.Figure 1.Three-year retention rate by treatment groupDisclosure of Interests:None declared


Rheumatology ◽  
2014 ◽  
Vol 54 (7) ◽  
pp. 1170-1176 ◽  
Author(s):  
Maarit Tarkiainen ◽  
Pirjo Tynjälä ◽  
Paula Vähäsalo ◽  
Pekka Lahdenne

2014 ◽  
Vol 73 (Suppl 2) ◽  
pp. 1214.2-1214
Author(s):  
A. Palomino ◽  
V. Giraldo ◽  
G. Saavedra-Martinez ◽  
L. Villarreal ◽  
A. Tique ◽  
...  

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


2014 ◽  
Vol 73 (Suppl 2) ◽  
pp. 942.1-942
Author(s):  
A. Palomino ◽  
V. Giraldo ◽  
P. Santos-Moreno ◽  
G. Saavedra-Martinez ◽  
L. Villarreal ◽  
...  

Author(s):  
Maria Sole Chimenti ◽  
Paola Conigliaro ◽  
Francesco Caso ◽  
Luisa Costa ◽  
Augusta Ortolan ◽  
...  

Abstract Objectives To determine the effectiveness of golimumab (GLM) in improving joint, periarticular structures and cutaneous manifestations in patients with moderate to severe psoriatic arthritis (PsA) with cutaneous psoriasis in different real-life clinical settings and 48-month drug survival. Methods Clinical and laboratory records were collected from PsA patients treated with GLM at baseline (T0) and after 6, 12, 24, 36, and 48 months of treatment. Comparisons were performed using a paired t-test or Wilcoxon test. Drug survival rates were analyzed using Kaplan–Meier estimates. p value < 0.05 was considered statistically significant. Results Data from 105 patients were collected. PsO occurred in 80% of patients and enthesitis in 78%, peripheral and axial arthritis in 63.8% and 35.3%, respectively, while erosions in 36.2%. The main comorbidities were cardiovascular diseases (31.4%) and metabolic syndrome (MetS) (19%). A statistically significant improvement in articular and cutaneous psoriasis was registered at T48 of GLM-therapy in clinical (DAPSA p < 0.0001; PASI p < 0.01; BASDAI p < 0.0001) and laboratory (CRP < 0.05) indexes. Gender (p = 0.652), BMI (p = 0.655), smoking habit (p = 0.466), and line of treatment (p = 0.208) did not affect treatment efficacy nor persistence. At T48, 42% of patients discontinued GLM: the most frequent reason was an insufficient response or loss of efficacy (28.6%). Conclusion A 48-month GLM high drug persistence of PsA patients was observed in real-life, in patients presenting high disease activity, elevated prevalence of comorbidities, and more than one line of treatment at baseline. Patients’ characteristics as gender, smoke, BMI, different lines of treatment, and concomitant methotrexate treatment affected treatment persistence, making GLM effective and safe in moderate-severe PsA in a long-term real-life setting. Key Points• Golimumab was effective in psoriatic arthritis, including both musculoskeletal and cutaneous manifestations. • Golimumab effectiveness and drug survival were not affected by comorbidities and patient-related characteristics. • The 4-year drug survival curves confirm the efficacy and safety of golimumab in psoriatic arthritis patients in a real-life setting.


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