Rheumatology (Bulgaria)

Leflunomide in Rheumatoid Arthritis: Factors associated with therapeutic maintenance

2024-06-13T19:19:33+03:00

Introduction Leflunomide is an immunomodulator indicated for the treatment of rheumatoid arthritis (RA). Its advent coincided with the arrival of biologics, limiting the scientific community's interest in analyzing its efficacy. Our study aimed to evaluate the therapeutic maintenance of leflunomide during the treatment of RA and to analyze the possible associated factors. Methods We conducted a single-center retrospective study at a rheumatology department, including all patients with RA, according to ACR/EULAR criteria, who received leflunomide for one month and more. RA activity parameters and adverse events were collected. Results We collected 73 patients divided into 70 women and three men. The average age at the time of introduction of leflunomide was 49.77 years [23-73]. The mean duration of treatment was 12.45±11.75 months. The rate of leflunomide maintenance was 96%, 73%, 27%, 15%, 10% and 4% at three months, six months, twelve months, eighteen months, 24 months, 36 months and 48 months respectively. The incidence rate for leflunomide discontinuation was 109 per 100 patient-years with a 95% confidence interval of 101 to 116 per 100 patient-years. Reasons for discontinuation of leflunomide were mainly the occurrence of adverse events (52%) and ineffectiveness of treatment (42%). In multivariate analysis, factors associated with leflunomide maintenance were: age less than 50 years (p=0.027; HR= 1.806; 95% CI [1.071; 3.048]) and use of systemic corticosteroids at leflunomide initiation (p=0.001; HR=2.713; 95% CI [1.480; 4.978]). Conclusion Our study confirms the efficacy of leflunomide prescribed in RA. A strict control of patients is recommended to avoid adverse events leading to drug discontinuation.

Rheumatoid arthritis associated to fibromyalgia: factors associated with active synovitis and a proposal of an algorithm for management

2024-06-13T19:19:33+03:00

Introduction: Recent studies have shown that ultrasound (US) assessment of disease activity in rheumatoid arthritis (RA) with associated fibromyalgia (FM) before disease-modifying antirheumatic drug escalation is primordial. The goal of this study was to assess the correlation between clinical and US disease activity in RA patients with concomitant FM comparatively to RA patients without FM. Specifically, we aimed to identify the predictive factors of detection of active US-synovitis. Methods: We conducted a cross-sectional study that included patients with diagnosis of RA (ACR/EULAR 2010 criteria) with and without concomitant FM (ACR 2016). US-detected synovitis was defined and scored 0-3 using the OMERACT scoring system at the joint level for both grey-scale (GS) and Doppler power (DP). Multiple linear regression analysis performed, adjusting for clinical and demographic variables. Results: Eighty patients distributed into 40 patients in each group were recruited. No significant difference was observed between the groups in regards to mean DAS28 and the three-variables (DAS28 V3). Multiple linear regression showed that in RA+FM group US synovitis detection was positively associated with male gender (B=0.29, p=0.04) and with the DAS28 V3 (B=0.87, p=0.014), and negatively associated with the patient global assessment (PGA) (B=-0.49, p=0.004). Doppler activity was positively associated with the DAS28 V3 (B=0.51,p=0.002) and with the physician global assessment (B=0.55, p=0.02), negatively associated with the PGA (B=-0.65, p=0.005). Conclusion: Our study showed that a high DAS28 V3 seems to be significantly associated with active US-synovitis in RA patients with comorbid FM.

Retention rate of upadacitinib therapy in rheumatoid arthritis: Results of a large italian multicenter real-world study

2024-06-19T21:27:00+03:00

Introduction: Upadacitinib (UPA) is an oral Janus kinase inhibitor (JAKi) recently approved for the treatment rheumatoid arthritis (RA) treatment. Although registrational studies have demonstrated the efficacy of UPA in RA, data on the long-term retention rate of this drug are still lacking. Objective: The objective of his study was to evaluate the real-world retention rate of UPA in patients with RA, analyze possible reasons for treatment discontinuation, and attempt to identify independent factors possibly associated with persistence of UPA treatment Methods: We conducted a multicenter retrospective observational study of patients with RA referred to tertiary rheumatology hospitals in Italy. One-hundred-eleven consecutive patients who received UPA in different lines of treatment were enrolled. Clinical history, previous treatments, and RA disease activity at baseline were recorded. The retention rate of UPA was assessed by Kaplan-Meier curve study. Cox proportional regression analysis was also performed to study the effect of independent factors on UPA therapy retention rate including age, sex, smoking habit, presence of anti-citrullinated protein antibody (ACPA)/rheumatoid factor (RF), disease duration, disease activity, line of treatment and concomitant treatments. Results: Analysis of demographic data revealed an M:F ration of 28:83, a median age of 58 years with an interquartile Range (IQR) of 50-65 years, and a median disease duration 78 months (IQR: 40-167) . The median observation period was 6.0 months (IQR 3.2-10.0). Most patients were on monotherapy or receiving concomitant steroids (55.0% and 58.6%, respectively). The UPA retention rate at 6 and 12 months was 90.4% and 74.7%, respectively. Reasons for treatment discontinuation included lack of efficacy (8/19), lost of efficacy (6/19) infections (3/19) and cancer onset (2/19). Other factors affecting the rate of UPA maintenance were duration of illness and RA seropositivity. Conclusion: The high retention rate of UPA indirectly suggests the good efficacy and acceptable safety profile of this drug in RA therapy. From our study data, we conclude that UPA could be an appropriate choice in most patients with RA, even after failure of previous lines of treatment. We also found that the drug had a higher retention rate in patients with seropositive RA than in their seronegative counterparts.

BIOSIMILAR MEDICINAL PRODUCTS – LEGISLATIVE DECISIONS AND MARKET ENTRY

2024-11-09T15:37:42+02:00

Biosimilar drugs, structurally identical and manufactured similarly to original biologic drugs, offer potential cost reductions in therapeutic practice, albeit with variations in adoption across European countries. This review synthesizes findings from literature examining legislative decisions and their effects on biosimilar market entry in Europe. Drawing from scientific articles and official documents, the review reveals that biologics constitute 36% of European drug expenditure, with the market valued at €78.6 billion in 2021 and growing annually at 10.5% over the past five years. Approximately 15% of new active substances centrally approved by the EMA in 2020 were biologics.

The European biosimilars market is projected to reach €8.8 billion in 2021. Various measures are being implemented to boost biosimilar uptake, including pricing strategies, reimbursement policies, and substitution practices. Access, measured in terms of availability and time to entry, is still difficult in a number of countries, but legislative measures are helping biosimilars enter European markets more quickly.