Objective. To compare the efficacy of infliximab (IFX) versus adalimumab (ADA) as a first-line biologic drug over 1 year of treatment in a large series of patients with refractory uveitis due to Behçet's disease (BD).Methods.We conducted an open-label multicenter study of IFX versus ADA for BD-related uveitis refractory to conventional nonbiologic treatment. IFX or ADA was chosen as the first-line biologic agent based on physician and patient agreement. Patients received 3-5 mg/kg intravenous IFX at 0, 2, and 6 weeks and every 4-8 weeks thereafter, or 40 mg subcutaneous ADA every other week without a loading dose. Ocular parameters were compared between the 2 groups.Results. The study included 177 patients (316 affected eyes), of whom 103 received IFX and 74 received ADA. There were no significant baseline differences between treatment groups in main demographic features, previous therapy, or ocular sign severity. After 1 year of therapy, we observed an improvement in all ocular parameters in both groups. However, patients receiving ADA had significantly better outcomes in some parameters, including improvement in anterior chamber inflammation (92.31% versus 78.18% for IFX; P = 0.06), improvement in vitritis (93.33% versus 78.95% for IFX; P = 0.04), and best-corrected visual acuity (mean ± SD 0.81 ± 0.26 versus 0.67 ± 0.34 for IFX; P = 0.001). A nonsignificant difference was seen for macular thickness (mean ± SD 250.62 ± 36.85 for ADA versus 264.89 ± 59.74 for IFX; P = 0.15), and improvement in retinal vasculitis was similar between the 2 groups (95% for ADA versus 97% for IFX; P = 0.28). The drug retention rate was higher in the ADA group (95.24% versus 84.95% for IFX; P = 0.042).Conclusion. Although both IFX and ADA are efficacious in refractory BD-related uveitis, ADA appears to be associated with better outcomes than IFX after 1 year of follow-up. 9 Manuel Díaz-Llopis, MD, PhD, ATIENZA-MATEOETAL | PATIENTS AND METHODS Study design, enrollment criteria, and definitions.We conducted an observational, open-label multicenter study including 177 patients with refractory uveitis due to BD who were treated with IFX or ADA as first-line biologic therapy. The dosing schedule was as follows: for IFX, 3-5 mg/kg intravenously (IV) at
BackgroundLack of adherence to medication in rheumatoid arthritis (RA) can worsen disease activity, but data on adherence to biological drugs is scarce.ObjectivesTo evaluate RA patients adherence to the subcutaneous (SC) biological treatment prescribed by the physician during the first year of treatment.MethodsRetrospective study in RA patients ≥18 years-old from 42 Spanish hospitals, which had been prescribed a SC biological drug 12 to 18 months prior to the study visit. Data were collected from patients' clinical records and hospital pharmacy drug-dispensing logs. Adherence was evaluated through the Medication Possession Ratio (MPR) (actual number of days covered by the taken medication/theoretical number of days covered by the prescribed medication). The number of days theoretically covered was calculated considering the interval of administration of the prescribed biological drug, if induction dose was prescribed, and if there were suspension periods or changes in the dose. The actual number of days covered was calculated with the number of vials that the patient had taken from the hospital pharmacy during the study period. Non-adherence was diagnosed if MPR was ≤80%.Results364 patients were included (age 54.9 years [12.5]; 77.5% women, median RA duration 7.8 years). The initial interval of administration of the biological drug was weekly (44.2%), biweekly (39.1%) and monthly (17.3%); the median duration of the period studied was 14.8 months. For the primary analysis, 363 patients were valid, of which 52 patients were non-adherent (MPR ≤80%) to the prescribed schedule (14.3%; 95% CI: 11.1–18.3). There were no differences in adherence by age ranges, gender or other socio-demographic factors, such as level of education, smoking habit or alcohol intake, employment status, comorbidities or polypharmacy (all, p= NS). Non-adherence was less frequent in patients with a monthly administration schedule (6.4%) than in patients with a weekly (17.4%, p=0.034) or biweekly administration (14.4%, p=0.102), and slightly more frequent in those receiving induction (21.6% vs 12.5% without induction, p=0.068). No differences were observed between patients who used syringes or pen devices, or in patients who had periods of treatment interruption.ConclusionsIn RA patients, 14.3% were non-adherent to the prescribed SC biological medication during the first year of treatment, with no differences related to socio-demographic variables. Adherence was higher in those patients with monthly subcutaneous administration.AcknowledgementThe ARCO study was funded by Merck Sharp & Dohme of Spain.Disclosure of InterestNone declared
Objective In a large series of Caucasian patients with refractory uveitis due to Behçet disease (BD) treated with infliximab (IFX) we assessed: a) long-term efficacy and safety and b) IFX optimization when ocular remission was achieved. Methods Multicenter study of IFX-treated patients with BD uveitis refractory to conventional immunosuppressant agents.103 patients/185 affected eyes were treated with IFX as first biologic therapy as follows: 3-5 mg/kg i.v. at 0, 2, 6 and then every 4-8 weeks. a) The main outcome variables were analyzed at baseline, 1st week, 1st and 6th months and 1st and 2nd years of IFX therapy. b) After remission, based on a shared decision between patient and clinician, IFX optimization was performed. Efficacy, safety, and cost of IFX therapy were evaluated. Results In whole series (n=103), main outcome variables showed a rapid and maintained improvement, reaching remission in 78 patients after a mean IFX duration of 31.5 months. Serious adverse events were observed in 9 patients: infusional reactions (n=4), tuberculosis (n=1), Mycobacterium avium pneumonia (n=1), severe oral ulcers (n=1), palmoplantar psoriasis (n=1) and colon carcinoma (n=1). In the optimization subanalysis, the comparative study between optimized and nonoptimized groups showed: a) no differences in clinical characteristics at baseline; b) similar maintained improvement in most ocular outcomes; and c) lower severe adverse events, and d) lower mean IFX costs in optimized group (4,826.52 vs. 9,854.13 euros/patient/year). Conclusion IFX seems to be effective and relatively safe in Caucasian patients with refractory BD uveitis. IFX optimization is effective, safe, and cost-effective.
Behçet's disease (BD) is a systemic vasculitic disorder of unknown aetiology characterised by recurrent oral and often genital ulcers, which may be associated with ocular, cutaneous, articular, neurological or vascular involvement. We report a 52-year-old woman diagnosed of neuro-BD who was treated with infliximab with a dramatic response to this treatment.
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