Evaluation of Use of Belimumab In Clinical Practice Settings (Observe Study) In Spain: Health Resource Utilization and Labour Absenteeism

Abstract

patients presented an overall clinical improvement of ≥ 20%, ≥ 50% and ≥ 80%. These improvements were associated with a reduction of steroid use (75% of patients on steroids at belimumab-initiation decreased mean dose from 14.8 to 6.8mg/day; p< 0.001) and HRU between the pre/post index periods: emergency-room visits 1.65 to 0.41; p= 0.001; unscheduled visits to treating-physician 1.02 to 0.03; p< 0.001, visits to other specialists (1.64 to 1.06; p= 0.017) and antibody tests (7.78 to 7.53; p= 0.47). An increase in HRU was observed for hematological and renal tests (3.14 to 3.52; p= 0.045) and (5.95 to 6.59; p= 0.024), respectively. Working patients (39%) also showed a reduction in the LA days between the pre/post index periods (25.6 to 5.7 days; p= 0.025). ConClusions: Belimumab treatment yielded improved clinical outcomes and a reduction in HRU directly related with SLE management, as corticoid use. Mean number of LA days also showed a substantial reduction, especially important in SLE, mostly affecting young patients.

Effectiveness, Tolerability, and Safety of Belimumab in Patients with Refractory SLE: a Review of Observational Clinical-Practice-Based Studies

“…The data collection was either purely retrospective [ 25 – 27 ] or a combination of a retrospective and a prospective phase [ 24 ]. The most common reasons for initiating belimumab therapy were ineffectiveness of patient’s previous treatment regimen (69.2–88% of patients, depending on the country), worsening of the patient’s condition (50–61%), and need to decrease corticosteroid drugs (40–67.3%).…”

“…OBSErve Spain [ 25 ] was a multicenter retrospective medical chart-review study that included 64 patients (Table 1 ). The overall clinical improvement at month 6 was ≥ 80, ≥ 50, and ≥ 20% in 27, 52, and 72% of patients, respectively; corticosteroid mean daily dose decreased from 14.8 to 6.8 mg ( p < 0.001).…”

“…Furthermore, the quantification of clinical response was a non-standardized, subjective tool that has not been validated. Another limitation is in the inclusion criteria as USA, Spain, and Canada OBSErve studies required at least 6 months of treatment (≥ 8 doses) [ 24 , 25 , 27 ]. This strongly biases the study population in favor of those who well tolerated and responded to belimumab treatment, or were treated by physicians who were compliant with regular patient follow-up.…”

Effects of Belimumab on Flare Rate and Expected Damage Progression in Patients With Active Systemic Lupus Erythematosus

“…Few data on effectiveness and safety of belimumab in daily clinical practice are available to date; they include some case reports , 2 case series that consisted of 18 and 20 patients with a maximum followup of 9 months , 1 observational study in 195 patients followed for 6 months , and the Observe (Evaluation of Use of Belimumab in Clinical Practice Settings) studies, most of them published as abstracts . Our aim was to evaluate the effectiveness and safety of belimumab in a group of SLE patients prospectively followed in 2 Italian referral centers.…”

When to use belimumab in SLE

“…Nevertheless, improvement in disease activity was judged relevant by all physicians involved, even though clinical manifestations were not dissected in detail. Interestingly, by improving control of disease activity belimumab was shown to reduce work disability, being thus cost-effective both in terms of employment and in decreasing health resource utilization and emergency room visits [11,12], and to ameliorate fatigue as well, which is among the major complaints of SLE patients [6,9,10,13,14].…”