First Real-World Insights into Belimumab Use and Outcomes in Routine Clinical Care of Systemic Lupus Erythematosus in Germany: Results from the OBSErve Germany Study

Abstract

OBSErve Germany was the first observational study of belimumab as add-on treatment for systemic lupus erythematosus (SLE) in routine clinical care in Germany, retrospectively collecting data from 102 SLE patients, 6 months before and after belimumab initiation. Most patients had moderate or severe SLE and several SLE manifestations. After 6 months of belimumab treatment, 78% of patients showed an improvement in overall disease activity of at least 20% in their physician’s judgment and for 42% of patients the improvement was at least 50%. Similar results were observed for the most common manifestations: arthritis, fatigue, rash, alopecia, increased anti-dsDNA antibody levels, and low complement. The SLE Disease Activity Index (SLEDAI/SELENA-SLEDAI) decreased from 10.6 to 5.6 (n = 65), with other indices also showing improvement. A notable dose reduction was seen for concomitant oral corticosteroids, from 13.7 to 7.6 mg/day overall (n = 91), and from 17.5 to 8.6 mg/day in patients with a high corticosteroid dose at belimumab initiation (≥7.5 mg; n = 63). Six patients discontinued belimumab therapy within 6 months. Overall, belimumab showed promising results for SLE patients in real-world settings. After 6 months of belimumab treatment, disease activity and corticosteroid use were reduced. The discontinuation rate was low and belimumab appeared to be well tolerated. Funding GlaxoSmithKline UK.

Smoking and pre-existing organ damage reduce the efficacy of belimumab in systemic lupus erythematosus

“…In Paper IV, we investigated the clinical and serologic effects of belimumab treatment in 58 patients with SLE. In agreement with the RCTs of belimumab [201,202] and recent observational studies [469][470][471][472], we observed decreasing disease activity during follow-up, corresponding to changes greater than the minimal clinically important differences (MCIDs) proposed for SLEDAI-2K and SLAM-R [473] already at month three. In accordance with previous implications [474], we also found decreasing corticosteroid use, indicating steroidsparing effects of belimumab.…”

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

“…OBSErve Germany [ 26 ] evaluated the effect of belimumab in 102 patients (Table 1 ). Data were collected from patient medical records 6 months before and after belimumab initiation.…”

“…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. OBSErve Germany, on the contrary, minimized selection bias by including all eligible patients at each site, and also if they discontinued belimumab therapy within the initial 6 months [ 26 ]. However, the study did not collect safety data besides those leading to withdrawal.…”

When to use belimumab in SLE

“…Several case series and case reports and subsequently a large multicenter observational study have been carried out after BLISS trials [2][3][4][5][6][7][8][9][10] (Table 1), all converging on belimumab being able to improve control of disease activity and reduce daily corticosteroid intake, which are indeed expected to reduce organ damage in the long term. Unfortunately, those studies did not systematically measure disease activity according to approved scores, as retrospective observations were performed that were influenced by clinical practice.…”

“…Importantly, as a reduction in SLE flares was extensively reported [2][3][4][5][6][7][8], it looks advisable to prompt belimumab especially in patients displaying a relapsing-remitting disease pattern, in whom a significant decrease in flare rate is among the fundamental treatment goals.…”