Background/Purpose: Belimumab (Benlysta) is a monoclonal antibody that inhibits soluble B-Lymphocyte Stimulator and improves SLE disease activity. This study was initiated to evaluate the use of Belimumab in academic SLE clinical practices.

Methods: An invitation to participate was sent to 16 physicians experienced in SLE Phase III clinical trials. All agreeing to participate completed a one page questionnaire for each patient prescribed Belimumab.  The questionnaire contained demographic information on each patient (age, gender, race/ethnicity), SLE data (duration of disease, SELENA-SLEDAI, clinical manifestation(s) targeted, background medications), and Belimumab information (start date, clinical response, side effects).  Clinical response was defined as the investigator’s impression of a ≥50% improvement in the initial manifestation being treated and no worsening in other organ systems.

Results: Of 16 invitations sent, ten investigators accepted to participate in the study. Questionnaires on 83 treated patients were returned.  The mean age was 43.9±11.2 years old, 94% were female, 65.1% White, 24.1% Black, 8.4% Asian, and 6.0% Hispanic. The average SLE disease duration was 11.1±8.4 years. All patients were ANA positive. Concomitant medications included: antimalarials in 74.7% immunosuppressants in 75.9% (Azathioprine 19.3%, Mycophenolate Mofetil 43.4%, Methotrexate 13.3%), and prednisone in 72.3% (average dose of 11.3±11.5 mg, 63.3% on ≥10 mg).  Only 2.4% of patients were not on background SLE medications. The dominant clinical manifestation driving treatment was arthritis (74.7%) followed by rash (41.0%) and serositis (15.7%). Other SLE manifestations included renal (7.2%, 4 membranous, 2 proliferative), hematological (8.4%), and inability to taper steroids (8.4%).  Approximately half of patients (55.4%) had two or more active manifestations. Forty-two patients were on Benlysta for at least 3 months. Of those, 23 (55%) patients clinically responded by 3 months with marked improvement in arthritis and/or rash. Twenty-three patients were on Benlysta for at least 6 months. Of those, 14 (60.9%) patients clinically responded with improvements in arthritis and/or rash. Of the 6 patients in whom Benlysta was discontinued, 2 had CNS lupus, 1 MI, 1 infection, 1 infusion reaction, and 1 elective surgery.

Conclusion: These early data support the use of Benlysta across all ethnic groups and efficacy similar to that reported in the Phase III trials.  Relevant to physician and patient decision making, improvement was observed within 3 months.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/favorable-response-to-belimumab-at-three-months/