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Safety and efficacy of belimumab plus standard therapy for up to 13 years in patients with systemic lupus erythematosus

Author

Wallace DJ1, Ginzler EM2, Merrill JT3, Furie RA4, Stohl W5, Chatham WW6, Weinstein A7, McKay JD8, McCune WJ9, Petri M10, Fettiplace J11,12, Roth DA13, Ji B11, Heath A14,15. Arthritis Rheumatol. 2019 Feb 16. doi: 10.1002/art.40861.

Author Information

1 Cedars-Sinai Medical Center, University of California-Los Angeles, CA, USA.

2 State University of New York Downstate Medical Center, Brooklyn, NY, USA.

3 Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.

4 Northwell Health, Great Neck, NY, USA. 

5 University of Southern California Keck School of Medicine, Los Angeles, CA, USA.

6 University of Alabama at Birmingham, Birmingham, AL, USA.

7 Georgetown University, Washington, DC, USA.

8 Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.

9 University of Michigan, Ann Arbor, MI, USA.

10 Johns Hopkins University School of Medicine, Baltimore, MD, USA.

11 GSK, Uxbridge, Middlesex, UK.

12 Mundipharma Research, Cambridge, UK.

13 GSK, Philadelphia, PA, USA.

14 GSK, Raleigh-Durham, NC, USA.

15 AptaStats LLC, Cary, NC, USA.

Abstract

OBJECTIVE

Investigate long-term safety and efficacy of intravenous (IV) belimumab plus standard systemic lupus erythematosus(SLE) therapy (SoC) in active, autoantibody-positive SLE.

METHODS

This was a multicenter, open-label, continuation study of IV belimumab given every four weeks with SoC in patients with SLE who completed a Phase II, double-blind study. Adverse events (AEs) and laboratory data were monitored from the first belimumab dose (in either study) until 24 weeks after the final dose. Efficacy assessments (every 16 weeks) included SLE Responder Index (SRI), flares and corticosteroid use (every 4 weeks).

RESULTS

Of 476 patients in the parent study, 298 (62.6%) entered the continuation study; 96 (32.2%) remained in the study. Patients received belimumab for up to 13 years (median [range] 3334.0 [260, 4332] days; total belimumab exposure 2294 patient-years; median [range] number of infusions 115.5 [7, 155]). The percentage of patients with AEs each year remained stable or decreased. The majority of patients maintained normal IgG levels and the rate of infections remained stable. The percentage of patients who achieved an SRI response increased from 32.8% (Year 1) to 75.6% of those remaining on treatment at Year 12. Corticosteroid dose decreased for patients receiving >7.5 mg/day at baseline.

CONCLUSIONS

This study reports the longest duration of belimumab treatment in clinical trials. Belimumab was well tolerated with no new safety concerns, and efficacy was maintained in patients who continued the study. For patients who initially respond to belimumab, the treatment continues to be well tolerated and provides long-term disease control.