Background/Purpose:  Much of the published experience with belimumab in lupus patients has derived from clinical trials.   We examined the non-sponsored experience with belimumab in routine clinical practice among 15 U.S. lupus centers participating in a national patient registry, the Lupus Clinical Trials Consortium, Inc. (LCTC).

Methods:  The LCTC registry consists of consecutively enrolled adults with SLE from U.S. centers, each contributing approximately 100 patients.  Patients who received at least one belimumab infusion after enrollment in the registry between March 2011, the date of FDA approval, and April 2013 were analyzed.  We investigated clinical characteristics, indications for belimumab, and reasons for discontinuation.  We calculated changes in SELENA-SLEDAI, physician global assessment, glucocorticoid dose, and serological parameters between baseline and follow-up at 6 months and 1 year for those maintained on the drug.

Results:  Among 1189 patients followed for 27,469 months (mean 23.2 months), 68 patients started belimumab (5.7%).  Mean treatment duration was 13.2 months (SD 6.7).  Three centers started no patients on the drug, and the remaining started between 1-5 patients.   In the 68 treated patients, mean age was 39.1 years (SD 12), 94% were female, 41% Caucasian, 47% Black and 12% Hispanic.  Mean disease duration was 10.7 years (SD 8).  Mean SELENA-SLEDAI at drug initiation was 4.4 (SD 4.3, range 0-22).  30 patients (44%) had a positive dsDNA upon starting belimumab and 15 (22%) had low complements.  The mean physician global assessment was 1.4 on a scale of 0-3 (SD 0.7).  56 patients (82%) were on glucocorticoids, with a mean prednisone dose of 14.6 mg (SD 23).  27% received azathioprine, 31% mycophenolate mofetil, 15% methotrexate, and 75% an anti-malarial.  The most common reasons for belimumab initiation were arthritis (52%), mucocutaneous disease (19%), and serositis (8%).   12 patients received the drug solely for maintenance, and 4 solely for steroid-sparing.  After 898 person-months of follow-up, 18 patients discontinued belimumab (4 for adverse events/intolerability, 3 lack of efficacy, 3 no longer needed it, 3 patient preference, and 1 for insurance reasons).  Response at 6 months and 1 year for those maintained on belimumab is shown in the Table.

Conclusion :   Since the approval of belimumab, 5.7% of patients enrolled in the LCTC registry have received the drug in routine clinical practice.  Utilization was similar across centers; the primary indications were arthritis and mucocutaneous disease.   After 6 and 12 months, there were statistically significant improvements in SELENA- SLEDAI and physician global assessment.  There was no statistically significant steroid-sparing effect.  65% of patients remained on belimumab by one year. 

The authors thank and acknowledge the Lupus Clinical Trials Consortium, Inc. (LCTC). The views expressed in this report are those of the authors and LCTC is not responsible for its specific content.