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Abstract Number: 2627

Not All Clinical Responders in SLE Are Equal: Comparison of Subcutaneous Belimumab + Standard of Care Responders to Placebo + Standard of Care Responders

William Stohl1, Milena Kurtinecz2, Joe Eastman3, Vanessa Castellano4, Chrysa Mahoney4, Tania Gonzalez-Rivera2 and Bonnie Pobiner4, 1Division of Rheumatology, University of Southern California Keck School of Medicine, Los Angeles, CA, 2GlaxoSmithKline, Philadelphia, PA, 3GlaxoSmithKline (at the time of the study), Research Triangle Park, NC, 4GlaxoSmithKline, Research Triangle Park, NC

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: belimumab, Clinical Response, outcomes, systemic lupus erythematosus (SLE) and treatment

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Session Information

Date: Tuesday, October 23, 2018

Session Title: Systemic Lupus Erythematosus – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: To determine whether degree of response among responders to subcutaneous (SC) belimumab (BEL) + standard of care (SoC) is greater than that for responders to placebo (PBO) + SoC.

Methods: Patients with SELENA-SLEDAI (SS) ≥8 on stable SoC ≥30 days were randomized (2:1) to weekly SC BEL 200 mg + SoC or PBO + SoC in BLISS-SC (NCT01484496). Primary endpoint was SLE Responder Index 4 (SRI4) at week (Wk) 52 (≥4-point SS reduction, <0.3 increase in Physician’s Global Assessment [PGA], and 0 new BILAG A or ≤1 new BILAG B organ domain scores, all vs baseline [BL]). SRI4 responders were compared based on treatment (BEL vs PBO) for changes in clinical and laboratory parameters. SRI4 non-responders were also evaluated.

Results: 61.4% of BEL + SoC and 48.4% of PBO + SoC were SRI4 responders1. BEL + SoC responders had better outcomes than PBO + SoC responders at Wk 52 (Table 1) and during the trial: greater % reductions in SS (Wk 20-52, p≤0.0199) and PGA scores (Wk 20-52, p≤0.0304); organ system improvement (SS Wk 52 immunologic [p=0.0064] and vascular [p=0.0199] and BILAG vasculitis [Wk 16-52, p≤0.0301]); 65% reduced risk of severe flare (HR=0.35 [95% CI: 0.13, 0.94], p=0.0367); normalized complement levels (Wk 16-20,28-36, 44, 52: C3 p≤0.0232 and Wk 16-24, 36-52: C4 p≤0.0303). Percent of patients with ≥ 5, 6, 7, or 8 point reductions in SS excluding serology (anti-dsDNA, complement) were numerically greater for BEL + SoC responders from Wk 8-52, with significant differences at earlier timepoints (Table 2). Among patients receiving BL prednisone >7.5 mg/day, more BEL + SoC responders reduced their CS dose ≥25% to ≤7.5 mg/day during Wks 40-52 vs PBO + SoC responders but did not reach statistical significance (23.8% vs 14.6%, OR 1.79 [95% CI: 0.89, 3.59], p=0.1008). Anti-dsDNA shifts and FACIT-fatigue score improvements were similar between groups. Non-responders had no significant differences, irrespective of treatment, in changes in SS (± serology) or PGA, organ system involvement, flares, steroid use, complement, anti-dsDNA, or FACIT-fatigue scores. BL BAFF levels (range 1.574-1.769 ng/mL) and SoC medications were similar across treatment groups regardless of SRI4 response. No gender differences were noted.

Conclusion: SRI4 responders with BEL + SoC had greater degree of response compared to PBO + SoC based on clinical and serological measures. Earlier SS reductions (± serology) for BEL + SoC responders points to more rapid clinical improvement. These observations add robustness to existing knowledge that treatment with BEL could add therapeutic benefit to SoC alone.

Reference – 1. Arth Rheum 2017;69:1016-27.

Table 1 – Comparison of changes from BL to Wk 52 in clinical and laboratory parameters between BEL + SoC SRI4 Responders and PBO + SoC SRI4 Responders (based upon intent-to-treat population)
BEL + SoC PBO + SoC p-value
Patients, n 340 135
SELENA-SLEDAI reduction, n (%)
≥ 5 point reduction 283 (83.2%) 95 (70.4%) 0.0024
≥ 6 point reduction 274 (80.6%) 94 (69.6%) 0.0145
≥ 7 point reduction 178 (52.4%) 53 (39.3%) 0.0110
≥ 8 point reduction 174 (51.2%) 50 (37.0%) 0.0059
Number of organ domains improved
SELENA-SLEDAI, mean ± SE 2.1 ± 0.04 1.9 ± 0.06 0.0233
BILAG, mean ± SE 1.6 ± 0.04 1.6 ± 0.07 0.1230
% change in PGA from BL in patients, mean ± SE -67.1 ± 1.5 -58.2 ± 2.9 0.0054
Prednisone reduction by ≥ 25% from BL to ≤ 7.5 mg/day during Wks 40-52 in patients with BL prednisone >7.5 mg/d, n/N (%)

49/206 (23.8%)

12/82 (14.6%)

0.1008
Patients with flares by SFI (SLE Fare Index), n (%)
Severe 8 (2.4%) 8 (5.9%) 0.0367
Mild-Moderate 189 (55.6%) 83 (61.5%) 0.2061
C3 complement shifts – Low to Normal/High, n/N (%) 74/150 (49.3%) 13/55 (23.6%) 0.0013
C4 complement shifts – Low to Normal/High, n/N (%) 52/91 (57.1%) 7/29 (24.1%) 0.0026
Anti-dsDNA shifts – Positive to Negative, n/N (%) 50/242 (20.7%) 21/94 (22.3%) 0.7666
FACIT-Fatigue Scale Score exceeding ≥4 (minimal clinically important difference), n/N (%) 191/340 (56.2%) 65/135 (48.1%) 0.2868
Table 2 – SELENA SLEDAI reductions ≥ 5, 6, 7, or 8 points excluding serology (complement, anti-dsDNA) – Study weeks with significant differences (p<0.05) for BEL + SoC SRI4 Responders vs PBO + SoC SRI4 Responders (based upon intent-to-treat population)
BEL + SoC PBO + SoC p-value
Patients, n 340 135
SELENA-SLEDAI reduction, n (%)
Wk 8
≥ 8 point reduction 48 (14.1%) 10 (7.4%) 0.0444
Wk 12
≥ 7 point reduction 81 (23.8%) 20 (14.8%) 0.0344
≥ 8 point reduction 78 (22.9%) 19 (14.1%) 0.0321
Wk 16
≥ 7 point reduction 101 (29.7%) 26 (19.3%) 0.0216
≥ 8 point reduction 96 (28.2%) 24 (17.8%) 0.0192
Wk 20
≥ 5 point reduction 194 (57.1%) 62 (45.9%) 0.0321
≥ 7 point reduction 113 (33.2%) 28 (20.7%) 0.0075
≥ 8 point reduction 108 (31.8%) 27 (20.0%) 0.0128
Wk 24
≥ 7 point reduction 126 (37.1%) 31 (23.0%) 0.003
≥ 8 point reduction 120 (35.3%) 28 (20.7%) 0.0020
Wk 44
≥ 5 point reduction 249 (73.2%) 85 (63.0%) 0.0341
Wk 48
≥ 5 point reduction 249 (73.2%) 86 (63.7%) 0.0448

Disclosure: W. Stohl, GSK, 2,Janssen, 5,Gilead, 2; M. Kurtinecz, GSK, 3; J. Eastman, GSK, 1, 3; V. Castellano, GSK, 1, 3; C. Mahoney, GSK, 1, 3; T. Gonzalez-Rivera, GSK, 3; B. Pobiner, GSK, 1, 3.

To cite this abstract in AMA style:

Stohl W, Kurtinecz M, Eastman J, Castellano V, Mahoney C, Gonzalez-Rivera T, Pobiner B. Not All Clinical Responders in SLE Are Equal: Comparison of Subcutaneous Belimumab + Standard of Care Responders to Placebo + Standard of Care Responders [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/not-all-clinical-responders-in-sle-are-equal-comparison-of-subcutaneous-belimumab-standard-of-care-responders-to-placebo-standard-of-care-responders/. Accessed April 13, 2021.
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