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Abstract Number: 1870

Phase 2 Trial of Induction Therapy with Anti-CD20 (Rituximab) Followed By Maintenance Therapy with Anti-BAFF (Belimumab) in Patients with Active Lupus Nephritis

Maria Dall'Era1, Cynthia Aranow2, Margaret Byron3, Linna Ding4, Dawn Smilek5, Betty Diamond6 and David Wofsy7, 1University of California, San Francisco, San Francisco, CA, 2The Feinstein Institute for Medical Research, Manhasset, NY, 3Rho Federal Systems, Inc., Chapel Hill, NC, 4National Institute of Allergy and Infectious Diseases, Bethesda, MD, 5Immune Tolerance Network, San Francisco, CA, 6Autoimmune Musculoskeletal and Hematopoietic Diseases, The Feinstein Institute for Medical Research, Manhasset, NY, 7Rheumatology, University of California, San Francisco, San Francisco, CA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: B cell targeting, clinical trials and lupus nephritis

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Session Information

Date: Monday, October 22, 2018

Session Title: 4M081 ACR Abstract: Edmond L. Dubois, MD Memorial Lecture: SLE–Clinical (1870–1874)

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Two randomized, controlled trials of rituximab in patients with lupus and lupus nephritis (LN) did not meet their primary endpoints. A potential explanation is the observation that after treatment with rituximab, serum BAFF levels are elevated and may lead to disease flare by facilitating expansion of and re-population with autoreactive B cells. The CALIBRATE study (NCT 02260934) was designed to test this hypothesis, to determine whether addition of anti-BAFF (belimumab) could enhance the clinical effects of anti-CD20 (rituximab), and assess safety of the combination.

Methods: 43 subjects with active, proliferative LN despite conventional therapy were enrolled in a prospective, randomized, open-label trial that compared two therapeutic regimens. All subjects received iv rituximab (1000mg), cyclophosphamide (750mg), and methylprednisolone (100mg) at wks 0 and 2, and an initial prednisone dose of 40mg/d with taper to 10mg/d by wk 12. At wk 4, subjects were randomized to belimumab (10mg/kg iv at wks 4, 6, 8, and every 4 wks) plus prednisone (RCB group, n=21) versus prednisone alone (RC group, n=22). Complete response (CR) was defined as: (i) urine protein:creatinine ratio (UPCR) <0.5; (ii) eGFR ≥120 or, if <120, eGFR >80% of screening; and (iii) prednisone dose of 10 mg/d. Partial response (PR) differed only in the UPCR criterion (>50% reduction).

Results: The rate of renal response at wk 48 was similar between the two groups (Table I). CR rate was 32% in the RC group and 38% in the RCB group. B cell depletion occurred in both groups by wk 12, but repopulation occurred at different rates (Table II). Median IgG levels remained well within the normal range in both groups (Table II). 5 subjects in the RC group and 2 in the RCB group experienced grade 3 or higher infectious adverse events, and all resolved.

Conclusion: There was no difference in the rate of renal response at wk 48 in subjects who received anti-CD20 therapy followed by anti-BAFF therapy compared with anti-CD20 therapy alone. Anti-BAFF resulted in delayed peripheral B cell repopulation, but was not associated with hypogammaglobulinemia or an increase in serious infectious adverse events. Further analyses at wk 96 will provide information on the effects of anti-BAFF on B cell repertoire and longer term clinical outcomes.

Table I

CR

PR

Failed *

Withdrawn**

RC Group (n=22)

7 (32%)

2 (9%)

12 (55%)

1 (5%)

RCB Group (n=21)

8 (38%)

3 (14%)

8 (38%)

2 (10%)

Table II

Median B Cell Count (cells/uL)

Median IgG Level (mg/dl)

Wk 0

Wk12

Wk 24

Wk 48

Wk 0

Wk 24

Wk 48

RC Group

105

1

21

31

1050

1110

1410

RCB Group

143

1

3

9

984

837

904

*Includes subjects who failed at any point due to lack of renal response, inability to taper steroids, renal flare, or non-renal flare.

**Includes subjects withdrawn for reasons unrelated to lupus.


Disclosure: M. Dall'Era, Genentech, Inc., 5,AstraZeneca, 5; C. Aranow, GlaxoSmithKline, 5,GlaxoSmithKline, 2,EMD Serrono, 2,Xencor, 2,UCB, Inc., 2,Takeda, 2,Janssen, 2; M. Byron, None; L. Ding, None; D. Smilek, None; B. Diamond, None; D. Wofsy, Celgene Corporation, 5,GlaxoSmithKline, 5,Novartis, 5,Takeda, 5.

To cite this abstract in AMA style:

Dall'Era M, Aranow C, Byron M, Ding L, Smilek D, Diamond B, Wofsy D. Phase 2 Trial of Induction Therapy with Anti-CD20 (Rituximab) Followed By Maintenance Therapy with Anti-BAFF (Belimumab) in Patients with Active Lupus Nephritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/phase-2-trial-of-induction-therapy-with-anti-cd20-rituximab-followed-by-maintenance-therapy-with-anti-baff-belimumab-in-patients-with-active-lupus-nephritis/. Accessed February 3, 2023.
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