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Abstract Number: 1732

Efficacy and Safety Of Subcutaneous Administration Of Tabalumab, An Anti-B Cell Activating Factor Monoclonal Antibody, In Rheumatoid Arthritis:  Results From a Phase 3 Multicenter, Randomized, Double-Blind Study

MC Genovese1, Gregg J. Silverman2, Paul Emery3, Ramesh Gupta4, Anne Gill5, Wendy J. Komocsar5, Melissa Veenhuizen5, Li Xie5, Pierre-Yves Berclaz5 and Chin Lee5, 1Division of Rheumatology, Stanford University, Palo Alto, CA, 2Rheumatology, NYU School of Medicine, New York, NY, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 4Private Practice, Memphis, TN, 5Eli Lilly and Company, Indianapolis, IN

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: B cells, BAFF, rheumatoid arthritis (RA) and safety

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Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy: Efficacy and Safety of Novel Entities

Session Type: Abstract Submissions (ACR)

 

Background/Purpose: Tabalumab is a monoclonal antibody that neutralizes membrane-bound and soluble B cell activating factor (BAFF). These interim analyses evaluated the efficacy and safety of 2 different subcutaneous (SQ) dosing regimens of tabalumab in RA patients (pts).

Methods: 1004 pts (ITT population) were enrolled in this phase 3, multicenter, randomized, double-blind study that evaluated 2 different SQ tabalumab doses (120 mg every 4 wks [120/Q4W] or 90 mg every 2 wks [90/Q2W]) vs. placebo over 24 wks. At wk 0, pts received an SQ loading dose that was 2 times the planned treatment dose (ie, 240 mg, 180 mg, or placebo). Eligible pts included those with or without background DMARDs having a Patient’s Global Assessment of Disease Activity ≥20/100 mm. Prespecified efficacy analyses were based on a subset of pts (n=849) with ≥5/68 tender and ≥5/66 swollen joints at baseline; the primary endpoint was ACR20 at 24 wks in this subset.

Results:  At baseline, the ITT population comprised mostly women (79%) who were seropositive (77%) with a mean age of 51 yrs, RA diagnosis of 6 yrs, and mean DAS28-CRP of 5.3±1.2; these baseline characteristics were similar to that of the efficacy population. For the efficacy population at wk 24, no significant differences in the percentage of pts who achieved ACR20 (NRI; range: 32%-34%) and ACR50 (NRI; range: 12%-13%), and no differences in mean DAS28-CRP (mLOCF; 4.6±1.5 to 4.7±1.5), mean HAQ-DI (mLOCF; range: 1.2±0.7 to 1.3±0.7), or percent with moderate/good EULAR28 response (mLOCF; range: 47%-50%) were observed. Efficacy results were similar between the efficacy and ITT populations. Discontinuation rates due to an AE were similar across all groups (range: 2%-4%) as were incidences of TEAEs (range: 58%-64%) and SAEs (range: 2%-4%). For the 120/Q4W, 90/Q2W, and placebo groups, incidences of events of interest were infection (23%, 26%, and 22%, respectively), injection-site reaction (6%, 10%, and 3%, respectively), and allergy/hypersensitivity reaction (2%, 5%, and 5%, respectively). Major adverse cardiovascular events were reported in two 120/Q4W pts and one 90/Q2W pt. Three deaths occurred (two 120/Q4W pts and one 90/Q2W pt). Changes in CD3-CD20+ B cells seen in the 120/Q4W and 90/Q2W groups were generally consistent with prior phase 2 results. Over the 24-wk treatment period, decreases in IgM, IgA, and IgG were also observed in both tabalumab groups vs. placebo (Table).

Conclusion: Tabalumab administration had biologic activity demonstrated by changes in B cells and immunoglobulins, but no significant changes in CRP were observed. Despite showing improvements in efficacy measures with intravenous and SQ treatment in three phase 2 trials, no clear clinical benefit and no new, unexpected safety findings were observed for the tabalumab doses evaluated in this larger phase 3 study. Post-hoc analyses to help understand the disparity in responses between phase 2 and phase 3 are planned.

 

 

 

Table. Measures of Biologic Activity

 

120 mg Q4W

N=320a/379b

90 mg Q2W

N=316a/371b

Placebo

N=213a/250b

CRP (mg/L)a

Baseline

Change at wk 24

 

13.3±21.1

-0.2±18.3

 

12.1±16.2

-0.5±14.0

 

11.7±15.2

-0.6±13.8

 

CD3-CD20+ B cells (cells/µL)b

Baseline

Change at wk 24

 

214.2±146.1

-43.2±306.2*

 

213.2±129.9

-67.4±117.8*

 

223.4±129.0

3.5±98.5

 

IgM (g/L)b

Baseline

Change at wk 24

 

1.4±0.8

-0.2±0.3*

 

1.4±0.8

-0.2±0.3*

 

1.5±1.0

0.0±0.3

 

IgA (g/L)b

Baseline

Change at wk 24

 

2.8±1.3

-0.3±0.4*

 

2.9±1.3

-0.3±0.4*

 

2.8±1.2

0.1±0.6

 

IgG (g/L)b

Baseline

Change at wk 24

 

12.5±3.7

-0.8±1.8*

 

12.5±3.6

-0.8±1.8*

 

12.5±3.7

0.1±1.9

 

Data are mean±SD.

aBased on efficacy population.

bBased on safety population (N=1000) who received ≥1 dose.

*P≤0.05 vs. placebo.

 

 

 


Disclosure:

M. Genovese,

Eli Lilly and Company,

2,

Eli Lilly and Company,

5;

G. J. Silverman,

Eli Lilly and Company,

5;

P. Emery,

Pfizer Inc,

5,

Abbvie,

5,

Bausch & Lomb,

5,

Roche Pharmaceuticals,

5,

UCB Inc. ,

5,

Pfizer Inc,

8,

Abbvie,

8,

Roche Pharmaceuticals,

8,

UCB Inc,

8,

Bausch & Lomb,

8,

MSD Pharmaceuticals,

5,

MSD Pharmaceuticals,

8;

R. Gupta,
None;

A. Gill,

Eli Lilly and Company ,

3,

Eli Lilly and Company ,

1;

W. J. Komocsar,

Eli Lilly and Company ,

1,

Eli Lilly and Company ,

3;

M. Veenhuizen,

Eli Lilly and Company,

1,

Eli Lilly and Company,

3;

L. Xie,

Eli Lilly and Company,

1,

Eli Lilly and Company,

3;

P. Y. Berclaz,

Eli Lilly and Company ,

3,

Eli Lilly and Company ,

1;

C. Lee,

Eli Lilly and Company,

1,

Eli Lilly and Company,

3.

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