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Abstract Number: 447

Long-Term Safety and Efficacy of Tabalumab, an Anti-B-Cell Activating Factor Monoclonal Antibody, in Patients with Rheumatoid Arthritis:  A 52-Week, Open-Label Extension Study

Maria W. Greenwald1, Leszek Szczepanski2, Alastair C. Kennedy3, Chin H. Lee4, Emery Polasek5, Melissa Veenhuizen4, Rebecca Jones-Taha6 and Pierre-Yves Berclaz5, 1Desert Medical Advances, Palm Desert, CA, 2Wydz. Fizjoterapii, Wyzsza Skola Spoleczno-Przyrodnicza, Poland, 3Alastair C. Kennedy, MD, Vero Beach, FL, 4Eli Lilly and Company, Indianapolis, IN, 5Eli Lilly & Company, Indianapolis, IN, 6PharmaNet/i3, Blue Bell, PA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: BAFF and rheumatoid arthritis (RA)

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Session Information

Session Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Tabalumab, a monoclonal antibody that neutralizes membrane-bound and soluble B cell activating factor (BAFF), has been shown to reduce rheumatoid arthritis (RA) signs and symptoms1. This open-label study evaluated the long-term safety and efficacy of tabalumab in RA patients (pts).

 

Methods:

This 52-week (wk), open-label, flexible-dose extension study enrolled pts who completed 24 wks of a randomized, controlled trial (RCT) of tabalumab vs placebo (pb) and received study drug for ≥6 or 12 wks.  Pts remained on stable MTX doses throughout. In RCT 1, pts received pb or tabalumab 30 or 80 mg IV every 3 wks for 6 wks and followed-up for 18 wks.  In RCT 2, pts received pb or tabalumab 1, 3, 10, 30, 60, or 120 mg SC every 4 wks (Q4W) for 24 wks. At extension study start, all pts received SC tabalumab 60 mg Q4W for 48 wks; a 1-time increase to tabalumab 120 mg Q4W (60/120 mg) and 1-time decrease to 60 mg Q4W per pt was allowed (60/120/60 mg).

 

Results:

Of those who completed RCT 1 or 2, 98% (N=182, safety population) enrolled:  tabalumab 60 mg (n=60), tabalumab 60/120 mg (n=121), and 1 pt after taking tabalumab 120 mg then returned to 60 mg. Baseline (pre-tabalumab) RA activity levels were generally higher for the 60/120 mg group. Overall, both groups appeared to maintain efficacy with long-term treatment (Table 1). One pt died due to myocardial infarction (60/120 mg). In each group, 5% discontinued due to an adverse event (AE). There was a higher frequency of serious AEs (SAEs) and treatment-emergent AEs (TEAEs, including severe events) as well as events of interest, including infections and injection-site reactions in the 60/120 mg group. Most infections involved the upper respiratory tract. One pt (60/120 mg) reported a fungal skin infection. No clinically significant differences in hematologic or chemistry values, vital signs, or ECGs were seen. Total B lymphocyte counts decreased by ~40% from pre-tabalumab baseline for all groups. The incidence of treatment-emergent, anti-tabalumab antibodies was 4.4% (8/182). Table 2 shows more detailed safety data.

Conclusion:

Despite prior treatment differences, the majority of pts in both treatment groups appeared to maintain efficacy response with long-term, open-label tabalumab treatment. No unexpected safety signals were observed, although a higher frequency of SAEs and severe TEAEs were observed in the 60/120 mg group. Reductions in total B cells were consistent with prior tabalumab studies.

1Genovese et al. [abstract]. Arthritis Rheum 2009;60 Suppl 10:1923


 

Table 1. Efficacy Outcomes In Extension Study

 

Tabalumab (60 mg)

N=59

Tabalumab (60/120 mg)

N=120

All Patients

N=180b,c

Week 24

Week 52a

Week 24

Week 52a

Week 24

Week 52a

ACR20 response, %

69.6

66.1

40.7

32.5

50.0

43.3

ACR50 response, %

35.7

33.9

20.4

13.3

25.3

20.0

ACR70 response, %

12.5

18.6

5.3

6.7

7.6

10.6

ACR-N, mean (SD)

28.7 (53.6)

31.9 (47.6)

-8.9 (126.7)

11.3 (46.4)

3.0 (109.8)

18.8 (47.7)

EULAR [good+moderate], %

88.5

83.9

56.0

55.6

66.0

64.9

Baseline DAS28, mean (SD)

5.5 (1.3)

6.0 (1.1)

5.8 (1.2)

Change in DAS28, mean (SD)

-2.0 (1.5)

-2.1 (1.5)

-1.2 (1.4)

-1.3 (1.5)

-1.4 (1.5)

-1.5 (1.5)

Baseline HAQ, mean (SD)

1.54 (0.66)

1.72 (0.56)

1.66 (0.60)

Change in HAQ, mean (SD)

-0.25 (0.53)

-0.27 (0.53)

-0.26 (0.56)

-0.30 (0.62)

-0.26 (0.55)

-0.29 (0.59)

aFor ACR measures, patients who discontinued from study prior to Week 52 are imputed as non-responders (n=34), for all other measures the LOCF approach was used.

bOnly 1 patient received 60/120/60 mg tabalumab; this patient is included in All Patient data.

cTwo patients were excluded from efficacy analyses: 1 patient had no post-baseline efficacy data (60 mg) and was lost to follow-up, and 1 patient was removed due to good clinical practice violations (60/120 mg).

 

 


 

 

Table 2.  Safety and Pharmacodynamic Outcomes

 

Tabalumab (60 mg)

N=60

Tabalumab (60/120 mg)

n=121

All Patients

N=182a

 

Week 52

Week 52

Week 52

Discontinued due to AEs, n (%)

3 (5.0)

6 (5.0)

9 (4.9)

Deaths, n (%)

0 (0.0)

1 (0.8)

1 (0.5)

Serious AEs, n (%)

4 (6.7)

16 (13.2)

21 (11.5)

Treatment-emergent AEs, n (%)

38 (63.3)

95 (78.5)

134 (73.6)

Infection

22 (36.7)

58 (47.9)

80 (44.0)

Infections of the upper respiratory tractb

16 (25.0)

32 (25.4)

47 (25.8)

Urinary tract infection

2 (3.3)

13 (10.7)

15 (8.2)

RA (eg, worsening, flare)

11 (18.3)

30 (24.8)

41 (22.5)

Injection-site reaction

2 (3.3)

13 (10.7)

15 (8.2)

Injection-site pain

2 (3.3)

12 (9.9)

14 (7.7)

 

aOnly 1 patient received 60/120/60 mg tabalumab; this patient is included in All Patient data.

bIncludes MedDRA High Level Terms of Upper Respiratory Tract Infections NEC; Laryngitis, Nasopharyngitis, Pharyngitis, Pharyngotonsillitis, Rhinitis, Sinusitis, Upper Respiratory Tract Infection.

 

 

 

 


Disclosure:

M. W. Greenwald,

Eli Lilly and Company ,

2;

L. Szczepanski,
None;

A. C. Kennedy,
None;

C. H. Lee,

Eli Lilly and Company,

1,

Eli Lilly and Company,

3;

E. Polasek,

Eli Lilly and Company,

3;

M. Veenhuizen,

Eli Lilly and Company ,

3,

Eli Lilly and Company,

3;

R. Jones-Taha,
None;

P. Y. Berclaz,

Eli Lilly and Company ,

3.

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