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Abstract Number: L8

A Randomized, Double-Blind, Parallel-Group Study of the Safety and Efficacy of Tocilizumab Subcutaneous Versus Placebo in Combination with Traditional Dmards in Patients with Moderate to Severe Rheumatoid Arthritis (BREVACTA)

Alan J. Kivitz1, Ewa Olech2, Michael A. Borofsky3, Beatriz M. Zazueta4, Federico Navarro-Sarabia5, Lucy Rowell6, Clare Nasmyth-Miller6 and Janet E. Pope7, 1Altoona Center for Clinical Research, Duncansville, PA, 2Internal Medicine, University of Nevada School of Medicine, Las Vegas, NV, 3Clinical Research Center of Reading, Reading, PA, 4Reumatologia, Centro de Investigacion en Enfermedades Reumaticas, Mexicali, Mexico, 5Rheumatology, University Hospital Virgen Macarena, Sevilla, Spain, 6Roche, Welwyn Garden City, United Kingdom, 7Medicine/Rheumatology, St. Joseph Health Care London, University of Western Ontario, London, ON, Canada

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Clinical, radiography, rheumatoid arthritis (RA) and tocilizumab

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Session Information

Title: ACR Late-breaking Abstracts Poster Session

Session Type: Late-Breaking Abstracts

Background/Purpose: The intravenous formulation of tocilizumab (TCZ) has demonstrated efficacy with a manageable safety profile in patients (pts) with rheumatoid arthritis (RA) in multiple clinical trials.  Subcutaneous (SC) TCZ would allow pts to have the choice of route of administration, and to self-administer. The objective of this study was to compare the efficacy and safety of TCZ SC versus placebo (PBO) in pts with moderately to severely active RA who had an inadequate response to one or more DMARDs (up to 20% could have failed an anti-TNF agent). 

Methods: This 2-year, Phase 3, randomized, multicenter, parallel-group study included a 24-week double-blind, PBO-controlled period followed by open-label treatment for 72-weeks. Data from 24 weeks are presented. Pts were randomized 2:1 to receive TCZ SC 162 mg every other week (q2w) or PBO SC q2w for 24 weeks, in combination with stable doses of pre-study DMARDs. TCZ SC dose was based on previous studies evaluating the PK, PD, efficacy and safety of TCZ SC in pts with RA. Escape therapy with weekly open-label TCZ SC 162 mg was offered at week 12 onwards to pts with less than 20% improvement in both tender and swollen joints. The primary endpoint was to demonstrate superiority of TCZ SC over PBO for ACR20 response at week 24, with a key secondary endpoint being radiographic data. Safety was assessed using AE reports and laboratory results. 

Results: The ITT population contained 656 pts (TCZ SC, n = 437; PBO, n = 219). Mean baseline disease characteristics were similar between TCZ SC and PBO groups: age was 52 years; RA duration was 11 years; and DAS28 was 6.7 and 6.6, respectively. Significantly more pts receiving TCZ SC achieved ACR20 responses at Week 24 compared to PBO (60.9% vs 31.5%). Additionally, significantly more pts receiving TCZ SC achieved ACR50 and ACR70 responses and had significantly greater improvements in DAS28 and HAQ-DI scores from baseline compared to PBO at week 24 (Table). Mean change from baseline in mTSS at week 24 was significantly less for pts receiving TCZ SC compared to PBO. Up to week 24, the percentage of pts with AEs and SAEs were comparable in the TCZ SC and PBO groups (Table). The most common AE in both groups was infection. Injection site reactions occurred more frequently in the TCZ SC group compared to the PBO group (7.1% vs 4.1%) but hypersensitivity reactions were similar between the groups (4.3% vs 3.7%).  There were no serious hypersensitivity reactions. There were 3 deaths in the TCZ SC group, and none on placebo, however numbers were small.

Conclusion: TCZ SC demonstrated significantly greater efficacy, including ACR end points and inhibition of joint damage, compared to PBO. The AE profile with TCZ SC was comparable to previous studies with TCZ IV. Further results from this 96 week study will extend the findings. TCZ SC is an effective treatment in RA, and will offer an alternative route of administration and the possibility of self-administration for pts.

 

Efficacy and Safety at Week 24 of TCZ SC vs. PBO

 

TCZ SC 162 mg q2w

PBO SC q2w

P-value

Efficacy and radiographic outcomes (ITT population)

 

N

437

219

–

ACR20, %

60.9

31.5

< 0.0001

ACR50, %

39.8

12.3

< 0.0001

ACR70, %

19.7

5.0

< 0.0001

Change in DAS28 from baseline, mean ±SD

-3.25±1.37

-1.79±1.34

–

Change in HAQ-DI  from baseline, mean ±SD

-0.50±0.58

-0.32±0.59

–

Change in mTSS from baseline, mean±SD

0.62±2.7

1.23±2.8

0.0149

Safety assessments (Safety population)

 

N

437

218

–

Withdrawals, n (%)

26(5.9)

7 (3.2)

–

Escape to open label weekly TCZ SC, n (%)

72 (16.5)

90 (41.1)

–

Patients with ≥ 1 AE, n (%)

274 (62.7)

126 (57.8)

–

Patients with ≥ 1 SAE, n (%)

20 (4.6)

8 (3.7)

–

Patients with ≥ 1 infection, n (%)

131 (30.0)

61 (28.0)

–

Patients with ≥ 1 serious infection, n (%)

9 (2.1)

4 (1.8)

–

Patients with ≥ 1 injection site reaction, n %

31 (7.1)

9 (4.1)

–

Hypersensitivity, n (%)

19 (4.3)

8 (3.7)

–

Deaths, n (%)

3 (0.7)

0 (0)

–


Disclosure:

A. J. Kivitz,

Genentech and Biogen IDEC Inc.,

2,

Genentech,

5;

E. Olech,

Genentech,

2,

Genentech,

5;

M. A. Borofsky,
None;

B. M. Zazueta,
None;

F. Navarro-Sarabia,

Roche, BMS, Pfizer, UCB, Abbott, Meijii Seika,

5,

Roche, BMS, Pfizer, UCB, Abbott, Meijii Seika,

8;

L. Rowell,

Roche Products Ltd,

3;

C. Nasmyth-Miller,

Roche Products Ltd,

3;

J. E. Pope,
None.

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