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Abstract Number: 764

Atacicept: Integrated Safety Profile from Phase II Randomized Placebo-Controlled Studies in Autoimmune Diseases

Patricia Fraser, Wai Chin and Amy Kao, EMD Serono, Billerica, MA

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: autoimmune diseases, B cell targeting, randomized trials, safety and systemic lupus erythematosus (SLE)

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Session Information

Date: Sunday, November 13, 2016

Session Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment - Poster I: Clinical Trial Design and Current Therapies

Session Type: ACR Poster Session A

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

Background/Purpose:  Atacicept, a recombinant fusion protein, targets both BLyS (B lymphocyte stimulator) and APRIL (a proliferation-inducing ligand), B cell activating factors involved in the pathogenesis of B cell-driven autoimmunity. This study aims to summarize safety data from double-blind, placebo-controlled, phase II studies of atacicept in autoimmune diseases.

Methods: Safety data were pooled from 7 studies of atacicept 25, 75 or 150 mg in rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), multiple sclerosis (MS), optic neuritis (ON), and lupus nephritis (LN).

Results: A total of 1262 subjects were included (RA, n=513 [41%]; SLE, n=455 [36%]; MS, n=254 (20%); ON, n=34 (3%); LN, n=6 [1%]); 30% received placebo (PBO), and 10.2%, 22%, and 37.1% received atacicept 25, 75, or 150 mg, respectively. Treatment-emergent adverse events (TEAEs) were similar across groups (atacicept: 75.2%, 77.7% and 75.6% with 25 mg, 75 mg and 150 mg; PBO: 72.3%) (Table 1). Infections/infestations were the most frequent TEAE (atacicept: 33.3%, 47.9% and 49.1% with 25 mg, 75 mg and 150 mg; PBO: 43.1%) and were reported in subjects with SLE (62.4%, 60.4% with 75 mg and 150 mg; PBO: 55.2%), RA (34.8%, 19.4%, 37.4% with 25 mg, 75 mg and 150 mg; PBO: 32.7%), MS/ON (31.7%, 39.7%, 62.2% with 25 mg, 75 mg and 150 mg; PBO: 40.0%), and LN (75% with 150 mg; PBO: 0%). Pneumonia was the most common serious TEAE (atacicept: 0%, 2.1% and 1.1% with 25 mg, 75 mg and 150 mg; PBO: 1.0%) and the most common severe TEAE (atacicept: 0%, 1.1%, 0.9% with 25 mg, 75 mg and 150 mg; PBO: 0.5%). SLE subjects accounted for the majority of serious and severe pneumonia cases (80% and 67%, respectively). Six treatment-emergent deaths were reported (n=3, 2, 1 in RA, SLE, MS), atacicept n = 1, 1, and 3 with 25 mg, 75 mg and 150 mg, PBO n=1; mortality rate/100 subject-years was atacicept 1.05 vs. PBO 0.43. Herpes zoster (HZ) infections were mild/moderate and infrequent (1.3%) but occurred more commonly with atacicept (1.6% vs 0.8%, with atacicept [n=14] vs PBO [n=3]). All 3 PBO-treated subjects and 57% atacicept-treated subjects with HZ had SLE. The proportion of subjects experiencing HZ by dose was: 25 mg (0.8% overall); 75 mg (1.8% overall; 2.5% SLE); and 150 mg (1.7% overall; 2.8% SLE). No serious HZ infections were reported with atacicept.

Conclusion: TEAE rates were similar between atacicept and PBO groups, with infections the most commonly reported. Subjects with SLE appeared more likely to develop infection-related TEAE (ie, HZ) and serious/severe TEAE (ie, pneumonia). Numbers of deaths were low and were observed across the diseases. The safety profile of atacicept appears to be similar to other B cell-targeted therapies, and is being further evaluated in clinical studies of SLE patients. Table 1. Overall analysis set

Placebo

(n=383)

Atacicept 25 mg

(n=129)

Atacicept 75 mg

(n=282)

Atacicept 150 mg

(n=468)

All atacicept-treated subjects

(n=879)

All subjects

(n=1262)

TEAEs, n (%)

277 (72.3)

97 (75.2)

219 (77.7)

354 (75.6)

670 (76.2)

947 (75.0)

Serious TEAEs, n (%)

39 (10.2)

15 (11.6)

42 (14.9)

55 (11.8)

112 (12.7)

151 (12.0)

Severe TEAEs, n (%)

23 (6.0)

10 (7.8)

38 (13.5)

52 (11.1)

100 (11.4)

123 (9.7)

TEAEs leading to treatment discontinuation, n (%)

24 (6.3)

14 (10.9)

25 (8.9)

40 (8.5)

79 (9.0)

103 (8.2)

Thromboembolic events*, n (%)

10 (2.6)

1 (0.8)

6 (2.1)

6 (1.3)

13 (1.5)

23 (1.8)

Non-opportunistic infections, n (%)

277 (72.3)

97 (75.2)

218 (77.3)

351 (75.0)

666 (75.8)

943 (74.7)

Herpes zoster, n (%)

3 (0.8)

1 (0.8)

5 (1.8)

8 (1.7)

14 (1.6)

17 (1.3)

PML, n (%)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Injection site reactions, n (%)

31 (8.1)

27 (20.9)

62 (22.0)

108 (23.1)

197 (22.4)

228 (18.1)

Treatment-emergent deaths, n (%)

1 (0.3)

1 (0.8)

1 (0.4)

3 (0.6)

5 (0.6)

6 (0.5)

*Includes myocardial infarction. TEAE, treatment-emergent adverse event; PML, progressive multifocal leukoencephalopathy


Disclosure: P. Fraser, EMD Serono, 1,EMD Serono, 3; W. Chin, EMD Serono, 3; A. Kao, EMD Serono, 3.

To cite this abstract in AMA style:

Fraser P, Chin W, Kao A. Atacicept: Integrated Safety Profile from Phase II Randomized Placebo-Controlled Studies in Autoimmune Diseases [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/atacicept-integrated-safety-profile-from-phase-ii-randomized-placebo-controlled-studies-in-autoimmune-diseases/. Accessed May 17, 2022.
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