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Abstract Number: 2678

Integrated Safety Profile of Atacicept from All Clinical Studies to Date

Caroline Gordon1,2, Roberto Bassi3, Peter Chang4, Amy H. Kao3, David Jayne5, David Wofsy6, Victor Ona3 and Patricia Fleuranceau-Morel3, 1Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom, 2University of Birmingham, Birmingham, United Kingdom, 3EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, 4EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), BIllerica, MA, 5Department of Medicine, University of Cambridge, Cambridge, United Kingdom, 6Rheumatology, University of California, San Francisco, San Francisco, CA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: APRIL, BLyS, SLE and safety

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Session Information

Date: Tuesday, October 23, 2018

Session Title: Systemic Lupus Erythematosus – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

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

Background/Purpose:

We conducted an integrated analysis of pooled safety data from all 17 atacicept clinical studies to date, across multiple indications, to further define atacicept’s safety profile.

Methods:

Analyses were based on 3 pooled datasets: Double-blind placebo (PBO)-controlled set (DBPC-S n=1,568; key endpoint: treatment-emergent AEs [TEAEs]); SLE set (SLE-S n=761; key endpoint: IgG change and serious infection rates); full analysis set (FA-S n=1,845; key endpoint: exposure-adjusted mortality).

Results:

Of 1,568 patients in the DBPC-S, 30.8% received PBO, and 8.2%, 24.5% and 36.5% received atacicept 25, 75 and 150 mg, respectively. Overall, baseline characteristics were balanced across treatment arms. Treatment exposure was similar with PBO and atacicept 75 mg and 150 mg (278.3, 225.0 and 286.7 patient-years, respectively), but was lower with atacicept 25 mg (51.5 patient-years). Exposure-adjusted TEAE rates were generally higher with atacicept vs placebo, with no consistent association between atacicept dose and cardiac arrhythmias, serious and severe infections or injection site reactions (Table). Serious infection and serious TEAE rates were similar between atacicept and PBO. TEAE-related discontinuation rates were higher with atacicept versus placebo (16.1 vs 10.9/100 patient-years). In the SLE-S, there was no association between reduced IgG levels and increased infection rates. Across all studies (FA-S), 11 patients died during treatment (10 atacicept [0.5%], 1 PBO [0.1%]; see Table for infection-related deaths in the DBPC-S). Exposure-adjusted mortality rates/100 patient-years (95% CI) were 3.60 (0.90–14.38), 0.34 (0.05–2.43), 1.18 (0.49–2.82) for atacicept 25, 75 and 150 mg, and 0.44 (0.06–3.12) with PBO.

Conclusion:

Results from this pooled analysis clarify the benefit-risk relationship for atacicept, which is being further evaluated in additional clinical studies in IgA nephropathy and SLE.

Table. Exposure-adjusted TEAE rates by dose (DBPC-S)
Atacicept
PBO n=483 25 mg, n=129 75 mg, n=384 150 mg, n=572 All, n=1,085 Total, n=1,568
Total number of patient-years 278.3 51.5 225.0 286.7 563.2 841.4
TEAE, n (per patient-years)
Hypersensitivity* 37 (13.9) 8 (15.7) 40 (19.1) 55 (20.4) 103 (19.4) 140 (17.6)
Infections 211 (107.8) 43 (104.4) 180 (118.7) 281 (141.3) 504 (128.7) 715 (121.7)
Herpes zoster 13 (4.7) 2 (3.9) 10 (4.5) 17 (6.1) 29 (5.2) 42 (5.1)
Serious infection 20 (7.3) 1 (1.9) 23 (10.5) 22 (7.7) 46 (8.3) 66 (7.9)
Severe infection 9 (3.2) 0 11 (4.9) 16 (5.6) 27 (4.8) 36 (4.3)
Injection-site reactions 54 (20.9) 27 (64.8) 109 (63.0) 156 (72.4) 292 (67.9) 346 (50.2)
Severe hypogammaglobulinemia (IgG <3 g/L) 0 0 2 (0.9) 4 (1.4) 6 (1.1) 6 (0.7)
Cardiac arrhythmias [all]* 18 (6.6) 11 (22.4) 23 (10.6) 25 (8.9) 59 (10.8) 77 (9.4)
Ventricular arrhythmias 5 (1.8) 0 4 (1.8) 6 (2.1) 10 (1.8) 15 (1.8)
Ischaemic heart disorders* 11 (4.0) 3 (5.9) 13 (5.9) 11 (3.9) 27 (4.9) 38 (4.6)
Embolic and thromboembolic events* 11 (4.0) 1 (2.0) 6 (2.7) 9 (3.2) 16 (2.9) 27 (3.2)
Vestibular disorders* 19 (7.0) 5 (9.9) 18 (8.3) 26 (9.3) 49 (8.9) 68 (8.3)
Demyelination* 1 (0.4) 1 (1.9) 0 5 (1.7) 6 (1.1) 7 (0.8)
Depression* 14 (5.1) 3 (5.8) 8 (3.6) 11 (3.9) 22 (3.9) 36 (4.3)
Malignant tumour* 0 1 (1.9) 1 (0.4) 3 (1.1) 5 (0.9) 5 (0.6)
Serious TEAE 51 (18.9) 15 (30.0) 51 (23.9) 61 (21.8) 127 (23.4) 178 (21.9)
Severe TEAE 28 (10.2) 10 (19.6) 45 (20.9) 56 (20.0) 111 (20.3) 139 (17.0)
Discontinuation of treatment due to TEAE 30 (10.9) 14 (27.6) 30 (13.4) 46 (16.1) 90 (16.1) 120 (14.3)
Deaths related to infections, n (%)
Deaths 0 0 0 2 (0.3)† 0 0

*Programmatically determined (crude results of the search) from a predefined list of MedDRA preferred terms according to the Standardized MedDRA Query (SMQ) or Customized MedDRA Query (CMQ) classification of the corresponding MedDRA version

†Acute respiratory failure and probably leptospirosis (n=1); pneumonia and pulmonary alveolar haemorrhage (n=1)


Disclosure: C. Gordon, EMD Serono, 5, 9; R. Bassi, EMD Serono, 3; P. Chang, EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), 3; A. H. Kao, EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), 3; D. Jayne, Chemocentryx, GlaxoSmithKline, Sanofi, Roche, 2,Boehringer-Ingelheim, Astra-Zeneca, AbbVie, CSL, InflaRx, Bristol-Myers Squibb, Takeda, 5,Aurinia, 6; D. Wofsy, Celgene Corporation, 5,GlaxoSmithKline, 5,Novartis, 5,Takeda, 5; V. Ona, EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), 3; P. Fleuranceau-Morel, EMD Serone Research and Development Institute, Inc., Billerica, MA, USA; a business of Merck KGaA, Darmstadt, Germany, 3.

To cite this abstract in AMA style:

Gordon C, Bassi R, Chang P, Kao AH, Jayne D, Wofsy D, Ona V, Fleuranceau-Morel P. Integrated Safety Profile of Atacicept from All Clinical Studies to Date [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/integrated-safety-profile-of-atacicept-from-all-clinical-studies-to-date/. Accessed February 6, 2023.
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