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Abstract Number: 2585

Secukinumab Immunogenicity in Patients with Psoriatic Arthritis and Ankylosing Spondylitis during a 52-Week Treatment Period

Atul A. Deodhar1, Dafna D Gladman2, Iain B. McInnes3, Vibeke Strand4, Mengyuan Ren5, Sebastian Spindeldreher6, Luminita Pricop7, Brian Porter7, Jorge Safi7, Abhijit Shete8 and Gerard Bruin6, 1Oregon Health & Science University, Portland, OR, 2Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, 3Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, 4Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 5Novartis Pharmaceuticals, Shanghai, China, 6Novartis Institutes for BioMedical Research, Basel, Switzerland, 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ, 8Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adverse events, antibodies and interleukins (IL), Biologics, Safety issues

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Session Information

Date: Tuesday, October 23, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

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

Background/Purpose: Secukinumab, a fully human monoclonal IgG1 antibody (mAb) that selectively targets IL-17A, is efficacious for the treatment of psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS). mAb therapies may be associated with immunogenicity and the production of anti-drug antibodies (ADAb) that may cause adverse events (AEs) and/or affect drug pharmacokinetics and clinical response. Secukinumab immunogenicity occurred in 0.4% of patients with plaque psoriasis and not associated with loss of efficacy or issues of clinical concern.1 Here we report the immunogenicity of secukinumab in PsA and AS patients treated with secukinumab for up to 52 weeks (Wks).

Methods: Immunogenicity in patients with PsA (FUTURE 1–3 studies) and AS (MEASURE 1–4 studies) exposed to secukinumab was evaluated at baseline (BL) and Wks 16 (AS only), 24, and 52. ADAb were defined as a positive ADAb (ADAb+) signal in ≥1 post-secukinumab treatment sample in patients negative at BL. ADAb positive samples were analyzed for drug-neutralizing potential, immunogenicity-related AEs and ADAb impact on secukinumab pharmacokinetics and efficacy through Wk 52.

Results: Of 1414 treated PsA and 1163 treated AS patients with samples for immunogenicity evaluation, 5 (0.35%) and 8 (0.68%) developed ADAb, respectively, over 52-wks (Table). All but 1 ADAb+ PsA patients were biologic-naïve; 2/5 PsA and 1/8 AS ADAb+ patients received concomitant methotrexate, and 2/8 AS ADAb+ patients received concomitant sulfasalazine. Associations between ADAb and secukinumab dose, frequency or mode of administration were not observed. ADAb were neutralizing in only 1 patient (with PsA), and none were associated with any immunogenicity-related AE. All ADAb were associated with normal secukinumab pharmacokinetics and none were associated with loss of secukinumab efficacy over 52 wks (Table). In the pharmacokinetics samples from patients with PsA or AS at the time points that immunogenicity was measured, 96% had secukinumab serum concentration below the drug tolerance level of 53.8 μg/ml, confirming sufficient immunogenicity sensitivity during treatment with secukinumab.

Conclusion: Secukinumab treatment was associated with a low incidence of immunogenicity in PsA and AS patients, as shown by ADAb detection in only 0.35% PsA patients and 0.68% AS patients over 52 wks in a database of >2500 patients, which is consistent with the low incidence of immunogenicity (0.4%) seen with secukinumab in patients with plaque psoriasis.1

References:

  1. Reich et al, Br J Dermatol. 2017;176:752

Table. Overview of patients with ADAb1

Study

Secukinumab

dose

Prior biologics

ADAbs (titer)/ Neut-Ab

Immunogenicity-related AE

Impact on efficacy2

Pharmacokinetics behavior3

PsA trials

F2306

PBO-

75 mg

0

Wk24 (no titer)/Y

N

None

Normal

F2312

PBO-150 mg

0

Wk52 (2.99)/N

N

None

Normal

F2318

150 mg

Infliximab

Wk52 (2.14)/N

N

None

Normal

150 mg

0

Wk24 (1.00)/N

N

None

Normal

150 mg

0

Wk52 (2.59)/N

N

None

Normal

AS

trials

F2305

10mg/kg–150 mg

0

Wk52 (2.39)/N

N

None

Normal

PBO-150 mg

0

Wk52 (10.61)/N

N

None

Normal

F2310

PBO-75 mg

0

Wk52 (39.39)/N

N

None

Normal

F2314

PBO-300 mg

0

Wk52 (1.02)/N

N

None

Normal

F2320

150 mg

0

Wk16 (6.35)/N W52/(2.96)/N

N

None

Normal

150 mg No Load

0

Wk16 (2.70)/N

N

None

Normal

150 mg

0

Wk24/(2.80)/N

N

None

Normal

PBO–150 mg

0

Wk52/(2.89)/N

N

None

Normal

Neut-Ab=neutralizing antibodies; N, No; PBO, placebo; Y, yes; Wk, week. 1Only positive ADAb results at the respective study wk are shown; 2Impact on efficacy is defined as: PsA, failure to achieve >20% reduction, compared to baseline, in both tender and swollen joint counts; AS, failure to achieve ASAS20, after previously achieving such improvement for at least 2 consecutive visits prior to the first detection of ADAb; 3Normal PK: Concentrations in ADAb-positive patients within observed range for all patients without ADAb


Disclosure: A. A. Deodhar, AbbVie Inc., Eli Lilly, GSK, Janssen, Novartis, Pfizer Inc., and UCB, 2,AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, 5; D. D. Gladman, Amgen, AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, 2,Amgen, AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, 5; I. B. McInnes, Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, 2,Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, 5,Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, 8; V. Strand, AbbVie, Amgen, BMS, Celgene, Celltrion, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Sandoz and UCB., 5,AbbVie, Amgen, BMS, Celgene, Celltrion, Genentech, Janssen, Merck, Novartis, Pfizer, Sandoz and UCB., 9; M. Ren, Novartis, 3; S. Spindeldreher, Novartis, 1,Novartis, 3; L. Pricop, Novartis, 1, 3; B. Porter, Novartis, 1, 3; J. Safi, Novartis, 1,Novartis, 3; A. Shete, Novartis, 1, 3; G. Bruin, Novartis, 1,Novartis, 3.

To cite this abstract in AMA style:

Deodhar AA, Gladman DD, McInnes IB, Strand V, Ren M, Spindeldreher S, Pricop L, Porter B, Safi J, Shete A, Bruin G. Secukinumab Immunogenicity in Patients with Psoriatic Arthritis and Ankylosing Spondylitis during a 52-Week Treatment Period [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/secukinumab-immunogenicity-in-patients-with-psoriatic-arthritis-and-ankylosing-spondylitis-during-a-52-week-treatment-period/. Accessed .
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