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Abstract Number: 606

Secukinumab Demonstrates Consistent Safety over Long-Term Exposure in Patients with Psoriatic Arthritis and Moderate to Severe Plaque Psoriasis: Updated Pooled Safety Analyses

Philip J Mease1, Iain B. McInnes2, Kristian Reich3, Peter Nash4, Mats Andersson5, Ken Abrams6, Luminita Pricop6 and Todd Fox5, 1Swedish Medical Center and University of Washington, Seattle, WA, 2University of Glasgow, Glasgow, United Kingdom, 3Dermatologikum Hamburg, Hamburg, Germany, 4University of Queensland, Brisbane, Australia, 5Novartis Pharma AG, Basel, Switzerland, 6Novartis Pharmaceuticals Corporation, East Hanover, NJ

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: anti-TNF therapy, Biologic drugs, Biologics, interleukins (IL) and safety

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Session Information

Date: Sunday, November 5, 2017

Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster I

Session Type: ACR Poster Session A

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

Background/Purpose: Pooled safety data from secukinumab psoriasis (PSO) and psoriatic arthritis (PsA) clinical trial programs after ~1 year of exposure have been reported previously.1, 2 Here, we report updated longer-term safety data of secukinumab exposure from PSO and PsA studies.

Methods: The PSO data pool consisted of 9 Phase III studies in moderate-to-severe plaque PSO and PsA pool consisted of 3 Phase III studies in active PsA. Secukinumab doses differed in the studies and included intravenous (up to 10 mg/kg) or subcutaneous (s.c.; 75–300 mg) loading, followed by s.c. maintenance dosing (300, 150 or 75 mg). Placebo patients were re-randomized to secukinumab at 12–24 weeks depending on study design. Exposure adjusted incident rates (EAIR) were used to adjust for differences in treatment exposure and analyses included all patients who received ≥1 dose of secukinumab.

Results: A total of 3893 and 1380 patients from PSO and PsA studies representing an exposure of 7769.0 and 2841.3 patient years, respectively, were included in this pooled safety analysis. In both PsO and PsA, the most frequently reported adverse events (AEs) with secukinumab were nasopharyngitis, headache, non-serious infections of the upper respiratory tract and arthralgia (Table). The EAIRs of AEs of special interest with secukinumab including serious infections, Candida infections, inflammatory bowel disease, and major adverse cardiac events (Table) were similar in both PSO and PsA indications, and comparable to those reported previously.1,2 No cases of tuberculosis were reported.

Conclusion: Secukinumab demonstrated a favorable safety profile during long term treatment (up to 7769 patient-years of exposure) in patients with moderate-to-severe plaque PSO or PsA consistent with previous reports. Safety was comparable across psoriasis and PsA patients supporting long-term use in these chronic conditions.

References: 1. Van de Kerkhof PC, et al. J Am Acad Dermatol. 2016;75:83–98; 2. Mease PJ, et al. Arthritis Rheumatol. 201567:A2886.

Table: Summary of Secukinumab Safety across PSO and PsA studies: Entire Safety Period

PSO

PsA

Any

secukinumab

N = 3893

Any

secukinumab

N = 1380

Total exposure, patient-years

7769.0

2841.3

Min–max exposure (days)

1–1526

8–1464

Exposure (days), mean (SD)

728.9 (421.9)

752.0 (379.8)

Death, n (%)

7 (0.2)

7 (0.5)

EAIR per 100 Patient-years (95% Cl)

Any AE

196.9 (190.3, 203.6)

162.0 (152.9,171.5)

Any serious AE

7.2 (6.6, 7.8)

7.9 (6.8, 9.0)

Frequent AEs^

Nasopharyngitis

18.2 (17.1, 19.3)

12.8 (11.4, 14.3)

Headache

6.3 (5.7, 6.9)

4.5 (3.7, 5.3)

Upper respiratory tract infection

6.2 (5.6, 6.8)

11.0 (9.7, 12.4)

Arthralgia

5.1 (4.6, 5.6)

3.9 (3.2, 4.7)

AEs of special interest

Serious infections

1.4 (1.2, 1.7)

1.7 (1.2, 2.2)

Candida infections

2.1 (1.8, 2.4)

1.7 (1.3, 2.3)

Inflammatory Bowel Disease

0.3 (0.2, 0.4)

0.4 (0.2, 0.7)  

Crohn’s disease

0.1 (0.0, 0.1)

0.1 (0.0, 0.3)  

Ulcerative colitis

0.2 (0.1, 0.3)

0.1 (0.0, 0.3)

MACE

0.3 (0.2, 0.5)

0.4 (0.2, 0.7)  

^Adverse events in the secukinumab group that occurred with an EAIR of ≥5 during the entire safety period in either of the pooled groups. AE, adverse event; EAIR, exposure adjusted incidence rate per 100 patient-years; MACE, major adverse cardiac event; N, number of patients in the analysis; SD, standard deviation


Disclosure: P. J. Mease, AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, SUN, and UCB, 2,AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, SUN, and UCB, 5,AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, 8; I. B. McInnes, Novartis, Amgen, Janssen, BMS, Pfizer, UCB, AbbVie, Celgene, Lilly, 5; K. Reich, AbbVie, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cliag, Leo, Lilly, Medac, Merck Sharp and Dohme Corp., Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB Pharma, Xenoport, 2,AbbVie, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cliag, Leo, Lilly, Medac, Merck Sharp and Dohme Corp., Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB Pharma, Xenoport, 8; P. Nash, Novartis, Abbvie, Roche, Pfizer, BMS, Janssen, and Celgene, 2,Novartis, Abbvie, Roche, Pfizer, BMS, Janssen, and Celgene, 5,Novartis, Abbvie, Roche, Pfizer, BMS, Janssen, and Celgene, 8; M. Andersson, Novartis Pharma AG, 3; K. Abrams, Novartis Pharmaceutical Corporation, 3,Novartis Pharmaceutical Corporation, 1; L. Pricop, Novartis Pharmaceutical Corporation, 1,Novartis Pharmaceutical Corporation, 3; T. Fox, Novartis Pharma AG, 1,Novartis Pharma AG, 3.

To cite this abstract in AMA style:

Mease PJ, McInnes IB, Reich K, Nash P, Andersson M, Abrams K, Pricop L, Fox T. Secukinumab Demonstrates Consistent Safety over Long-Term Exposure in Patients with Psoriatic Arthritis and Moderate to Severe Plaque Psoriasis: Updated Pooled Safety Analyses [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/secukinumab-demonstrates-consistent-safety-over-long-term-exposure-in-patients-with-psoriatic-arthritis-and-moderate-to-severe-plaque-psoriasis-updated-pooled-safety-analyses/. Accessed .
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