Post-Marketing Safety of Secukinumab in Adult Patients with Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Cumulative Analysis across >96,000 Patient-Treatment Years Exposure

Atul A. Deodhar¹, Dafna D Gladman², Iain B. McInnes³, Filip van Den Bosch⁴, Abhijit Shete⁵, Ruquan You⁶, Samina Hussain⁷ and Jorge Safi⁸, 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, ⁴Rheumatology, Ghent University Hospital and VIB Ghent University, Gent, Belgium, ⁵Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland, ⁶Shanghai Novartis Trading Limited, Shanghai, China, ⁷Novartis Healthcare Private Limited, Hyderabad, India, ⁸Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adverse events, Biologics, interleukins (IL), monoclonal antibodies and safety

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 that selectively neutralizes IL-17A, is currently approved in >75 countries for use in psoriasis /psoriatic arthritis and ankylosing spondylitis with over 150,000 patients treated. Pooled safety data for secukinumab from clinical trials in >7350 patients representing >16,000 patient-treatment years (PY) exposure demonstrated a consistent safety profile.^1,2 Post-marketing data is considered complementary to data from randomized clinical trials (RCTs); here we report cumulative post-authorization safety data for secukinumab from ongoing periodic safety update reports (PSUR).

Methods: We report the cumulative number of cases along with patient-treatment exposure and exposure-adjusted reporting rates (EARR) across 5 successive PSUR periods covering Dec 26, 2014 to June 25, 2017 for the following adverse events: infections, neutropenia, hypersensitivity, malignant and unspecified tumors, major adverse cardiac events (MACE), inflammatory bowel disease (IBD), immunogenicity, hepatitis B reactivation and interactions with live vaccines.

Results: The cumulative post-marketing exposure to secukinumab was estimated to be ~96,054 PY across the approved indications. Overall EARRs are summarized in the Table. EARR for infections and serious infections were 4.7 and 1.8 per 100 PY, respectively. Neutropenia was reported at the rate of 0.07 per 100 PY. Hypersensitivity reporting rate was 2.4 per 100 PY. EARR for malignancies and MACE were both 0.2 per 100 PY with most assessable cases having multiple confounders, risk factors, or alternative explanations for the events. Total IBD was reported at the rate of 0.2 per 100 PY. There was one case of immunogenicity, and no cases of either hepatitis B reactivation or interactions with live vaccines reported. The safety profile from the PSUR was consistent to that reported in RCTs with secukinumab.^1,2

Conclusion: Secukinumab was associated with a consistent safety profile in the post-marketing setting across the approved psoriasis, psoriatic arthritis and ankylosing spondylitis indications. There were no new or changing safety signals reported in successive PSUR periods.

References:

Deodhar, et al. Arthritis Rheumatol. 2017; 69 (S10). [Abstract Number: 1529]
Mease, et al. Arthritis Rheumatol. 2017; 69 (S10). [Abstract Number: 606]

Table. Summary of secukinumab post-marketing safety: Cumulative and across 5 PSUR periods

Reporting period	26 Dec 14 – 25 June 15	26 June 15 – 25 Dec 15	26 Dec 15 – 25 June 16	26 June 16 – 25 Dec 16		26 Dec 16 – 25 June 17	Cumulative rate
Exposure (PY)	1,838	7,450	16,871	28,549		41,346	96,054
Infections and infestations/Serious infections
Cases (n)	178/89	495/149	712/232	1136/475	1730/573		4,483/1,688
EARR (per 100 PY)	9.7/4.8	6.6/2.0	4.2/1.4	4.0/1.7	4.2/1.4		4.7/1.8
Neutropenia
Cases (n)	0	11	12	22	24		66
EARR (per 100 PY)	0	0.2	0.07	0.08	0.06		0.07
Hypersensitivity
Cases (n)	82	293	425	573	752		2,293
EARR (per 100 PY)	4.5	3.9	2.5	2.0	1.8		2.4
Malignant or unspecified tumors
Cases (n)	2	15	21	50		76		173
EARR (per 100 PY)	0.1	0.2	0.1	0.2		0.2		0.2
Total IBD
Cases (n)	4	12	37	46		93		195
EARR (per 100 PY)	0.2	0.2	0.2	0.2		0.2		0.2
MACE
Cases (n)	6	15	16	39		58		148
EARR (per 100 PY)	0.3	0.2	0.09	0.1		0.1		0.2
Approximation was not done if EARR is less than 0.1 EARR, exposure-adjusted reporting rates; IBD, inflammatory bowel disease; MACE, major adverse cardiac events; PSUR, periodic safety update report; PY, patient-treatment years

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; F. van Den Bosch, AbbVie, BMS, Celgene, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer and UCB, 2, 5, 8; A. Shete, Novartis, 1, 3; R. You, Novartis, 3; S. Hussain, Novartis, 3; J. Safi, Novartis, 1,Novartis, 3.

To cite this abstract in AMA style:

Deodhar AA, Gladman DD, McInnes IB, van Den Bosch F, Shete A, You R, Hussain S, Safi J. Post-Marketing Safety of Secukinumab in Adult Patients with Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Cumulative Analysis across >96,000 Patient-Treatment Years Exposure [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/post-marketing-safety-of-secukinumab-in-adult-patients-with-psoriasis-psoriatic-arthritis-and-ankylosing-spondylitis-cumulative-analysis-across-96000-patient-treatment-years-exposure/. Accessed .

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