Background/Purpose: Secukinumab, a fully human anti–interleukin-17A
monoclonal antibody, has been shown to improve the signs and symptoms of
psoriasis and psoriatic arthritis (PsA).^1–3 Here, we describe
the safety profile of secukinumab from a large cohort
of patients (pts) with psoriasis (PsO) and pts with
psoriatic arthritis (PsA), using pooled data from phase 3 studies.

Methods: Safety data were pooled from five double-blind, randomized, placebo
(PBO)-controlled phase 3 studies in pts with PsO (ERASURE
[NCT01365455], FIXTURE [NCT01358578], SCULPTURE [NCT01406938], FEATURE
[NCT01555125] and JUNCTURE [NCT01636687]), and two double-blind, randomized,
PBO-controlled, phase 3 studies in pts with active PsA (FUTURE 1 [NCT01392326] and FUTURE 2
[NCT01752634]).
In the FUTURE 1 study, pts received 10 mg/kg secukinumab i.v.
loading followed by s.c.
maintenance dosing (75 mg or 150 mg). In all other studies pts received s.c. loading and maintenance with
secukinumab (300, 150, or 75 mg). All randomized pts were included in the pooled safety
analysis. Data were pooled at the patient level, and safety analyses were
performed for the entire treatment period (≥ 52 weeks for FUTURE 1; Week
52 for ERASURE, FIXTURE, SCULPTURE, FEATURE and JUNCTURE; ≥ 24 weeks for
FUTURE 2)

Results: 3928 pts received ≥1 dose of secukinumab (3225 pt-years of exposure,
respectively). Baseline
demographics, disease/medical history and concomitant medications were similar
between the pooled secukinumab and PBO populations. Exposure-adjusted incidence rates for AEs/SAEs across the entire safety
period (mean exposure: 299.8 days secukinumab; 105.7 days PBO) were, 240.5/7.9
and 329.6/9.9 per 100 pt-years with secukinumab and
PBO, respectively; 115 (2.9%) pts discontinued secukinumab treatment due to
AEs. There were four deaths in secukinumab-treated pts: one due to intracranial
hemorrhage; one due to cardio-respiratory
arrest; one due to alcohol intoxication; and one of unknown cause.
There were two (0.05%) cases of suicidality with secukinumab; one attempted
suicide and one case of suicidal ideation. Nasopharyngitis
and upper respiratory tract infections were the most frequently reported AEs
with secukinumab. The incidence of inflammatory bowel disease (IBD)/Crohn’s, infections, neutropenia, major adverse cardiac events (MACE)
and malignancy with secukinumab was low (Table).

Conclusion: Secukinumab was well tolerated in a large cohort of 3928 patients
across 7 phase 3 studies with PsA and PsO. The safety
profile was consistent with previous reports.

References

1. Mease P, et al. Arthritis
Rheumatol. 2014;66:S423–4.

2. Mclnnes IB, et al. ACR/ARHP Annual Meeting,
Boston, MA, USA.
November 14-19, 2014. Oral Presentation L1.

3. Langley RG et al. N Engl J Med. 2014;371:326–38