Malignancy Risk Low in Secukinumab Treatment

Mark Lebwohl, MD (Mount Sinai)

A recent study determined a low risk of malignancy in secukinumab for the treatment of diseases such as psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS), for up to 5 years of care.

Limited data on long-term studies regarding the use of the biologic therapy led investigators to assess the malignancy risk, led by Mark Lebwohl, MD, of Mount Sinai.

Despite previous trials indicating a possible association between secukinumab and malignancy, the long-term recurrence of the outcome was relatively infrequent, and did not increase over time.

Investigators studied the history of malignancy risk in secukinumab-treated patients, as well as the current risk in patients. Safety data was collected from secukinumab-treated patients including 10,685 with psoriasis, 2523 with PsA and 1311 with AS (n = 14,519) from 49 clinical trials.

The study safety analyses used a malignancy rate evaluation using exposure-adjusted incidence rates (EAIR) and standardized incidence ratios (SIR) using the Surveillance, Epidemiology, and End Results Program (SEER) as a reference point.

Over a five-year period, the EAIR malignancy rate in secukinumab-treated patients was 0.85/100 patient-treatment years (PTY; 95% CI, 0.74-0.98). This data corresponds to 204 patients and 23,908 PTY.

The estimate cumulative incident reporting rate was 0.27/100 PTY for malignancy in the post-marketing surveillance data, with an exposure of 285,811 PTY. An external reference population was needed as a comparative arm for observed rate and occurrence, so investigators used the general US population.

Under 2% (n = 242)of clinical trial patients had a medical history of malignancy (psoriasis, n = 168; PsA, n = 60; AS, n = 14).

The percentage of both male and female patients were comparable; 94% were white and 60% were European.

The trial population had 25 patients who reported a medical history of malignancy on secukinumab treatment (psoriasis, n = 20; PsA, n = 4; AS, n = 1).

A minority of patients (n = 38) during the clinical trial observation period reported multiple malignancies (psoriasis, n = 27; PsA, n = 10; AS, n = 1). None of the malignancy cases were lymphomas, with over half being skin cancers and the majority non-melanoma skin cancer.

Investigators believe the five-year outcomes were as expected, based on previous clinical trial data. Past trials have been inconsistent in determining the overall risk of malignancy, but the observed rate of malignancy is comparable to those expected in the general US population (SIR = 0.99; 95% CI, 0.82 - 1.19).

“The risk of malignancy events did not appear to be increased compared to the reference population for up to five years of secukinumab treatment,” investigators wrote. “Additionally, reoccurrence of malignancy and multiple malignancies occurred relatively infrequently, and the rate of malignancy did not increase over time.”

They concluded that the data supports the long-term use of secukinimab in these treatment indications.

The study, “The risk of malignancy in secukinumab‐treated psoriasis, psoriatic arthritis and ankylosing spondylitis patients: analysis of up to five‐year clinical trial and post‐marketing surveillance data,” was published online in the British Journal of Dermatology.