Ixekizumab delivers safe outcomes in patients with psoriasis
Maintenance with ixekizumab does not result in unexpected safety signals in patients with psoriasis, highlighting its acceptable safety profile, a recent study has found.
Integrated safety data were obtained from a 12-week induction period, a 12- to 60-week maintenance period and all ixekizumab-treated patients from seven clinical trials to assess the safety of the study drug in psoriasis. Exposure-adjusted incidence rates (IRs) per 100 patient-years were reported.
“With 6,480 patient-years of exposure in 4,209 patients, we evaluated long-term continuous follow-up in one of the largest cohorts of patients with psoriasis treated with an anti–[interleukin]-17A monoclonal antibody in a clinical trial setting,” researchers said.
“Most observed AEs (adverse events) were nonserious and did not lead to treatment discontinuation,” they added.
The IRs of patients with one or more treatment-emergent AE during the induction period were 251 among ixekizumab-treated patients and 236 among those who received etanercept. Meanwhile, the IR for serious AEs was 8.3 in both groups. Additionally, both groups had comparable IRs of individual serious AEs and discontinuations due to AEs. [J Am Acad Dermatol 2017;76:432–440.e17]
There were no reported deaths during the induction period, according to researchers.
During maintenance, the respective IRs of treatment-emergent AEs and serious AEs for ixekizumab were 100.4 and 7.8. Candida infections had an IR of 2.5 among all ixekizumab-treated patients from seven trials.
Both ixekizumab and etanercept had similar IRs of treatment-emergent AEs of special interest, including serious infections, malignancies, and major adverse cardiovascular events, during the induction period. Cellulitis (n=17) was the most common serious infection in the All Psoriasis Ixekizumab Exposures Analysis Set.
“Cellulitis is typically caused by infection with Streptococcus pyogenes or Staphylococcus aureus,” researchers said. “Patients with deficiency with T helper 17 (Th17) cells (hyper-IgE syndrome [HIES]), IL-17RA, or IL-17F have increased risk of cutaneous infection because of Staphylococcus aureus.” [Science 2011;332:65–68; Eur J Immunol 2012;42:2246–2254]
“It is not unexpected that cellulitis is the most frequent serious infection observed in ixekizumab-treated patients,” they added.
Furthermore, patients with psoriasis who received ixekizumab had a suicidal ideation or behaviour rate of 1.39 per 1,000 patient-years, which is within the range reported for patients with psoriasis.
“Ixekizumab-treated patients, compared with etanercept- and placebo-treated patients, did not show evidence of an increased risk of suicidal thoughts and behaviors,” researchers said.
Suicide attempts were reported in eight patients in the All Psoriasis Ixekizumab Exposures Analysis Set. Only those with one or more risk factors attempted suicide. In patients treated with placebo and etanercept, depression- and self-injury‒related events also occurred.
Additional long-term data are warranted to confirm these findings, according to researchers.