Ixekizumab showed a good long-term safety profile with increasing duration of drug exposure with no unexpected safety outcomes and a safety profile that is consistent with previous reports in patients with PsO or PsA.
A favorable risk/benefit profile was seen for ixekizumab in both PsO and PsA at up to 3 years of follow-up.
Previous studies analyzing pooled safety data from trials on ixekizumab in moderate-to-severe plaque psoriasis (PsO) and psoriatic arthritis (PsA) have suggested that the safety profile of ixekizumab is consistent between the two indications, and that continued ixekizumab exposure does not increase the rate of adverse events. [1,2]
The study integrated the safety results from ixekizumab-treated patients from phase 1 and 2 trials and from the global and non-global phase 3 and 4 trials in PsO and PsA (PsO, phase 1: I1F-MC-RHAG, I1F-MC-RHBU; phase 2: I1F-MC-RHAJ; phase 3 (non-global): UNCOVER-A, UNCOVER-J, I1F-US-RHBO, I1F-EW-RHBZ phase 3 (global): UNCOVER-1, UNCOVER-2, UNCOVER-3, IXORA-S, IXORA-Q, IXORA-Peds. PsA phase 3 (global): SPIRIT-P1, SPIRIT-P2, SPIRIT-P3; phase 4 (global): SPIRIT-H2H).
The analysis comprised 19,727.9 patient years (PYs) (17,499.3 PYs for PsO and 2228.6 PYs for PsA)
The most common treatment-emergent adverse events (TEAEs) in PsO (incidence rates (IRs) per 100 PYs) were nasopharyngitis (8.8), upper respiratory tract infections (unspecified: 5.4), and injection site-reaction (3.4).
The most common TEAEs in PsA were nasopharyngitis (9.1), upper respiratory tract infections (unspecified: 8.3), and injection site-reaction (7.0).
The adverse events of special interest are shown in the Table.
The rate of inflammatory bowel disease diagnosis was 0.2 in PsO studies and 0.1 in PsA studies.
Opportunistic infections were limited to oral and esophageal Candida and localized herpes zoster.
Rate of suicide ideation or behavior was 0.1 in PsO studies and <0.1 in PsA studies; there were no suicides in either PsO or PsA studies.
Present disclosure: The presenter has reported relationships with AbbVie, Astellas, Eli Lilly, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., Glaxo Smith and Klein, Novartis, Pfizer, RPharm, Sanofi Genzyme, Vertex.