PSSI, NAPSI, which was maintained up to 5 years, while slightly less improvement up to 5 years was evident for PPASI (Figure 3). Up to 80% of patients reported DLQI (0,1) response at week 12, which was sustained through week 264 for patients in each of the three burdensome areas (Figure 4).
Safety
Safety in each subpopulation was consistent with the safety in the general trial population which has been previously described.15,16 No deaths were reported through year 5. The incidence rates of TEAEs and SAEs were generally consistent through year 5 in patients with scalp, nail, or palmoplantar psoriasis, and most TEAEs were of mild or moderate severity (Table 2). Pre-defined categories of TEAEs of special interest considering all patients were infection, cytopenias, hepatic, injection site reaction, and allergic reaction/hypersensitivity (anaphylaxis, non-anaphylaxis). Incidence rates across the three patient populations were generally consistent with previous reports of the overall IXE Q2W/IXE Q4W population during the long-term extension period for infection (25.2 – 28.2 per 100 patient years), cytopenias (0.8-2.1), and hepatic TEAEs (2.5-4.1). Allergic reaction/hypersensitivity (non-anaphylaxis) incidence rates ranged from 4.7 to 6.2 per 100 patient years and no events of anaphylaxis were reported. Injection site reactions were also consistent (1.6-3.4) with previously published IRs (data not shown.16
DISCUSSION
The long-term efficacy and safety of IXE in patients with moderate-to-severe psoriasis is well established through 5 years.13,15,16 IXE demonstrated significant responses in patients with burdensome types of psoriasis in the UNCOVER-1, UNCOVER-2, and UNCOVER-3 studies up to week 60,3,7,8,17 and in UNCOVER-3 up to 5 years. Our analyses integrated UNCOVER-1 and UNCOVER-2 data to report efficacy and safety in patients with baseline scalp, nail, or palmoplantar psoriasis and adds to this body of data supporting long-term IXE treatment. These findings indicate that IXE maintained up to 5 years of high rates in improvement of scalp, nail and palmoplantar psoriasis and QOL.
Scalp psoriasis occurs frequently in patients with psoriasis and is associated with symptoms that negatively effect social activities due to the visibility of lesions and itching.18 Here, we report that more than 90% of patients with baseline scalp psoriasis had symptom improvement at week 24, which was maintained for up to 5 years, and up to 80% of patients had no impact of symptoms on QoL. Response rates with IXE for up to 5 years in patients with scalp psoriasis were consistent with those previously reported at 60 weeks.8
Due to the slow rate of nail growth, a longer duration of treatment of patients with nail psoriasis for optimal response is required.5,19
Scalp psoriasis occurs frequently in patients with psoriasis and is associated with symptoms that negatively effect social activities due to the visibility of lesions and itching.18 Here, we report that more than 90% of patients with baseline scalp psoriasis had symptom improvement at week 24, which was maintained for up to 5 years, and up to 80% of patients had no impact of symptoms on QoL. Response rates with IXE for up to 5 years in patients with scalp psoriasis were consistent with those previously reported at 60 weeks.8
Due to the slow rate of nail growth, a longer duration of treatment of patients with nail psoriasis for optimal response is required.5,19
