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Long‐term efficacy of ixekizumab in erythrodermic and generalized pustular psoriasis patients

Erythrodermic psoriasis and generalized pustular psoriasis (GPP) are severe subtypes of psoriasis. To control these disease activities, intensive systemic treatments, such as retinoids, cyclosporine and biologics reagents, are required. The main biological targets of psoriasis are tumour necrosis factor (TNF)-a, interleukin (IL)-23 and IL-17. Among them, anti-IL-17A antibodies are known to have rapid and strong efficacy; however, the long-term efficacy and safety are remained to be accessed. In the article of Okubo et al., the long-term (>3 years) efficacy and safety of ixekizumab, an anti-IL-17A antibody, were reported in Japanese patients with erythrodermic or GPP. This is a sequential study after a phase 3 trial of ixekizumab (UNCOVER-J) which lasted for 52 weeks. Erythrodermic psoriasis (n = 8) and GPP patients (n = 5) continued 80 mg of ixekizumab every 4 weeks for up to 244 weeks. At Week 52, all recruited patients had achieved Global Improvement Scores (GIS) of improved or resolved. In the erythrodermic psoriasis patients, the improved or remission status was maintained for up to Week 244. The mean PASI scores were 42.8 at baseline, 3.0 at Week 52 and 5.0 at Week 244. Mean improvements in DLQI and Itch NRS scores at Week 12 were sustained through Week 244. No severe treatment-emergent adverse effects (TEAEs) or deaths were reported, but two patients discontinued the study because of TEAEs; one discontinued due to mild abnormal hepatic function at Week 101 (AST and ALT levels were 58 and 139 U/L, respectively), and the other due to a positive mycobacterium tuberculosis test at Week 52. In the GPP patients, no patients had a GIS of unchanged or worsened during the study. The mean PASI scores were 12.8 at baseline, 1.8 at Week 52 and 1.6 at Week 244. Mean improvements in DLQI and Itch NRS scores at Week 12 were sustained through Week 244. No severe TEAEs or deaths were reported, but one withdrew the study as he/she was not able to attend the follow-up visits. This is the first clinical study which confirmed the long-term efficacy and safety of anti-IL-17A antibody, ixekizumab, for the treatment of erythrodermic psoriasis and GPP patients. Ixekizumab controlled these disease activities over 3 years and was well-tolerated, and no new safety concerns were identified. Several limitations of this study must be noted. One is the small sample numbers; only eight erythrodermic psoriasis patients and five GPP patients were enrolled, suggesting that rare TEAE can be overlooked in this study. The other limitation is that only single ethnicity, Japanese, was enrolled in this study. A recent study demonstrated that an Asian population has a Th17-skewed condition in atopic dermatitis patients, implying that immune response in erythrodermic psoriasis patients and GPP patients may also differ among distinct ethnicities. Further clinical studies with higher numbers and multi-ethnicities should address these questions.