ABSTRACT
INTRODUCTION: Psoriasis, an incurable chronic inflammatory disease, affects over 6 million people in China. Ixekizumab, a monoclonal antibody against interleukin-17A, has demonstrated efficacy and safety for the treatment of moderate-to-severe plaque psoriasis, although limited data are available regarding its use in routine clinical practice in China. We investigated the real-world application of ixekizumab in China. METHODS: Adults (≥ 18 years) with moderate-to-severe plaque psoriasis prescribed ixekizumab in routine clinical practice were enrolled in this prospective, observational, single-arm, multicenter, post-marketing surveillance study. The primary endpoint was the safety of ixekizumab at week 12. The effectiveness of ixekizumab, based on the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI), was assessed as a secondary endpoint. RESULTS: In total, 666 patients were enrolled; 663 were included in the safety analysis, and 612 in the effectiveness analysis. At least one adverse event (AE) was reported by 42.7% (283/663) of patients, most of which were mild (242/283, 85.5%), and 32.7% (217/663) of patients reported AEs related to study treatment. The most frequently reported AEs were injection site reactions. AEs led to discontinuation in five patients (0.8%). Only three patients had a serious AE. Mean ± standard deviation (SD) change from baseline in PASI score was reduction in 10.79 ± 9.55 at week 2 and 16.80 ± 12.15 at week 12. At week 2, 63.7% of patients achieved PASI 50. At week 12, 93.2%, 77.4%, and 45.1% of patients achieved PASI 75, PASI 90, and PASI 100, respectively. Mean ± SD change from baseline in DLQI was reduction in 5.91 ± 6.27 at week 2 and 9.76 ± 7.16 at week 12. DLQI 0/1 was achieved by 19.8% and 59.9% of patients at week 2 and 12, respectively. CONCLUSION: Ixekizumab was well tolerated and effective in real-world clinical practice in Chinese adults with moderate-to-severe plaque psoriasis.
Subject(s)
East Asian People , Psoriasis , Humans , Adult , Prospective Studies , Treatment Outcome , Severity of Illness Index , Psoriasis/drug therapyABSTRACT
Objective To investigate changes in serum levels of antinuclear antibody(ANA), anti?double?stranded DNA(dsDNA)antibody and anti?extractable nuclear antigen(ENA)antibody before and after anti?tumor necrosis factor?α(TNF?α)therapy in psoriatic patients. Methods Clinical data obtained from 32 patients with psoriasis were analyzed retrospectively. Of the 32 patients, 13 received intravenous injection of 5 mg/Kg infliximab at week 0, 2, 6 for 3 sessions, then once every 8 weeks(infliximab group), while other 19 received subcutaneous injection of 25 mg etanercept twice every week(etanercept group). The treatments in the 2 groups both lasted more than 3 months. Serum levels of ANA, anti?dsDNA antibody and anti?ENA antibody and changes of clinical symptoms were detected and observed respectively before each treatment in the infliximab group, as well as every 3- 6 months in the etanercept group. The 75%reduction in psoriasis area and severity index(PASI75)and disease activity score of 28 joints(DAS28) were used to evaluate clinical efficacy. Serum levels of ANA, anti?dsDNA antibody and anti?ENA antibody were measured by indirect immunofluorescence(IIF)assay, Western blot analysis combined with enzyme?linked immunosorbent assay(ELISA), and Western blot analysis, respectively. Results After 3?month treatment, the 32 patients achieved clinical remission to different extents. Of 32 patients receiving anti?TNF?αtherapy, 7(21.9%)developed new autoantibodies. Concretely speaking, 4 patients in the infliximab group developed autoantibodies in 8.3 ± 5.1 months, including 3 cases positive for ANA and 3 for anti?ENA antibody. Three patients in the etanercept group developed autoantibodies in 9.0 ± 3.0 months, including 3 cases positive for ANA and 1 for anti?ENA antibody. Conclusion Partial patients with psoriasis may develop autoantibodies after anti?TNF?αtherapy.