Secukinumab improves psoriasis symptoms in patients with inadequate response to cyclosporine A: A prospective study to evaluate direct switch

Abstract

There are limited data on the safety and efficacy of switching to secukinumab from cyclosporine A (CyA) in patients with psoriasis. The purpose of the present study was to assess the efficacy and safety of secukinumab for 16 weeks after direct switching from CyA in patients with moderate‐to‐severe psoriasis. In this multicenter, open‐label, phase IV study, 34 patients with moderate‐to‐severe psoriasis and inadequate response to CyA received secukinumab 300 mg s.c. at baseline and weeks 1, 2, 3, 4, 8 and 12. The primary end‐point was ≥75% improvement from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 16. The efficacy of secukinumab treatment was evaluated up to week 16, and adverse events (AE) were monitored during the study. The primary end‐point of the PASI 75 response at week 16 was achieved by 82.4% (n = 28) of patients receiving secukinumab. Early improvements were observed with secukinumab, with PASI 50 response of 41.2% at week 2 and PASI 75 response of 44.1% at week 4. AE were observed in 70.6% (n = 24) of patients, and there were no serious AE or deaths reported in the entire study period. Secukinumab showed a favorable safety profile consistent with previous data with no new or unexpected safety signals. The results of the present study show that secukinumab is effective in patients with psoriasis enabling a smooth and safe direct switch from CyA to biological therapy.

Long‐term clinical efficacy and safety of secukinumab for Japanese patients with psoriasis: A single‐center experience

“…Furthermore, we demonstrated the benefit of bio‐switch from tumor necrosis factor (TNF)‐α antagonists or IL‐12/23 p40 antagonist, in accordance with the result of a randomized clinical trial in Japan . However, in the postmarketing study to evaluate efficacy of direct switching to secukinumab from cyclosporin, response rates were lower in patients previously exposed to other biologics . In our observation, direct bio‐switched patients showed numerically higher response rates than bio‐naive patients.…”

“…6 However, in the postmarketing study to evaluate efficacy of direct switching to secukinumab from cyclosporin, response rates were lower in patients previously exposed to other biologics. 8 In our observation, direct bio-switched patients showed numerically higher response rates than bio-naive patients. Although the reason for this Week-0…”

Japanese guidance for use of biologics for psoriasis (the 2019 version)

“…When patients were switched from cyclosporin to biologic therapy in Japanese clinical studies with infliximab, PASI scores were decreased rapidly without worsening of psoriasis, even when cyclosporin was withdrawn immediately before switching, and there were no noteworthy safety problems. It has also been suggested that direct switching from cyclosporin to secukinumab is possible . Regarding the other biologics, co‐administration with cyclosporin for several weeks (2–8 weeks) is useful for smooth drug switching only in cases where symptoms may relapse at the time of switching from cyclosporin, and this is also described in the guidelines in Europe and the USA.…”

“…Table 1 shows the list of biologics available for psoriasis in Japan. In the References section, the following are listed as sources for efficacy and safety data in pivotal studies of each biologic in and outside of Japan and for the results of Japanese post-marketing surveillance of each biologic: infliximab, [7][8][9][10][11][12][13][14][15][16] adalimumab, 17-23 ustekinumab, 24-32 secukinumab, [33][34][35][36][37][38][39][40][41][42] ixekizumab, [43][44][45][46][47][48] brodalumab, [49][50][51][52][53][54] guselkumab, 55-61 risankuzumab 62-64 and infliximab BS. 65,66 Additional note: Psoriasis arthropathica and psoriatic arthritis.…”

“…It has also been suggested that direct switching from cyclosporin to secukinumab is possible. 38 Regarding the other biologics, co-administration with cyclosporin for several weeks (2-8 weeks) is useful for smooth drug switching only in cases where symptoms may relapse at the time of switching from cyclosporin, and this is also described in the guidelines in Europe and the USA. However, when drugs are administrated in combination, it is necessary to consider the patient's age and other background factors carefully, to explain about the risks of infections thoroughly to patients and to monitor the course carefully.…”