Dose interval shortening of secukinumab therapy from every 4 weeks to every 2 weeks may improve skin clearance rates in patients with moderate to severe plaque psoriasis who experienced suboptimal therapeutic response, according to findings from the GAIN clinical trial, published in the British Journal of Dermatology.
The multicenter, double-blind, randomized trial (ClinicalTrials.gov identifier NCT02474069) enrolled a total of 772 adult patients with moderate to severe plaque psoriasis from Germany. Patients received 300 mg secukinumab once weekly for 4 weeks. Following this 4-week treatment schedule, 300 mg secukinumab was then administered every 4 weeks until 16 weeks.
At week 16, patients who were considered suboptimal responders — those who achieved Psoriasis Area and Severity Index (PASI)≥75 to PASI<90 by 16 weeks — were randomly assigned 1:1 to receive either 300 mg secukinumab every 4 weeks (n=162) or 300 mg secukinumab every 2 weeks (n=163). In this randomization phase, patients received treatment for an additional 16 weeks. Both groups were compared in terms of the percentage of patients who achieved a PASI<90 response by week 32.
Overall, patients had a mean baseline PASI of 23.1±10.5. At week 32, a greater percentage of patients treated with secukinumab 300 mg every 2 weeks achieved PASI<90 compared with patients treated with secukinumab 300 mg every 4 weeks (64.4% vs 57.4%, respectively), yet no significant difference was observed (odds ratio [OR], 0.64; 95% CI, 0.39-1.07; P =.087). The primary endpoint — superiority of treatment every 2 weeks compared with treatment every 2 weeks — was not met during the study.
Patients in the 2-week dosing arm had a significantly lower absolute PASI at week 32 compared with patients who received dosing every 4 weeks (2.14 vs 2.81; P =.024). In addition, a greater percentage of patients treated with secukinumab 300 mg every 2 weeks showed minimal disease activity (71.2% vs 61.7%) and had improved quality of life (58.9% vs 50.5%) by 32 weeks. There were no new or unexpected safety signals during treatment.
Limitations of the GAIN study included the short treatment duration and the lack of assessment of costs related to treatment and optimal duration of increased dose frequency in a real-world setting.
The study creates additional questions, and the investigators suggest that “further studies are required to establish the utility of flexible dosing with the [every 2 week] regimen.”
Disclosure: This clinical trial was supported by Novartis. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Reich K, Körber A, Mrowietz U, et al. Secukinumab two weekly versus four weekly dosing in patients with plaque-type psoriasis: results from the randomized GAIN study [published online July 11, 2020]. Br J Dermatol. doi: 10.1111/bjd.19398