Psoriasis is a common, chronic, relapsing inflammatory disease with a prevalence of around 2% in the Spanish population.1 It can be associated with psychiatric and physical comorbidities such as obesity and metabolic syndrome.2

Biological treatments have revolutionized the management of psoriasis, showing high efficacy and safety.3 Treating obese patients is more challenging, as treatment efficacy is usually lower in these patients.

Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that selectively targets the IL-17RA subunit, inhibiting the biologic activity of several proinflammatory cytokines.4 Its efficacy and safety were demonstrated in the AMAGINE trial and in some real-life studies.5–8

Therefore, we present this study, which aims to evaluate the safety and effectiveness of brodalumab in real-world practice for patients with moderate-to-severe psoriasis in a Spanish hospital and to compare the treatment response in obese (BMI≥30) vs non-obese patients.

We conducted a prospective observational study of patients who consecutively attended our psoriasis unit and began treatment with brodalumab for moderate-to-severe psoriasis from May 2020 to May 2021.

All patients received brodalumab according to the recommendations in the datasheet. We made no changes to the dosage or frequency of drug administration based on efficacy parameters or according to patient weight.

Patients’ clinical data were collected at consecutive visits and included age, sex, height, weight, body mass index (BMI), disease duration, comorbidities, and prior treatments (conventional systemic and biologic). Patients with a BMI≥30 were considered obese.

Disease severity and treatment response were measured by dermatologists using the Psoriasis Area and Severity Index (PASI) scale, assessed at the first visit before starting treatment and at weeks 4, 12, 24, and 52. We used the clinical interview to record any adverse effects that occurred during treatment.

Data were analyzed using Microsoft Excel Professional Plus 2019 and SPSS version 26.

This study was carried out in compliance with the provisions of Spanish Organic Law 15/99 on the Protection of Personal Data and the Declaration of Helsinki on Ethical Principles for Medical Research involving Human Subjects and was approved by the local Ethics Committee (1395-N-22).

Thirty-three patients were enrolled. Table 1 shows the patients’ baseline characteristics. All patients had received previous treatment for psoriasis. Nine patients (27.3%) were biologic-naive, while 24 patients (72.7%) were receiving biologic therapy. Eleven of these had been treated with 2 or more different biologics. The mean number of previous biologic treatments received was 1.30 (median, 1; IQR, 2). Twelve patients (36.4%) had been treated with anti-TNF, 11 (33.3%) with anti-IL-17, and 13 (39.4%) with anti-IL-12/23.

Efficacy results are shown in Table 2 and illustrated in Fig. 1. Treatment had to be discontinued in only 2 patients, 1 at week 12 due to ineffectiveness and the other at week 24 due to loss to follow-up. Therefore, week 12 was reached by 32 patients, while weeks 24 and 52 were reached by 31 patients.

Fig. 1.

Mean PASI at the follow-up.

There were no statistically significant differences between PASI 75, PASI 90, PASI 100 response, and absolute PASI<5 and <3 at weeks 4, 12, 24, and 52 of follow-up between obese and non-obese patients. At week 12, a PASI 100 response was obtained in 58.3% of non-obese patients and 31.6% of obese patients, while at week 24 the PASI 100 response was 54.5% vs 47.4%, respectively.

Only 2 patients experienced mild adverse effects from the treatment (asthenia a few hours after drug administration), which did not require discontinuation of the drug.

In our study, brodalumab efficacy in patients with moderate-to-severe psoriasis was comparable to that reported in published clinical trials. In AMAGINE-1, 83% of patients achieved PASI 75 at week 12 compared with 87% in our series.9 In AMAGINE-2 and -3, 678 patients (281 obese) were included. At week 12, 54.1% of non-obese and 49.5% of obese patients achieved PASI 100, without statistically significant differences between groups. Similarly, in our study, at week 12 we obtained a PASI 100 response in 58.3% of non-obese patients and 31.6% of obese patients. Discrepancies in obese patient percentages may be explained by differences in sample size and controlled clinical trial conditions vs real-world settings.10

Tampouratzi et al. have published the largest real-life study to date (180 patients) with the longest follow-up (24 months).8 Baseline characteristics were similar to ours, although with a lower percentage of patients previously treated with biologics (41.67% vs 72.7%) and a lower previous BMI (28.52 vs 32.44). In terms of efficacy data, they obtained a PASI 75 and PASI 90 response of 86.7% (vs 87%) and 70.7% (vs 70%), respectively, at week 52.

Our results support the efficacy profile of brodalumab characterized by a rapid response sustained over time. This is in line with other published studies with the same or longer follow-up period.6,8

Our study's limitations include an open design and a small sample size, highlighting the need for larger real-world studies. Its strengths lie in the prospective design including obese patients previously treated with biologics, the follow-up time, and being the first series comparing treatment response in obese vs non-obese patients in real-world clinical practice.

In conclusion, brodalumab is an effective biologic with a rapid response and a good safety profile for the treatment of patients with moderate-to-severe psoriasis. It may be a good therapeutic choice for obese patients, as it maintains adequate efficacy (similar to that observed in non-obese patients) without the need for an increase in dosage.