Prior Use of Biologics, Adalimumab Help Predict HS Biologic Treatment Intensification

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Previous utilization of biologic therapies and the biosimilar adalimumab are significant predictors of hidradenitis suppurativa (HS) treatment intensification, according to new findings, indicating a need for closer monitoring for certain types of patients’ treatment outcome optimization.¹

These findings resulted from new retrospective research conducted to determine the probability of biologic treatment intensification for those with moderate-to-severe HS, an often debilitating immune-mediated skin condition. This research was led by Francisco Javier Melgosa Ramos of the department of dermatology at the Hospital Lluís Alcanyís in Spain.

Ramos et al. noted that despite the benefits of targeted treatments being introduced early, certain primary responders may see a loss of drug response, necessitating off-label intensification.²

“However, it is not well-established which factors may increase the probability of intensification,” Ramos and colleagues wrote. “The aim of this study is to identify potential predictors of biological therapy intensification in moderate-to-severe hidradenitis suppurativa.”¹

Background and Design

In the period between June 2020 - June 2024, multiple centers were used to conduct the investigators’ retrospective, non-interventional study. Specifically, the work was done in the dermatology departments of 2 Spanish hospitals, with the research team looking at individuals diagnosed with moderate-to-severe HS who were also being treated with biologics in routine clinical settings.

In terms of primary aims, the team sought to determine the factors that could predict the need for intensifying patients’ biologic therapies. The International Hidradenitis Suppurativa Severity Score System (IHS4), the Hurley stage, and the Physician Global Assessment (PGA) for HS were implemented for the purposes of assessing disease severity in subjects.

Study participants being treated with biologics were placed into 1 of 2 cohorts: patients in need of intensified treatment and patients placed on standard dosing regimens. The investigators defined therapy intensification as administering the drugs at intervals shorter than those recommended on the product label.

In order to characterize those in their subject cohort, the researchers utilized the Shapiro–Wilk test. Descriptive statistical methods were applied and quantitative data were reported as means with standard deviations (SD).

Qualitative data were presented by the investigators as relative frequencies. The research team used univariate statistical methods to assess distinctions between the 2 patient cohorts.

A multivariate logistic regression analysis also helped the team to further identify elements linked to treatment intensification. It would incorporate variables found to be significant or clinically relevant in the aforementioned univariate analysis, with a P-value of less than .05 determined to be statistically significant.

Main Findings

Overall, 102 individuals were included in the analysis, with 26.48% being placed into the intensified therapy arm of the study and 73.52% placed into the non-intensified arm. 93.3% of the subjects being given intensified therapy were treated with adalimumab 80 mg at intervals of 5–10 days.

The investigators noted that only 6.7% with intensified therapy were given secukinumab 300 mg every 10 days. In their univariate analysis, the researchers determined that there therapy intensification increases were associated with 3 other factors: elevated baseline IHS4 scores (P = .008), increased numbers of previous biologic treatments (P = .002), and implementation of biosimilar drugs (P = .035).

They found that other factors, including family history, smoking habits, and comorbid conditions such as Crohn's disease and cardiovascular risk factors, were not shown to have significant associations with intensification. The research team did, however, observe that the presence of different types of autoimmune conditions like SAPHO syndrome, psoriasis, or spondyloarthritis approached significance (P = .08).

During their multivariate analysis, it was determined that use of the biosimilar adalimumab (P = .040) as well as a greater number of prior biologics (P = .019) were found to be independently linked to a rise in likelihood of intensified dosing.

“The limitations of our study include the small number of patients and potential differences in the measurement of variables across the different centres,” they wrote. “Randomised controlled studies are required to confirm these findings.”¹

References

1. ^{Melgosa Ramos, F.J., García Ruiz, R. and Martorell, A. (2025), Potential Predictors of Biological Therapy Intensification in Moderate-To-Severe Hidradenitis Suppurativa: A Multicentre Study. Australas J Dermatol. https://doi.org/10.1111/ajd.14412.}
2. ^{C. C. Zouboulis, H. Hansen, R. D. Caposiena Caro, et al., “Adalimumab Dose Intensification in Recalcitrant Hidradenitis Suppurativa/Acne Inversa,” Dermatology 236, no. 1 (2020): 25–30.}