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IS USTEKINUMAB EFFECTIVE IN CROHN'S DISEASE PATIENTS WITH PARADOXICAL SKIN REACTIONS CAUSED BY TUMOR NECROSIS FACTOR-ALPHA INHIBITORS?

Shuhei Hosomi 1, Koji Fujimoto 1, Yumie Kobayashi 1, Rieko Nakata 1, Yu Nishida 1, Masaki Ominami 1, Shusei Fukunaga 1, Koji Otani 1, Noriko Kamata 1, Fumio Tanaka 1, Yasuaki Nagami 1, Koichi Taira 1, Yasuhiro Fujiwara 1

Affiliations

1 Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan

Summary

AI Generated

A retrospective study of 54 Crohn's disease patients found that ustekinumab achieved 90% partial or complete response of skin lesions caused by paradoxical reactions to prior TNF-α inhibitors, with comparable one-year treatment continuation rates to patients without such reactions.

Among 10 patients with paradoxical skin reactions to TNF-α inhibitors, ustekinumab achieved complete response in 50% and partial response in 50%, for a combined 90% response rate across psoriasiform eruptions, folliculitis, palmoplantar pustulosis, and atopic dermatitis exacerbations.
One-year cumulative continuous treatment rates were 70% in the paradoxical reaction group versus 56.3% in the no-reaction group, with no statistically significant difference between groups (P = 0.349).
Cox regression analysis confirmed that history of skin paradoxical response was not associated with ustekinumab sustained efficacy (HR 0.60, P = 0.35), while disease behavior phenotypes B2 and B3 were associated with better outcomes compared to B1.
The study enrolled patients who received ustekinumab as second or third-line biologic therapy between June 2017 and September 2020, with prior exposure to infliximab or adalimumab.
This material is relevant for clinicians managing Crohn's disease patients who develop paradoxical skin reactions to TNF-α inhibitors and are considering therapeutic alternatives.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Ustekinumab (UST) is becoming widely used as a therapeutic option for Crohn's disease (CD) as a biologic agent with a novel mechanism of interleukin (IL)-12/23 inhibition, which is expected to have therapeutic effects on pathology involving factors other than tumor necrosis factor (TNF)-α. In this study, we investigated the effect of UST on skin lesions and the rate of subsequent continuous maintenance treatment of CD with skin lesions that appeared as a paradoxical reaction to TNF-α inhibitor (TNFi).

Aims & Methods

Fifty-four patients with CD who were introduced UST as 2nd or 3rd Bio at our hospital from June 2017 to September 2020 were retrospectively enrolled in the study. We defined treatment discontinuation as hospitalization, surgery, or treatment change due to CD exacerbation. The cumulative continuous maintenance dose rate was calculated by the Kaplan-Meier method.

Results

Of the 54 patients, 10 had skin lesions as a paradoxical reaction to the previous TNFi. Eight patients were males, and 2 were females. The median (interquartile range) values for each were: age, 35.4 (32.9–39.2) year-old; disease duration, 13.4 (6.4–18.1) years; Harvey-Bradshaw Index (HBI), 3 (1–5.5); CRP, 0.22 (0.04–0.38) mg/dL, Alb 3.95 (3.6–4.4) g/dL. Infliximab in 4 patients and adalimumab in 6 patients were used as the last TNFi. Of the 10 patients in the group with the paradoxical reaction, 4 (50%; 2 psoriasiform eruptions, 2 folliculitis, and 1 palmoplantar pustulosis) achieved complete response of skin lesions, 5 (50%; 2 psoriasiform eruptions and 2 exacerbations of atopic dermatitis) achieved partial response. After 1 year of UST induction, the cumulative continuous treatment rate was 56.3% in the group with no paradoxical reaction and 70% in the group with paradoxical reaction, and there was no statistical difference between the two groups (Log-rank; P = 0.349). A univariate Cox regression analysis also showed that the clinical history of skin paradoxical response was not associated with UST sustained efficacy (Table).

Risk factors	Reference	HR(95%CI)	P value
Gender, Female	Male	0.97 (0.39-2.42)	0.95
Disease duration（yr）		0.99 (0.95-1.03)	0.53
Disease behavior, B2	B1	0.23 (0.07-0.73)	0.013
Disease behavior, B3	B1	0.14 (0.04-0.50)	0.0025
Perianal disease, Yes	No	0.51 (0.24-1.09)	0.082
Harvey–Bradshaw index at induction		1.05 (0.97-1.13)	0.27
Bio exposure, Double	Single	1.29 (0.6-2.76)	0.51
Concomitant IM, Yes	No	1.36 (0.62-2.98)	0.44
Skin paradoxical reaction, Yes	No	0.60 (0.21-1.76)	0.35

Conclusion

UST was highly effective in treating skin lesions as a paradoxical reaction to TNFi (90% partial or complete response). The cumulative continuous treatment rate after induction of UST was comparable to that of the group without paradoxical skin reaction, indicating that UST is useful for treating CD with paradoxical skin reaction to TNFi.