Risankizumab in Oncologic Patients With Psoriasis: A Case Series

Abstract

The use of biologics in psoriatic patients with a history of malignancy is still a grey zone in the clinical practice. Guidelines recommend that these drugs should be avoided in subjects with a current or recently diagnosed malignancy, unless it has been treated more than 5 years earlier [1]. However, biologics may also be considered in patients with severe psoriasis and a recent diagnosis of malignancy (i.e., within 5 years) in a multidisciplinary joint decision with the oncologists. Still, due to the scanty literature on this topic, many clinicians prefer avoiding the use of biologics in oncologic patients, afraid of a possible relapse of the neoplasm. This concern is higher in patients who are candidate to interleukin (IL)-23 inhibitors (IL-23i), because there are no data regarding their use in oncologic patients.

We conducted a multicentric observational study of the use of risankizumab, a recently introduced IL-23i, in psoriatic and oncologic patients, with recent (i.e., < 5 years) or past (i.e., ≥ 5 years) diagnosis of malignancy, who attended the Outpatient Psoriasis of 8 referral centres in Tuscany, Italy. We collected a total of 11 patients (mean age 64.72 ± 9 years) (Table 1), of which five started the biologic before 5 years from the diagnosis of malignancy. In this latter group, two patients were diagnosed with breast cancer, one with prostatic adenocarcinoma, one with melanoma, and one with colorectal adenocarcinoma. One of the patients with breast cancer had also had a lung adenocarcinoma 9 years before. The mean time between the diagnosis of malignancy and the start of risankizumab was 33.6 ± 13.10 months. None of the patients experienced a relapse after a mean follow-up time of 14.4 ± 9.7 months (range 4–28 months). Six patients were treated with risankizumab after a diagnosis of malignancy was made a mean of 98.33 ± 62.23 months before. All patients were followed up for a mean of 11.16 ± 8.23 months without experiencing relapses. Ten patients out of 11 had been also treated with both systemic and biologic agents, before starting risankizumab. The mean PASI before therapy was 13.78, and all patients except one reached the PASI75 after 36 weeks of therapy. One patient withdrew the therapy after 9 months because of inefficacy.

Risankizumab is an IgG1 monoclonal antibody that binds to IL-23A with high affinity. It has shown an optimal safety profile during clinical trials, but in these trials patients with malignancy within 5 years were excluded [2].

Data about the progression of preexistent malignancies during therapy with risankizumab are scarce. Rusinol et al. [3] reported one patient treated with risankizumab with history of prostate cancer occurred 5 years earlier, who did not show disease progression. Another patient treated with risankizumab after only 2 months from a duodenal cancer diagnosis and followed for 96 weeks without experiencing relapses, was described by Valenti et al. [4]. Moreover, there are recent reports about the treatment of patients with risankizumab for anti-PD1/PD-L1 induced severe psoriasis, without side effects or recurrences [5, 6]. Our results are in line with such findings, demonstrating no risk of malignancy progression both in subjects who started risankizumab after a recent diagnosis of malignancy and in those who started the drug after 5 years.

IL-23 plays a pivotal role in stimulating the production of IL-17, which has both tumour-promoting effects and tumour-protective effects [7, 8]. Although the role of the IL-17/23 axis in cancer remains controversial, the aforementioned cases and our series suggest the safety of IL-23i in patients with a history of malignancies.

While our study is limited by the small population, this is still the largest case series about oncologic patients treated with risankizumab for psoriasis, including those with recent history of cancer.

Our report suggests that IL-23i may represent an optimal choice in psoriatic patients with previous malignancies because of its good safety profile and high efficacy. However, the paucity of data and the heterogeneity of cancers do not allow us to draw definitive conclusions. Therefore, national and international registries are now needed to develop large population studies and finally achieve definitive recommendations on this topic.

The authors confirm contributions to the paper as follows: Study conception and design: Michela Magnano and Emanuele Trovato. Data collection: Susanna Rossari and Michela Magnano. Analysis and interpretation of results: Eugenio Capalbo, Martina Dragotto, A. Di Cesare, Elia Rosi, Flavia Manzo Margiotta, Alessandra Michelucci, Salvatore Panduri, Federica Ricceri, Gionata Buggiani, L. Pescitelli, Elisa Lorenzoni, Barbara Simoni, Imma Savarese, Nicola Milanesi, Marco Romanelli, Pietro Rubegni, and Francesca Prignano. Draft manuscript preparation: Michela Magnano and Emanuele Trovato. All authors reviewed the results and approved the final version of the manuscript.

All patients in this manuscript have given written informed consent for participation in the study and the use of their deidentified, anonymized, aggregated data and their case details (including photographs) for publication. Ethical Approval: not applicable.

The authors declare no conflicts of interest.