Mycobacterium tuberculosis infection in psoriatic patients treated with biologics: Real‐world data from 18 Japanese facilities

Abstract

Although rare, tuberculosis has been reported with biologic treatment against psoriasis in Japan, a tuberculosis medium-burden country. Mycobacterial infection often develops after a long incubation period and might not have been adequately identified in clinical trials or post-marketing surveillance. To determine the real-world incidence of tuberculosis in psoriatic patients treated with biologics, we conducted a retrospective, multicenter, observational study in 18 facilities in Western Japan. Psoriatic patients who visited a participating facility between 2010 and March 2017 and received biologic reagents were enrolled. Information on sex, age at first biologic treatment, results of interferon-c release assay (IGRA) for Mycobacterium tuberculosis, treatment history with isoniazid, and onset of active and/or latent tuberculosis was collected. A total of 1117 patients (830 men and 287 women) were enrolled. The mean duration of biologic treatment was 3.54 years. Sixty-five patients (5.8%) showed positive IGRA results at screening. Active tuberculosis developed in two patients after the administration of tumor necrosis factor inhibitors (both involved miliary tuberculosis). Latent tuberculosis was observed in two patients treated with anti-interleukin-12/23p40 antibody. The incidence rate of tuberculosis, including latent tuberculosis, in this survey was 0.36%. Although the incidence rate of tuberculosis was low considering the observation period of biologic treatment, active tuberculosis was found in both the screening-negative group and a screening-positive subject after isoniazid prophylaxis (both miliary tuberculosis), concluding that negative screening or isoniazid treatment does not always assure that an individual has no tuberculosis. Hence, dermatologists still need to pay careful attention to tuberculosis at every patient visit.

Establishment of the Western Japan Psoriasis Registry and first cross‐sectional analysis of registered patients

“…This enables physicians to positively participate in the study and deepen their knowledge and skills. We have already published studies on tuberculosis 24 and PsA. 25 Our first cross-sectional data analysis revealed novel facts as well as confirming previously known facts.…”

“…In 2019, we established a non-profit organization called the Western Japan Inflammatory Skin Disease Research Group, and have performed retrospective surveys and published crosssectional analyses of tuberculosis 24 and PsA. 25 To observe patients longitudinally and answer important clinical questions about efficacy and safety, we established the WJPR as a multicenter observational prospective cohort.…”

The Tuberculosis Positive Conversion Rate Among Psoriasis Patients Treated with Adalimumab and Secukinumab: A Single-Center Retrospective Study in China

“…Parallel with previous real-world experience, we confirm the safety of SEC regarding TB activation among psoriasis patients [ 4 , 13 ]. In comparison, we recommend TB reevaluation in the first 3 months for patients treated with ADA in regions with high TB burden.…”

“…In Japan, a country with median TB burden, Sakae Kaneko et al. reported two LTBI cases (under treatment with TNFi and IL12/23i) and one active TB case (under treatment with TNFi for 5 months) among 1052 TB baseline-negative psoriasis patients [ 13 ]. In comparison, we reported a relatively high QFT conversion rate in the ADA group (5.43%) and SEC group (5.25%), and two active TB cases in the ADA group, indicating the importance of TB monitoring in high-burden areas.…”

Skin Mycobiome of Psoriasis Patients is Retained during Treatment with TNF and IL-17 Inhibitors

“…Although the causes of psoriasis are unclear, mouse models and biological treatment of humans show that underlying immunological mechanisms are dependent on the tumor necrosis factor (TNF)/interleukin (IL)-23/IL-17 axis [2]. When using biological treatments for psoriasis patients, clinicians should be aware of bacterial, fungal, and viral infections [3][4][5]. Anti-TNF-α antibodies are first-generation biologics that have a strong therapeutic effect on psoriasis and psoriatic arthritis; however, patients sometimes discontinue therapy due to infectious disease.…”