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. 2024 Jun 14:17:1413-1422.
doi: 10.2147/CCID.S454971. eCollection 2024.

Reactivation Risk of Latent Tuberculosis or Inactive Hepatitis B Virus Infection and Effectiveness of Ustekinumab in Chinese Plaque Psoriasis Patients: A 28-Week Retrospective, Observational Study

Wensheng Lu  1 , JianFeng Wang  2 , YuanJing Zhang  1 , Ruixue Chang  1 , Jun Zhao  3
Affiliations

Reactivation Risk of Latent Tuberculosis or Inactive Hepatitis B Virus Infection and Effectiveness of Ustekinumab in Chinese Plaque Psoriasis Patients: A 28-Week Retrospective, Observational Study

Wensheng Lu et al. Clin Cosmet Investig Dermatol. .

Abstract

Introduction: This study observed the effectiveness of ustekinumab and reactivation risk of concurrent latent tuberculosis infection (LTBI) and inactive hepatitis B virus (HBV) infection in Chinese mainland psoriasis patients on ustekinumab treatment.

Methods: This retrospective, multicenter, observational study was conducted in three centers in China. Adult patients with moderate to severe plaque psoriasis were treated with ustekinumab for 28 weeks. The effectiveness endpoint included 75% and 90% improvement in Psoriasis Area Severity Index (PASI75/90) response rate, percentage of PASI improvement, change of absolute PASI score and body surface area involvement (BSA) score, absolute PASI ≤1/3 and Physicians' Global Assessment (PGA)=0/1, as well as Dermatology life quality index (DLQI)=0/1 response rate at week 4, 16 and 28. Screening of tuberculosis and hepatitis were performed at baseline and week 28.

Results: A total of 82 patients were enrolled between March 2021 and May 2023 and the number of patients combined with LTBI and inactive HBV infection was 20 and 21 respectively. The PASI75 and PASI90 response rate at week 28 was 95.1% and 81.7% respectively. The mean PASI score decreased from 14.93 ± 12.07 at baseline to 0.78 ± 1.86 at week 28, and the mean BSA score decreased from 21% ± 18% at baseline to 1% ± 2% at week 28 (both P<0.001 compared with baseline). DLQI 0/1 response rate at week 28 was 73.2%. No reactivation of LTBI and inactive HBV infection and also no new-onset tuberculosis and hepatitis B occurred in patients without LTBI and inactive HBV infection at baseline.

Conclusion: Ustekinumab demonstrated great effectiveness in Chinese plaque psoriasis patients and good safety in psoriasis concurrent with LTBI and inactive HBV infection under the real-world setting.

Keywords: LTBI; inactive HBV infection; plaque psoriasis; real-world effectiveness; ustekinumab.

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Conflict of interest statement

The authors have no potential conflicts of interest or financial disclosures that are pertinent to this article.

Figures

Figure 1
Figure 1
PASI 75 and PASI 90 response rate (A) and percentage of PASI improvement (B) during the 28-week treatment period.
Figure 2
Figure 2
Change of absolute PASI score (A) and BSA score (B) during the 28-week treatment period. *P<0.001 compared with baseline; #P<0.001 compared with week 4; ‡P<0.001 compared with week 16; §P=0.001 compared with week 16.
Figure 3
Figure 3
Percentage of patients achieved aPASI≤1, aPASI≤3 and PGA=0 during the 28-week treatment period.
Figure 4
Figure 4
(A) Change of DLQI score and (B) percentage of patients achieved DLQI 0/1 during the 28-week treatment period.
See this image and copyright information in PMC

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