PMID- 37556515
OWN - NLM
STAT- MEDLINE
DCOM- 20230811
LR  - 20230815
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 22
IP  - 8
DP  - 2023 Aug 1
TI  - Real-World Effectiveness and Safety of Tildrakizumab in Patients With 
      Moderate-to-Severe Psoriasis: Week 28 Interim Analysis of a Phase 4 Study.
PG  - 754-760
LID - 10.36849/jdd.7471 [doi]
AB  - BACKGROUND: Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody 
      approved for the treatment of adults with moderate-to-severe plaque psoriasis. 
      This analysis evaluated real-world effectiveness and safety of tildrakizumab for 
      28 weeks. METHODS: In this Phase 4 study (NCT03718299), adults with 
      moderate-to-severe plaque psoriasis received tildrakizumab 100 mg subcutaneously 
      at week 0, week 4, and every 12 weeks thereafter. Clinical improvement was 
      assessed from Psoriasis Area and Severity Index (PASI) score change from 
      baseline; disease activity from body surface area (BSA) percentage affected, 
      static Physician's Global Assessment (sPGA), and sPGA x BSA; and safety from 
      adverse events (AEs). RESULTS: At week 28, 52/55 enrolled patients were assessed. 
      Mean (standard deviation [SD]) PASI score decreased significantly (P<0.001) from 
      11.6 (7.1) at baseline to 1.8 (3.0; 82.1% improvement) at week 28; 55.8% of 
      patients achieved PASI 90 response. From baseline to week 28, mean (SD) BSA 
      decreased significantly from 14.5% (11.5%) to 2.9% (6.4%), sPGA from 3.2 (0.6) to 
      1.2 (0.9), and BSA x sPGA from 47.0 (41.5) to 6.8 (20.3; all P<0.001). Serious 
      AEs were infrequent. No treatment-emergent AEs were considered related to 
      tildrakizumab. Conclusions: Real-world tildrakizumab treatment significantly 
      improved clinical status and reduced disease activity, with no new safety 
      concerns. Heim J, Gabriel Vasquez J, Schenkel B, et al. Real-world effectiveness 
      and safety of tildrakizumab in patients with moderate- to-severe psoriasis: week 
      28 interim analysis of a phase 4 study. J Drugs Dermatol. 2023;22(8):754-760. 
      doi:10.36849/JDD.7471.
FAU - Heim, Jayme
AU  - Heim J
FAU - Vasquez, J Gabriel
AU  - Vasquez JG
FAU - Schenkel, Brad
AU  - Schenkel B
FAU - Bhatia, Neal
AU  - Bhatia N
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - DEW6X41BEK (tildrakizumab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Treatment Outcome
MH  - Double-Blind Method
MH  - *Antibodies, Monoclonal, Humanized/adverse effects
MH  - *Psoriasis/diagnosis/drug therapy/chemically induced
MH  - Severity of Illness Index
EDAT- 2023/08/09 18:42
MHDA- 2023/08/11 06:43
CRDT- 2023/08/09 13:54
PHST- 2023/08/11 06:43 [medline]
PHST- 2023/08/09 18:42 [pubmed]
PHST- 2023/08/09 13:54 [entrez]
AID - S1545961623P0754X [pii]
AID - 10.36849/jdd.7471 [doi]
PST - ppublish
SO  - J Drugs Dermatol. 2023 Aug 1;22(8):754-760. doi: 10.36849/jdd.7471.