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Review
. 2022 Jul 20;11(14):4202.
doi: 10.3390/jcm11144202.

Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn's Disease: Systematic Review and Meta-Analysis of Observational Studies

Cristina Rubín de Célix  1 , María Chaparro  1 , Javier P Gisbert  1
Affiliations
Review

Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn's Disease: Systematic Review and Meta-Analysis of Observational Studies

Cristina Rubín de Célix et al. J Clin Med. .

Abstract

(1) Background: Evidence on the outcomes of ustekinumab treatment in real-world Crohn's disease (CD) patients is needed. Our aim was to evaluate the effectiveness and safety of ustekinumab in CD, reported by observational studies. (2) Methods: bibliographical searches were performed (PubMed, EMBASE).

Selection: observational studies assessing the effectiveness and safety of ustekinumab in CD.

Exclusion criteria: studies using ustekinumab as a prophylaxis for postoperative recurrence or perianal disease.

Data synthesis: effectiveness by intention-to-treat (random-effects model). Data were stratified by study design, population included, administered dose, and prior biologic exposure. (3) Results: A total of 63 studies (8529 patients) were included. Response was achieved in 60% (95% CI, 54-67%) in the short term (8-14 weeks); 64% (57-71%) in the medium term (16-24 weeks); and 64% (52-74%) in the long term (48-52 weeks). Remission was achieved in 37% (28-46%) in the short term; 42% (36-49%) in the medium term; and 45% (37-53%) in the long term. The endoscopic remission rate was 33% (25-40%) in the long term. Eighteen percent of patients lost response during follow-up. Nearly one-third of the patients needed dose optimisation, and in 59% of them it was effective. Twenty-five percent of patients developed adverse events, leading to treatment withdrawal in seven percent of the cases. (4) Conclusions: Ustekinumab is an effective and safe therapy in real-world refractory CD patients. Dose optimisation is frequently required, being effective in a high percentage of cases.

Keywords: Crohn’s disease; effectiveness; real-world evidence; safety; ustekinumab.

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Conflict of interest statement

Rubín de Célix has received education funding from Norgine, Janssen, Abbvie, Pfizer, Takeda, and Ferring. Chaparro MC has served as a speaker, consultant, and advisory member for, or received research funding from, AbbVie, Celltrion, Chiesi, Faes Farma, Falk Pharma, Ferring Pharmaceuticals, Gebro Pharma, Janssen, MSD, Otsuka Pharmaceuticals, Pfizer Inc, Roche, Shire Pharmaceuticals, Takeda, and Tillotts Pharma. Gisbert has served as a speaker, consultant, and advisory member for, or has received research funding from, MSD, Abbvie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos, Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine, and Vifor Pharma.

Figures

Figure 1
Figure 1
PRISMA flowchart of the screening and selection of relevant studies for inclusion in the meta-analysis.
Figure 2
Figure 2
Clinical response to ustekinumab in Crohn’s disease: (a) clinical response in the short term (8 w–14 w); (b) clinical response in the medium term (16 w–24 w); (c) clinical response in long term (48 w–52 w).
Figure 2
Figure 2
Clinical response to ustekinumab in Crohn’s disease: (a) clinical response in the short term (8 w–14 w); (b) clinical response in the medium term (16 w–24 w); (c) clinical response in long term (48 w–52 w).
Figure 3
Figure 3
Clinical remission associated with ustekinumab in Crohn’s disease: (a) clinical remission in the short term (8 w–14 w); (b) clinical remission in the medium term (16 w–24 w); (c) clinical remission in the long term (48 w–52 w).
Figure 3
Figure 3
Clinical remission associated with ustekinumab in Crohn’s disease: (a) clinical remission in the short term (8 w–14 w); (b) clinical remission in the medium term (16 w–24 w); (c) clinical remission in the long term (48 w–52 w).
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