Therapeutic Drug Monitoring in Perianal Fistulizing Crohn’s Disease
Abstract
:1. Introduction
2. Evidence behind the Current Biologic Therapies Utilized in the Management of Perianal Fistulizing Crohn’s Disease
3. Therapeutic Drug Monitoring: Current Application in Inflammatory Bowel Disease
4. Anti-Tumor Necrosis Factor Drug Levels and Outcomes in Perianal Fistulizing Crohn’s Disease
5. Discussion
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Author (Year) | Population | No. of Subjects | Anti-TNF | Primary Outcome | Drug Concentration in Active Fistulas (μg/mL) | Drug Concentration in Healed/Closed Fistulas (μg/mL) | Strengths | Limitations |
---|---|---|---|---|---|---|---|---|
Davidov et al. [35] (2016) | Adults | 36 | IFX | Decrease in drainage of fistulas | Week 2: 5.6 µg/mL Week 6: 2.55 µg/mL Week 14: 0.14 µg/mL | Week 2: 20.0 µg/mL Week 6: 13.3 µg/mL Week 14: 4.1 µg/mL | Similar demographics in both groups | small sample size, no imaging, subjective outcome |
Yarur et al. [36] (2016) | Adults | 117 | IFX | absence of drainage | 4.4 μg/mL | 15.8 μg/mL | Large sample size | Retrospective, didn’t distinguish simple vs. complex fistulas |
Strik et al. [37] (2019) | Adults | 47 IFX 19 ADA | IFX ADA | absence of discharge upon gentle finger and/or fistula closure on MRI | IFX: 2.3 μg/mL ADA: 4.8 μg/mL | IFX: 6.0 μg/mL ADA:7.4 μg/mL | Assessment with imaging | Retrospective, didn’t distinguish simple vs. complex fistulas |
Plevris et al. [38] (2020) | Adults | 29 IFX 35 ADA | IFX ADA | Absence of drainage | IFX:3.2 μg/mL ADA: 2.7 μg/mL | IFX: 8.1 μg/mL ADA: 12.6 μg/mL | Secondary outcome of fistula closure | Retrospective, no imaging |
Et Matary et al. [39] (2019) | Pediatric | 27 | IFX | Decrease in drainage of fistulas | 5.4 ug/mL | 12.7 ug/mL | Prospective study | Small sample size |
Ruemmele et al. [40] (2018) | Pediatric | 36 | ADA | Closure of baseline fistulas or decrease in number by ≥50% | Week 16: 7.0 ug/mL Week 52: 6.1 ug/mL | Week 16: 7.4 ug/mL Week 52: 10.0 ug/mL | Well defined endpoints | Not powered to detect statistical difference, not randomized, not placebo controlled |
Papamichael et al. [41] (2021) | Adults | Induction group n = 282 maintenance group n = 139 | IFX | Fistula response: reduction of at least 50% of draining fistulas from baseline | No Response: 4.0 μg/mL | Response: 5.7 μg/mL | large sample size, the use of stringent endpoints | No imaging assessment of fistula, not randomized |
De Gregario et al. [42] (2021) | Adults | 117 IFX 76 ADA | IFX | Radiologic healing (inflammatory subscore ≤6 on Van Assche Index) | IFX: 3.9 μg/mL ADA: 6.2 μg/mL | IFX: 6.0 μg/mL ADA: 9.1 μg/mL | Use of radiographic parameters | Not placebo controlled, not randomized |
Schwartz, D. A et al. [10] (2021) | Adults | VDZ (16) VDZ +10 (18) | VDZ | ≥50% decrease from baseline in the number of draining perianal fistulae at week 30 | ~33 μg/mL (pooled trough conc. week 10) | ~28 μg/mL (pooled trough conc. week 10) | Multicenter- RCT, use of MRI | Small sample size, no placebo arm |
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Zulqarnain, M.; Deepak, P.; Yarur, A.J. Therapeutic Drug Monitoring in Perianal Fistulizing Crohn’s Disease. J. Clin. Med. 2022, 11, 1813. https://doi.org/10.3390/jcm11071813
Zulqarnain M, Deepak P, Yarur AJ. Therapeutic Drug Monitoring in Perianal Fistulizing Crohn’s Disease. Journal of Clinical Medicine. 2022; 11(7):1813. https://doi.org/10.3390/jcm11071813
Chicago/Turabian StyleZulqarnain, Mir, Parakkal Deepak, and Andres J. Yarur. 2022. "Therapeutic Drug Monitoring in Perianal Fistulizing Crohn’s Disease" Journal of Clinical Medicine 11, no. 7: 1813. https://doi.org/10.3390/jcm11071813