As noted in previous blog posts (see below), adult guidelines for ulcerative colitis favor ustekinumab over vedolizumab for ulcerative colitis patients who have had anti-TNF therapy; recent pediatric guidelines appeared to do the opposite, possibly due to limited data with ustekinumab.
A recent study (J Dhaliwal et al. AP&T 2021; https://doi.org/10.1111/apt.16388. One‐year outcomes with ustekinumab therapy in infliximab‐refractory paediatric ulcerative colitis: a multicentre prospective study) provides prospective data on ustekinumab effectiveness when given to children with UC refractory to other biologics; n=25. Thanks to Ben Gold for this reference.
- All patients had failed prior infliximab therapy, and 12 (48%) also had failed vedolizumab. Five patients discontinued ustekinumab after IV induction (four undergoing colectomy).
- On intent to treat basis, 44% (n=11) achieved the primary endpoint of steroid‐free remission at week 52, including nine (69%) of 13 who previously treated with anti‐TNF only vs two (17%) of 12 who previously failed also by vedolizumab. Seven of 11 remitters met the criteria for endoscopic improvement.
- Higher trough levels were not associated with a superior rate of clinical remission; the median (IQR) trough levels (μg/mL) were greater with q4 vs q8 weekly dosing (8.7 [4.6‐9.9] vs 3.8 [12.7‐4.8]) P = 0.02.
- No adverse events were associated with therapy.
My take: Ustekinumab is a good option for pediatric patients with ulcerative colitis who are refractory to anti-TNF agents. More data are needed to help in positioning therapies.
- AGA Guidelines: Moderate to Severe Ulcerative Colitis
- “Positioning Biologic Therapies in the Management of Pediatric Inflammatory Bowel Disease” & 14% of U.S. Infected with COVID-19 | gutsandgrowth
- Ustekinumab Over Vedolizumab as 2nd Line Agent for Crohn’s Disease | gutsandgrowth
- Comparative Efficacy: Vedolizumab vs Anti-TNF Agents | gutsandgrowth
Also, Humira (adalimumab) is now FDA-approved for children as young as 5 years with ulcerative colitis: FDA Approves Adalimumab as Treatment for Children With Ulcerative Colitis (2/25/21). “This approval is based on results from the phase 3, randomized, double-blind, multicenter ENVISION I (NCT02065557) study.” Abbvie has now updated their Humira dosing recommendations (Reference: https://www.rxabbvie.com/pdf/humira.pdf). Thanks to Clair Talmadge for this update.
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Is there any movement towards including checking drug levels (and antibodies) as part of the dosing strategy? Like adding it to the FDA guidelines so insurance would need to accept routine drug levels as part of treatment?
Not sure when proactive monitoring will be widely accepted by payers for biologics like ustekinumab and vedolizumab. Even for anti-TNF agents, it is not uncommon to receive denials from insurance despite very good studies supporting their use
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