Tag Archives: Crohn’s disease

How to Improve the Value of Biologic Infusions: Reduce Lab Testing and Frequency

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T Shah et al. JPGN Reports 2026;1–5. Responsible laboratory surveillance of pediatric patients with inflammatory bowel disease on biologic infusion therapy

This retrospective single-center study with 34 pediatric patients with inflammatory bowel disease examined the laboratory costs (2020-2021) associated with monitoring biologic therapy.

Methods: “Routine laboratory studies were defined as those part of the standardized infusion protocol at SBCH and were obtained with each scheduled infusion. The following laboratory studies were considered routine/standard: complete blood count with differential, basic metabolic panel, liver function tests, amylase, lipase, erythrocyte sedimentation rate, C-reactive protein, vitamin D, iron, ferritin, vitamin B12, folate, urine hCG (if a subject was female). Other laboratory studies that were collected, but not considered routine studies included QuantiFERON-TB, and biologic drug and antibody level.”

Key findings:

  • The average hospital charge for studies obtained per infusion was $1308.36 with an average annual cost of $9543.44 per patient
  • Fifteen (6%) instances of change in clinical management were found. “Only a limited subset of the 15 laboratory studies included were utilized in making changes: biologic drug, Vitamin D, and iron level”
  • During the study, 248 infusions were administered with a “total annual charge amongst all patients in the study was $324,447”

Discussion:

  • “Our study population had well controlled disease as evident by low PCDAI and PUCAI scores…Our observations suggest the utility of routine laboratory surveillance at each biologic infusion is minimal, favoring decreased testing for IBD patients, especially those in clinical remission.”
  • “We propose obtaining laboratory tests twice a year, or with every third infusion, for patients with mild disease or in remission based on their disease activity index scores. In our small cohort of patients, this change in practice would reduce the total annual costs by 66% ($214,154.82)”

My take: It has been my practice, for most patients with IBD, to obtain labs with every other infusion (~3 times per year). Typically, I will obtain a CBC/d, CMP and CRP and obtain other labs like Vit D, GGT, Quantiferon Gold and drug level monitoring less frequently. I rarely check Vit B12, ESR, Folate, Amylase, and Lipase.

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Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician. Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure. This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

VedoKids Study: Vedolizumab for Extraintestinal Manifestations of Inflammatory Bowel Disease

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G D’Arcangelo et al. J Pediatr Gastroenterol Nutr. 2026;82:495–502. Open Access! Vedolizumab for extraintestinal manifestations in pediatric inflammatory bowel disease: Results from the VedoKids study

Background: “Since vedolizumab is a gut-selective anti-α4β7 integrin, its effect on EIMs has been a matter of debate, with relevant data lacking in pediatric IBD. A systematic review, which included three interventional studies, five non-interventional studies, and three case series, concluded that there is insufficient evidence supporting the efficacy of vedolizumab for treating pre-existing EIMs in adults.3“

Methods: This was a subgroup analysis of the pediatric VedoKids cohort, a multicenter, prospective “real-life” study of children (aged 0–18 years) with IBD treated with vedolizumab and followed through 54 weeks.

Key findings:

  • EIMs were identified in 18/142 (12.6%) children at baseline
  • Children with EIMs had an average age of diagnosis of 9 yrs compared to 12 yrs in those without EIMs
  • Children with EIMs had higher rate of pancolitis in UC and ileocolonic distribution in CD
  • Prior anti-TNF medication was noted in 16 (89%) of EIM cohort compared to 74 (60%) of non-EIM cohort
  • Concomitant medications were administered in 72% of EIM cases and to a similar number of non-EIM patients. For EIM patients, ASA were given in 7, steroids in 10, thiopurines in 4 and methotrexate in 2
  • Children with EIMs had more active disease (see below)
  • EIM resolution rate of 89%, mainly occurring within the early weeks of vedolizumab treatment

My take: While this study has several limitations, including the high rate of concomitant medications, it shows that most patients receiving vedolizumab had resolution of their EIMs. In addition, it shows that patients with EIMs had a more severe IBD phenotype.

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Methotrexate Tolerance and Toxicity in Pediatric Inflammatory Bowel Disease

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E Vermeer et al. J Pediatr Gastroenterol Nutr. 2026;82:477–486. Open Access! Methotrexate toxicity and intolerance in paediatric inflammatory bowel disease: A retrospective cohort study

This was a  a retrospective single-center cohort study, including pediatric IBD patients (n=207) initiating MTX between 2010 and 2023. The median follow-up time was 303 days.

Key findings:

  • Methotrexate was used in combination with a biologic medication in 114 patients (55%)
  • 157 patients (75.8%) experienced at least one MTX-induced AE, with hepatotoxicity occurring in 84 patients (53.5%), myelotoxicity in 43 patients (27.4%), and nausea in 95 patients (60.5%). Most hepato- and myelotoxicity cases were categorized as grade 1 or mild (60.7% and 81.4%, respectively). 10 patients had grade 3 hepatotoxicity (ALT 195-780 U/L)
  • Nausea was reported in 46%. Fatigue was identified in 13, Headache in 6, and Alopecia in 6
  • MTX was discontinued in 60 out of 157 cases with an AE (38%), including 27 following nausea, 27 and 4 following hepatotoxicity
  • Sixty-five (43.0%) of all biochemical toxicities occurred within the first 3 months of MTX initiation
  • Strategies to manage AEs included reduced dosage, use of antiemetics or PPIs, and change in route of administration

Discussion:

  • The authors recommend biochemical testing after initiation “at 2, 4, 8, and 12 weeks, as most actionable toxicities occurred during this period. After 3 months, laboratory assessments could potentially be spaced out to every 4–6 months instead of every 3 months for stable patients, aligning with the new Dutch guideline for monitoring MTX toxicity in rheumatology.41 More frequent testing should be reserved for patients with risk factors such as renal dysfunction, hepatotoxic co-medications, or prior toxicity.42“
  • A study limitation was “the frequent use of combination therapy, leading to a heterogeneous study population and possible overestimation of AE rates”

My take: Methotrexate remains an important part of treatment, especially combination treatment to prevent or overcome immunogenicity. Careful monitoring and prophylactic treatments of nausea may improve durability.

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Japanese Garden, Buenos Aires

Longer Adalimumab Dosing Intervals Associated with Worse Outcomes for Crohn’s Patients in Remission (LADI Trial)

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LMA Van Lierop et al. Gastroenterol 2026; 170: 404-407. Open Access! Long-Term Outcomes of Increased Versus Conventional Adalimumab Dose Interval for Patients With Crohn’s Disease in Stable Remission: 3-Year Follow-Up of the Randomized Controlled LADI Trial

Methods: “The LADI trial enrolled adults with luminal CD in corticosteroid-free clinical (CFCR) and biochemical remission, on adalimumab, 40 mg every 2 weeks. After randomization in a 2:1 ratio, the intervention group started on a 3-week interval and increased to 4 weeks, if in clinical and biochemical remission at week 24. The control group remained on adalimumab biweekly…The primary end point in this long-term follow-up (LTFU) study was the proportion of patients in CFCR (Harvey Bradshaw Index [HBI] <5 or remission per Physician Global Assessment [PGA] without systemic corticosteroids) without complications at year 3, on the assigned adalimumab interval.”

Key findings:

  • The proportion of patients achieving the primary end point was 34 of 95 (35.8%, intervention) vs 41 of 48 (85.4%, control; P < 0.001).
  • At year 3, 39 of 95 (41.1%) in the intervention group remained on the randomized or further de-escalated adalimumab regimen
  • Kaplan-Meier analyses of secondary end points showed the following probabilities at year 3 (intervention vs control) (Figure 1): remaining on the assigned adalimumab dose, 41.4% vs 91.4% (P < .0001); remaining on adalimumab, 83.7% vs 95.8% (P = .026); corticosteroid-free survival, 87.4% vs 95.7% (P = .062); and complication-free survival, 83.2% vs 97.9% (P = .015)
Kaplan-Meier curves visualizing maintenance of assigned dosing at baseline, continued adalimumab therapy, and corticosteroid-free survival in both groups. (A) Probability of maintaining assigned adalimumab dosing interval of 3–4 weeks (intervention) vs 2 weeks (control).
(B) Probability of remaining on adalimumab therapy over time.
(C) Probability of remaining in corticosteroid-free remission.

My take: About 60% of patients were unable to de-escalate their adalimumab dosing interval. Suboptimal dosing increased the risk of complications and having adalimumab therapy become ineffective.

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PREdiCCt Trial: Lower Calprotectin Targets in Crohn’s Disease and Ulcerative Colitis

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Constantine-Cooke N, Gros B, Plevris N, et al Gut 2026. doi: 10.1136/gutjnl-2025-337846. (Open Access!) Associations between demographic, clinical and dietary factors and flares in inflammatory bowel disease: the PRognostic effect of Environmental factors in Crohn’s and Colitis (PREdiCCt) prospective cohort study

Methods: Multicentre, prospective cohort study conducted across 47 UK centres. Patients with Crohn’s disease (CD), ulcerative colitis (UC) or IBD unclassified (IBDU) in self-reported remission were prospectively followed up. 2629 participants (1370 CD; 1259 UC/IBDU) – followed up for a median of 4.1 years.

Key findings:

  • Baseline FC was strongly associated with patient-reported flares (FC ≥250 µg/g: adjusted HR (aHR) 2.22; FC 50–250 µg/g: aHR 1.52 (reference <50 µg/g)).
  • Baseline FC was also strongly associated with objective flares (FC ≥250 µg/g: aHR 3.25; FC 50–250 µg/g: aHR 1.98). Objective flares were “clinical flare plus C-reactive protein >5 mg/L and/or faecal calprotectin (FC) >250 µg/g with treatment escalation.” In ulcerative colitis, the probability of an objective flare within two years rose from 11% in those with baseline calprotectin below 50 µg/g to 34% in those above 250.
  • At 24 months, cumulative patient-reported and objective flare rates were 28% and 12% in CD, and 33% and 15% in UC/IBDU, respectively. Overall, patient-reported flares were more common (31%), while objective flares were less frequent (14%).
  • In UC, higher total meat intake was associated with increased risk of objective flares (highest versus lowest quartile: aHR 1.95, 95% CI 1.07 to 3.56). The absolute two-year risk rose from 12% in the lowest quartile of meat intake to 26% in the highest.
  • No consistent associations were observed for ultraprocessed foods, fiber or polyunsaturated fatty acids and flare.
Flares by faecal calprotectin (FC) stratified into FC < 50, 50 ≤ FC ≤ 250, and FC >250 μg/g. (A) Patient-reported flare in Crohn’s disease; (B) objective flare in Crohn’s disease; (C) patient-reported flare in ulcerative colitis/inflammatory bowel disease unclassified; (D) objective flare in ulcerative colitis/inflammatory bowel disease unclassified. aHR, adjusted hazard ratio.

My take: Lower calprotectin values, even in remission, are associated with better outcomes. Risk was meaningfully increased even in the 50–250 µg/g range, compared with levels below 50. Higher meat intake may increase the risk of flares for UC.

Summary of study information from Charlie Lees: The PREdiCCt Study: Can We Predict IBD Flares?

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Detecting Preclinical Crohn’s Disease in First-Degree Relatives with Biomarker Screening

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D Turner et al. . Gut 2025;0:1–7. doi:10.1136/gutjnl-2025-336368. Preclinical stages of Crohn’s disease defined by faecal calprotectin in asymptomatic first-degree relatives: screening framework for prevention trial

Methods: “Faecal calprotectin was measured in asymptomatic FDRs aged 6–38 years; those with persistent elevation, defined as >70 µg/g in at least two separate tests, were offered panenteric video capsule endoscopy or ileocolonoscopy”

Population: 331 (35%) first-degree relatives (FDRs) (from a group of 950) agreed to be screened: 63 (19%) had persistently elevated calprotectin, of whom 42 underwent further evaluation

Key findings:

  • From the initial screened cohort of 331 patients, nine (2.7%) had endoscopic appearance compatible with presymptomatic CD, and 22 (6.6%) had non-specific macroscopic mucosal changes
  • Median calprotectin was significantly higher in those with presymptomatic CD (772µg/g (IQR 279–1685)) compared with others (31µg/g (IQR 30–61), p<0.0001)
  • Calprotectin >225 µg/g predicted presymptomatic CD (area under the receiver operating
    characteristic curve 0.97 (95% CI 0.94 to 1.0; p<0.001; sensitivity 89%, specificity 94%)

Discussion Points:

  • “There is no universally accepted definition for preclinical stages of CD, and
    the distinction between these stages remains partly subjective.”
  • “The lack of longitudinal follow-up is also a limitation, but this will be completed as part of the PIONIR trial.”

My take (borrowed in part from the authors):

  1. Identification of pre-symptomatic CD “can facilitate designing targeted interventions and defining inclusion criteria for prevention trials.” The disease may be more modifiable in the early stages of disease.
  2. This trial suggests the calprotectin threshold of >70 is too low to target screening. For specificity, the study showed that persistent elevation above 225 merits investigation; though, it has been our practice to use a threshold of >150 for children older than 5 years.
  3. Approximately 5% of asymptomatic FDRs of CD patients have evidence of pre-symptomatic CD and approximately 10% more have non-specific mucosal changes when evaluated

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IBD Briefs: Upadcitinib in Children with Severe Colitis and Timing of Infliximab Switch to SC Route in Adults

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A Yerushalmy-Feler et al. Inflammatory Bowel Diseases, 2025, 31, 3320–3326. Real-World Experience with Upadacitinib for Pediatric Acute Severe Ulcerative Colitis: An International Multicenter Retrospective Study from the Pediatric IBD Porto Group of ESPGHAN

In this study of 22 pediatric patients with ASUC refractory to infliximab, key findings:

  • By week 26, 14 (64%) were in corticosteroid-free clinical remission and 16 (73%) patients remained colectomy-free
  • Two serious AEs of an appendiceal neuroendocrine tumor and cytomegalovirus colitis

My take: It is good to see more pediatric data. The availability of upadacitinib will likely lead to lower colectomy rates.

Related blog post: IBD Briefs: Upadacitinib in Children, Predicting Crohn’s Disease, and Autoimmune Diseases Associated with IBD

L Bertani et al. Inflammatory Bowel Diseases, 2025, 31, 3363–3369. When to Switch to Subcutaneous Infliximab? The RE-WATCH Multicenter Study

Methods: The RE-WATCH study was an observational, multicenter, retrospective study performed in four IBD referral centers. Inclusion criteria meant that only patients receiving on label SC-IFX at a dosage of 120 mg every other week were included in the study. The initiation of IFX therapy as the baseline timepoint.

Key findings:

  • There were no statistical differences between the two groups, early vs. late switch, after one year in terms of the respective endoscopic response (71.4% vs 70.8%, P = .95), steroid-free clinical remission (62.5% vs 68.7%, P = .51), or IFX retention rate (75.0% vs 66.7%, P = .35).
  • There was higher endoscopic remission rates in early switch patients as compared to late switch patients; however, this trend was not significant (69.6% vs 52.1%, P = .07).
  • A return to IV-IFX was required in 1 of 43 early switch patients and in 3 of 44 late switch patients (2.3% vs 6.8%, P = .31)
  • While the early switch group appears to fare a little better, there is likely a selection bias. For example, the early group had a much lower rate of severe endoscopic score at baseline (20% vs. 54%) and lower rate of Crohn’s fistulizing disease (8% vs 33%).
partial Mayo score (pMS)
Harvey–Bradshaw index (HBI)

My take: These results indicate that outcomes are similar between patients switching from to IFX SC at both early (after induction) and late (after 6 months).

It is worth noting that prior studies have shown that home-based therapies (eg. home infusion), compared to office-based therapies, have been “associated with suboptimal outcomes including higher rates of nonadherence and discontinuation of infliximab.” This is a concern for SC biologics as well.

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Effectiveness of Switch to Subcutaneous Infliximab

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N Mathieu et al. Clin Gastroenterol Hepatol 2025; 23: 2597 – 2606. Open Access! PErsistence and Safety of Subcutaneous Infliximab 1 Year After Switch From Intravenous Route in IBD Patients in REMission

Methods: The PEREM (PErsistence, effectiveness and safety of subcutaneous infliximab after switch from intravenous infliximab in IBD patients in REMission) study, a prospective national French cohort trial, enrolled 426 patients with IBD. Participants were in steroid-free clinical remission for at least 6 months on IV-IFX when they switched to SC-IFX. 56% were on IV-IFX standard dosing (5 mg/kg 8-weekly) and 16% received combination therapy with an immunomodulator drug at baseline. All patients were switched to SC-IFX standard dosing (ie, 120 mg every other week). The treatment could be intensified during follow-up, either to 120 mg every week or 240 mg every other week.

Key Findings:

  •  At week 48, SC-IFX persistence was 95.4%
  •  86.9% of patients were in steroid-free clinical remission
  • Mean infliximab levels were 8.0 μg/mL at inclusion and 18.0 μg/mL at week 48 (P < .0001)
  • Among the 19 (4.5%) patients who stopped SC-IFX, 6 (1.4%) switched back to IV-IFX
  • 23 (5.4%) patients required SC-IFX dose escalation
  • Dosing at 10 mg/kg/Q4W had 100% SC IFX persistence compared to 95% for 5 mg/kg/Q8W; however, at the 48 week followup, there were only 6 patients in the higher dose compared to 149 in the lower dose
  • Ongoing use of combination therapy was not associated with better persistence. Though, only 7 patients were receiving combination therapy at the 48 week followup

From the discussion:

  • “The high persistence observed in the PEREM study is partly explained by the long-term control of the disease by the time of switch, the median time since last flare being over 5 years before inclusion. Henceforth, the persistence observed here is in accordance with results on long term maintenance of IV-IFX, the yearly persistence of IV-IFX without intervention being 87%.”
  • SC-IFX was associated with higher levels. However, this was expected and higher levels are needed with SC administration. The “different bioavailability of SC-IFX compared with IV-IFX is responsible for different goals of infliximab blood levels depending on its route. In particular, a level above 20 μg/mL has been associated with higher rates of remission20” with SC-IFX.

My take: This study shows that SC-IFX is a good option for patients in long-term remission. With SC-IFX therapy, more effort is needed to make sure patients are adherent with therapy and monitoring in order to achieve optimal outcomes.

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Video Capsule Endoscopy in VEO-IBD — Is the Juice Worth the Squeeze?

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S-I Hagiwara et al.  Inflammatory Bowel Diseases, 2025; izaf144, https://doi.org/10.1093/ibd/izaf144. Open Access! Feasibility and Safety of Small Bowel Capsule Endoscopy in Very Early-Onset Inflammatory Bowel Disease: A Multi-Institutional Study

This article shows that video capsule endoscopy (VCE) (aka small bowel capsule endoscopy [SBCE]) is feasible in children with very early-onset inflammatory bowel disease (VEO-IBD). There were 82 patients (median age, 3.8 years; median body weight, 13.0 kg) who underwent 104 SBCEs. All capsules were deployed endoscopically. Gastrointestinal patency was assessed in 95% of procedures, most commonly using patency capsules (70%).

Key findings:

  • Observation of the entire small intestine was achieved in 100 (96.1%) patients
  • Of the remaining 4 patients, 3 could not undergo a complete observation of the entire small intestine due to battery depletion, and 1 had the capsule retained in the stomach
  • Abnormal small bowel findings were observed in 42% of patients, with aphthae being the most common (34%), followed by ulcers (18%)

In their discussion, the authors note that due to young age, the capsules and the patency capsules required endoscopic deployment (best in duodenum). Thus, most patients received general anesthesia or intravenous sedation twice within a short period.

The authors note that “SBCE has been reported to be superior to MRE in detecting superficial mucosal activity… [and] offers a radiation-free, relatively well-tolerated, and highly sensitive method for mucosal evaluation in VEO-IBD.”

My take: Given the typical use of a patency capsule and thus the need for two separate anesthesia dates, I doubt the “juice is worth the squeeze” in utilizing SBCE for most patients VEO-IBD.

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Useful repurposing of phone booth in Cotwolds, UK

Postoperative Outcomes with Tofacitinib Following Colectomy for ASUC and Real-World Outcomes for Upadacitinib in Crohn’s Disease

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C Larson et al. Clin Gastroenterol Hepatol 2025; 23: 2263-2271. Postoperative Outcomes in Tofacitinib-Treated Patients With Acute Severe Ulcerative Colitis Undergoing Colectomy

This  was a multicenter, retrospective, case-control study of patients hospitalized with ASUC who underwent colectomy, comparing patients treated with tofacitinib (n=41) prior to colectomy with infliximab-treated controls (n=68).

Key findings:

  • Compared with tofacitinib-treated patients, infliximab-treated patients had higher overall rates of overall (44 [64.7%] vs 13 [31.7%]; P = .002) and serious (19 [27.9%] vs 3 [12%]; P = .019) postoperative complications

My take: This study supports the safety of JAK inhibitor therapy for ASUC. It showed a significantly lower rate of overall postoperative complications in ASUC patients treated with tofacitinib compared with infliximab; the authors note that “these findings can likely be extrapolated to upadacitinib, a selective JAK inhibitor, given its similar mechanism of action.”

J Devi et al. Clin Gastroenterol Hepatol 2025; 23: 2281-2291. Open Access! Real-World Effectiveness and Safety of Upadacitinib in Crohn’s Disease: A Multicenter Study

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