Infliximab, vedolizumab similarly effective as 1L Tx for paediatric IBD

In a study presented at Crohn’s and Colitis Congress 2024, infliximab and vedolizumab were found to have similar effectiveness in achiev­ing steroid-free clinical remission (SFCR) and biochemical remission (BR) at 12 months when used as first-line treatment for biologic-naïve paediatric patients with un­complicated mild-to-moderately active inflammatory bowel disease (IBD).

The infliximab group had numerically lower SFCR and BR rates at 6 months compared with the vedolizumab group (63.89 percent vs 80.00 percent; p=0.17 [SFCR] and 53.13 percent vs 76.47 percent; p=0.08 [BR]).

By month 12, the rates were already similar between arms (72.06 percent vs 71.43 percent; p=0.96 [SFCR] and 59.62 percent vs 76.47 percent; p=0.21 [BR]).

There were no significant differences between the infliximab and vedolizumab groups in terms of clinical assessment scores such as Paediatric Ulcerative Colitis Activity Index (PUCAI) for ulcerative colitis (UC) patients (5 vs 4; p=0.52) and Paediatric Crohn’s Disease Activity Index (PCDAI) for participants with Crohn’s disease (CD; 3 vs 6; p=0.13). [CCC 2024, abstract 156]

Laboratory values for those who achieved SFCR at 12 months were not significantly different between the infliximab and vedolizumab arms. The parameters evaluated were faecal calprotectin (81.66 vs 56.31 µg/mg; p=0.16), albumin (4.17 vs 4.49 g/L; p=0.12), erythrocyte sedimentation rate (ESR; 12.3 vs 5.17 mm/hr; p=0.08), and haemoglobin (12.84 vs 13.69 g/dL; p=0.23).

“Infliximab is the only FDA-approved IV therapy for the treatment of paediatric IBD, [while] the gut-selective anti-integrin vedolizumab has been increasingly used as second-line therapy,” said the researchers. However, the comparative effectiveness of infliximab and vedolizumab for the treatment of IBD in biologic-naïve children is unclear.

To ascertain the real-world effectiveness and safety of both agents in a bio-naïve paediatric IBD setting at 12 months, the team conducted a single-centre retrospective cohort study at an academic children’s hospital between February 2015 and August 2023. They evaluated 100 patients (mean age 13 years) with mild-to-moderate disease who started infliximab (n=73) or vedolizumab (n=27) as their first advanced therapy.

More than two-thirds (68.49 percent) of infliximab recipients were boys; for the vedolizumab subgroup, the corresponding rate was 40.74 percent. Overall, 49 percent had CD, 48 percent had UC, and 3 percent had unclassified IBD. Infliximab- and vedolizumab-treated patients had similar Paris classifications for CD, UC, and unclassified IBD.

Compared with the vedolizumab group, the infliximab group had lower baseline albumin (3.7 vs 4.2 g/L; p<0.01) and faecal calprotectin levels (886 vs 1,307 µg/mg; p=0.07) and fewer participants who were on steroids at baseline (57.53 percent vs 74.07 percent; p=0.13).

Conversely, the infliximab arm had higher baseline PUCAI score (37 vs 28; p=0.12) and ESR level (21.00 vs 13.09 mm/hr; p=0.14) than the vedolizumab arm.

The primary outcome was SFCR at 12 months, which was defined as PUCAI <10 or short PCDAI <10 and being off corticosteroids. BR was defined as faecal calprotectin <250 μg/g.

The incidence of adverse events was low in both arms, with only six and two events in the respective infliximab and vedolizumab arms, corresponding to 8.22 percent and 7.41 percent (p=0.89). All events were rated as mild to moderate. These included infusion reaction, elevated liver enzymes, eczema, folliculitis, infection, and psoriasis.

The researchers called for larger prospective head-to-head studies to further validate the findings.