IBD Journal Scan
Key articles from high impact journals in last month
Editorial Recommendations
AUG-2025
SONIC - Infliximab plus Azathioprine in CD
A randomized, double-blind trial compared infliximab, azathioprine, and their combination in 508 adults with moderate-to-severe Crohn’s disease, treatment-naïve to immunosuppressives or biologics. At week 26, corticosteroid-free remission was achieved in 56.8% on combination therapy, versus 44.4% on infliximab (P=0.02) and 30.0% on azathioprine (P<0.001 vs combination; P=0.006 vs infliximab). Mucosal healing occurred in 43.9% with combination therapy, 30.1% with infliximab (P=0.06), and 16.5% with azathioprine (P<0.001 vs combination; P=0.02 vs infliximab). Trends persisted through week 50. Serious infections occurred in 3.9% (combination), 4.9% (infliximab), and 5.6% (azathioprine). Combination therapy was more effective than either monotherapy, without increased serious infection risk.
UC SUCCESS - Infliximab plus Azathioprine in UC
In a randomized, double-blind trial, 239 tumor necrosis factor-α antagonist–naïve adults with moderate-to-severe ulcerative colitis received 16 weeks of infliximab monotherapy, azathioprine monotherapy, or combination therapy. Infliximab (5 mg/kg) was administered intravenously at weeks 0, 2, 6, and 14; azathioprine (2.5 mg/kg) was given orally daily. Corticosteroid-free clinical remission at week 16 was achieved by 39.7% on combination therapy, versus 22.1% on infliximab (P=0.017) and 23.7% on azathioprine (P=0.032). Mucosal healing occurred in 62.8% with combination therapy, 54.6% with infliximab (P=0.295), and 36.8% with azathioprine (P=0.001). Serious infections were rare (1 each in infliximab and azathioprine groups). Combination therapy showed superior efficacy over either monotherapy without increased serious infection risk.
COMMIT - Infliximab plus Methotrexate in CD
In a 50-week, double-blind, placebo-controlled trial, 126 Crohn’s disease patients recently started on prednisone induction were randomized to receive infliximab plus methotrexate (n=63) or infliximab plus placebo (n=63). Methotrexate was initiated at 10 mg/week and escalated to 25 mg/week; infliximab (5 mg/kg) was given at weeks 1, 3, 7, 14, and every 8 weeks thereafter. Prednisone tapering began at week 1 and was completed by week 14. The primary endpoint—time to treatment failure, defined as absence of prednisone-free remission at week 14 or loss of remission through week 50—showed no significant difference: treatment failure occurred in 30.6% (combination) vs 29.8% (monotherapy) (P=0.63). Subgroup analyses by disease duration and CRP level found no benefit. Safety profiles were similar, and both regimens were well tolerated.
DIAMOND - Adalimumab plus Azathioprine in CD
In an open-label, prospective study, 176 biologic- and thiopurine-naïve Crohn’s disease patients were randomized to adalimumab monotherapy (n=85) or adalimumab plus azathioprine (25–100 mg daily; n=91) for 52 weeks. The primary endpoint was clinical remission at week 26; endoscopic severity was also assessed at weeks 26 and 52. Withdrawals due to active disease occurred in 21.2% (monotherapy) vs 7.7% (combination), while side effect–related withdrawals were 1.2% vs 16.5%, respectively. Remission rates at week 26 were similar (71.8% vs 68.1%; OR 0.84; p=0.63). However, endoscopic improvement at week 26 was higher with combination therapy (84.2% vs 63.8%; p=0.019). Combination therapy improved mucosal outcomes but not clinical remission and was associated with more adverse event–related discontinuations.
VEGA - Guselkumab plus Golimumab in UC
In a randomized, double-blind, proof-of-concept trial across nine countries, 214 adults with moderately-to-severely active ulcerative colitis were assigned to guselkumab plus golimumab, golimumab alone, or guselkumab alone. The primary endpoint was clinical response at week 12. Combination therapy achieved higher response (83%) versus golimumab (61%; p=0.0032) and numerically higher than guselkumab (75%; p=0.2155). Adverse events by week 50 occurred in 63% (combination), 76% (golimumab), and 65% (guselkumab), most commonly ulcerative colitis flares, upper respiratory infections, headache, anaemia, and nasopharyngitis. No deaths occurred during induction; serious events post-induction included one tuberculosis (combination) and one colon adenocarcinoma (guselkumab). Two unrelated deaths occurred after final dosing. Combination therapy improved short-term response without major new safety concerns.
EXPLORER - Vedolizumab plus Adalimumab plus Methotrexate in CD
In the phase 4, single-arm EXPLORER study, 55 biologic-naïve patients with newly diagnosed, moderate- to high-risk Crohn’s disease received triple therapy: vedolizumab, adalimumab, and methotrexate. The primary endpoint was endoscopic remission (SES-CD ≤2) at week 26; secondary endpoints included clinical remission (CDAI <150) at weeks 10 and 26, and safety. At week 26, 34.5% achieved endoscopic remission. Clinical remission occurred in 61.8% at week 10 and 54.5% at week 26. Bayesian analysis indicated high probability that triple therapy outperformed placebo (99.9%), with moderate probabilities over vedolizumab (86.3%) and adalimumab (71.4%) monotherapies. Six patients experienced serious adverse events. Triple biologic–immunomodulator therapy showed promising efficacy and an acceptable safety profile in early, high-risk Crohn’s disease.
VETO - Vedolizumab plus Tofacitinib in UC
In a prospective study of refractory ulcerative colitis unresponsive to anti-TNF and vedolizumab or tofacitinib monotherapy, patients with moderate-to-severe disease (Mayo 6–12) were randomized to vedolizumab (n=38) or tofacitinib (n=40). Non-responders (vedolizumab: 14; tofacitinib: 15) were offered combination vedolizumab–tofacitinib (VETO) therapy for 24 weeks; 24 received VETO, with a median prior second-line therapy duration of 21 weeks. At week 8, 17 achieved clinical response and 5 remission; 3 required colectomy. At week 24, 17 achieved response, 14 corticosteroid-free remission, and 7 endoscopic remission, with significant Mayo score improvement (mean difference 5.33; p<0.01). Two cases of pseudomembranous colitis resolved with vancomycin. No severe adverse events occurred. VETO showed meaningful efficacy and acceptable safety in this difficult-to-treat population.