A Review of Selected Presentations From Digestive Disease Week 2026
May 2-5, 2026 • Chicago, Illinois
Risankizumab Reduces Symptoms and Concomitant Therapy Use and Improves Health-Related Quality of Life in Adults With Crohn’s Disease: Year 1 Results From the ASPIRE-CD Study
Crohn’s disease (CD) is associated with reduced health-related quality of life (HRQOL), work impairment, psychological effects, and disability.1 According to the STRIDE-II framework, treatment targets for patients with CD should include reduced symptoms, absence of disability, and restoration of QOL.2
In clinical trials, the selective anti–interleukin-23 (IL-23) p19 antibody risankizumab demonstrated significant HRQOL improvements in patients with moderate to severe CD.3 The prospective, observational ASPIRE-CD study is evaluating the effects of risankizumab in a real-world setting in patients with active CD. The survey study was open to adults with CD in the United States who had initiated intravenous (IV) risankizumab and enrolled in the patient support program. Patients completed surveys at baseline and at weeks 2, 4, and every 8 weeks thereafter, reporting on CD-related signs and symptoms, extraintestinal manifestations (EIMs), fatigue, and use of concomitant therapies. In the initial report from the ASPIRE-CD study, risankizumab was associated with an improvement in HRQOL from baseline as early as 4 weeks after starting therapy and continuing through 12 weeks.4
Follow-up analyses on outcomes after 52 weeks of treatment in the ASPIRE-CD study were presented at DDW 2026.5,6 Data were reported for 286 patients at baseline, declining to 213 patients by the week 52 survey, at which point 86.4% of patients were continuing on risankizumab. The mean age at enrollment was 45.7 years; treatment history included use of corticosteroids (85.0%), biologics (74.8%), and upadacitinib (4.2%).
In their analysis, Charabaty and colleagues reported that at baseline, 72.0% of patients were receiving over-the-counter (OTC) treatments and 33.9% were receiving corticosteroids. Use of these concomitant therapies declined significantly starting as early as week 2 and declining to 48.8% for OTC treatments (P<.001) and to 7.0% for corticosteroids (P<.001) at week 52 (Figure 1).5
Significant and sustained improvements in abdominal pain, bowel urgency, and the incidence of liquid or very soft stools were also reported starting at week 2 of risankizumab and declining throughout the treatment period. Abdominal pain, assessed using a numerical scale rating, improved significantly from baseline at all posttreatment time points starting at week 2 as assessed by average pain and worst pain.
Bowel urgency in the last 7 days was reported by 76.2% of patients and bowel urgency in the last 24 hours was reported by 53.1% of patients. At week 52, these rates declined to 46.5% and 27.2%, respectively (P<.001 for each). Similar trends were reported for liquid/soft stools, reported in 88.1% (last 7 days) and 71.0% (last 24 hours) at baseline compared with 70.0% (last 7 days) and 49.8% (last 24 hours) at week 52.
Among patients with fatigue at baseline, risankizumab was associated with meaningful improvements in fatigue (defined as a ≥4-point increase in Functional Assessment of Chronic Illness Therapy score) that were reported by 43.0% of patients at week 4, increasing to 54.4% at week 52. Risankizumab was also associated with improvements in EIMs. Among 92 patients receiving treatment for EIMs at baseline, 50% reported relief after 52 weeks of risankizumab.
In their analysis, Keefer and colleagues presented HRQOL outcomes at week 52 in the ASPIRE-CD study.6 By week 12, patients reported significant improvements in sexual health and in CD-specific work productivity and activity impairment that were sustained or continued through the 52-week treatment period. Patients also reported improvements in HRQOL as assessed by the physical component of the Short-Form 12-Item Survey-version that were significant by week 4 (P<.001) and were sustained during the treatment period out to week 52 (P<.0001).
Investigators noted that HRQOL results were either consistent or slightly improved among patients who continued risankizumab at each visit. At 52 weeks, 55.9% of patients reported that their life enjoyment was either moderately or much improved, and 68.5% of patients were either very satisfied or extremely satisfied with their CD treatment.
References
1. Williet N, Sarter H, Gower-Rousseau C, et al. Patient-reported outcomes in a French nationwide survey of inflammatory bowel disease patients. J Crohns Colitis. 2017;11(2):165-174.
2. Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology. 2021;160(5):1570-1583.
3. Peyrin-Biroulet L, Ghosh S, Lee SD, et al. Effect of risankizumab on health-related quality of life in patients with Crohn’s disease: results from phase 3 MOTIVATE, ADVANCE and FORTIFY clinical trials. Aliment Pharmacol Ther. 2023;57(5):496-508.
4. Keefer L, Abraham B, Griffith JM, et al. Real-world impact of risankizumab on health-related quality of life in adults with Crohn’s disease: initial results from the ASPIRE-CD study. Abstract P5426. Presented at: American College of Gastroenterology 2025; October 24-29, 2025; Phoenix, Arizona.
5. Charabaty A, Griffith JM, Yang M, et al. Risankizumab reduces Crohn’s disease-related symptoms and concomitant therapy use in adults with Crohn’s disease: year 1 results from the ASPIRE-CD study [DDW abstract Sa1504]. Gastrointest Endosc. 2026;103(5):S-958-S-959.
6. Keefer L, Griffith JM, Yang M, et al. Risankizumab improves health-related quality of life in adults with Crohn’s disease: year 1 results from the ASPIRE-CD study [DDW abstract Mo1674]. Gastrointest Endosc. 2026;103(5):S-1240-S-1241.
Guselkumab for Perianal Fistulizing Crohn’s Disease: Week 24 Results From the Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter FUZION Study
Perianal fistulas are a severe complication of CD that is associated with chronic pain, persistent drainage and discharge, a risk of fecal incontinence, and impaired QOL.1 Perianal fistulas are present in approximately 9% of patients at diagnosis and develop in at least a quarter of patients in the first 2 decades after diagnosis.1
There is a need for more effective therapies for perianal fistulizing CD, as systemic therapies induce durable remission in only about one-third of patients, and most patients require surgery.1 There has been little progress in medical therapies for fistulizing CD. The last successful randomized, placebo-controlled, international trial was the ACCENT-2 trial of maintenance infliximab, published more than 20 years ago.2
At DDW 2026, Peyrin-Biroulet and colleagues presented 24-week results from the randomized, double-blind, placebo-controlled phase 3 FUZION trial evaluating guselkumab in patients with perianal fistulizing CD.3 The treat-through study enrolled adults with at least 1 active draining perianal fistula confirmed by blinded central imaging review and active CD (Crohn’s Disease Activity Index [CDAI] score <350). Patients were required to have an inadequate response or intolerance to oral corticosteroids or immunosuppressants or up to 2 advanced therapy classes and to be refractory to antibiotics.
Patients were randomly assigned 2:2:1 to 12 weeks of IV induction treatment with guselkumab 200 mg every 4 weeks (Q4W) or placebo, followed by an extended treatment phase of guselkumab 200 mg subcutaneously (SC) Q4W, guselkumab 100 mg SC every 8 weeks (Q8W), or placebo SC Q4W (in patients initially assigned to placebo) for up to a total treatment period of 96 weeks.
The mean age of enrolled patients was 36.5 years; 71.7% were male and the median duration of CD was 6.29 years. At baseline, 33.9% of patients were biologic-naive, 29.4% had proctitis, and 25.9% had at least 1 fistula-related surgery during screening. Concomitant medications included immunosuppressants (29.7%), 5-aminosalicylic acid (25.5%), and corticosteroids (7.7%).
At week 24, the primary endpoint of combined fistula remission assessed clinically and radiologically (by magnetic resonance imaging [MRI]) was attained in 28.3% of patients receiving guselkumab 100 mg SC Q8W and 27% of patients receiving guselkumab 200 mg SC Q4W, compared with 10.3% with placebo (P=.007 and P=.013, respectively) (Figure 2).
All patients with a clinically assessed fistula remission also attained radiologic absence of collections greater than 2 cm. A clinically assessed fistula response (defined as a ≥50% reduction from baseline in the number of open or draining perianal fistulas) was attained in 32.7% of patients receiving guselkumab 100 mg SC Q8W and 35.7% of patients receiving guselkumab 200 mg SC Q4W, compared with 13.8% of patients receiving placebo (P=.008 and P=.003, respectively).
In the safety analysis, at least 1 adverse event (AE) occurred in 68.4% of patients receiving guselkumab and 82.8% of patients receiving placebo; serious AEs (SAEs) were reported in 8.3% and 13.8% of patients, respectively. At least 1 infection was reported in 33.3% of patients receiving guselkumab and 46.6% of patients receiving placebo; the proportion of patients developing at least 1 serious infection was 4.4% and 3.4%, respectively.
Treatment discontinuations owing to AEs occurred in 4.8% of patients receiving guselkumab and 8.6% of patients receiving placebo. There were no reports of opportunistic infections, anaphylactic reactions, major adverse cardiovascular events, clinically important hepatic disorders, venous thromboembolic events, or deaths. One patient developed a B-cell lymphoma that was not considered related to the study drug.
References
1. Lee JJ, Lightner AL. Management and treatment of perianal fistulizing Crohn’s disease. Clin Exp Gastroenterol. 2025;18:291-303.
2. Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn’s disease. N Engl J Med. 2004;350(9):876-885.
3. Peyrin-Biroulet L, Jairath V, Hart A, et al. Guselkumab for perianal fistulizing Crohn’s disease: week 24 results from the phase 3, randomized, double-blind, placebo-controlled, multicenter FUZION study [DDW abstract 1058b]. Gastroenterology. 2026;170(6):S-2857.
Updates on Upadacitinib in Crohn’s Disease: Long-Term Efficacy Based on Prior Biologic Use and Real-World Evidence in Patients With Perianal Lesions
The oral selective Janus kinase inhibitor upadacitinib has demonstrated efficacy as induction and maintenance treatment in patients with moderate to severe CD in the U-EXCEL and U-EXCEED trials, and the long-term extension (LTE) U-ENDURE study.1 Analyses presented at DDW 2026 provided updates on the efficacy and safety of upadacitinib in patients with CD.
Atreye and colleagues reported results of a post-hoc analysis evaluating the efficacy of upadacitinib in the U-ENDURE LTE based on response or intolerance to prior biologic therapy at baseline.2 In the LTE, patients who completed 52 weeks of maintenance therapy in U-ENDURE continued their assigned treatment (upadacitinib 15 mg or 30 mg once daily or placebo) for an additional 96 weeks.
The current analysis included 189 patients with prior inadequate response or intolerance to biologic therapy (Bio-IR) and 91 patients without prior inadequate response or intolerance to biologic therapy (nonBio-IR) who received upadacitinib at 15 mg or 30 mg once daily.
After 3 years of LTE treatment, both clinical and endoscopic outcomes were sustained or improved over time in the Bio-IR and nonBio-IR groups, and remission rates were similar regardless of Bio-IR status. Week 96 CDAI clinical remission rates with upadacitinib 15 mg and 30 mg were 86.4% and 83.1%, respectively, in the Bio-IR cohort compared with 77.8% and 89.7%, respectively, in the nonBio-IR cohort. Week 96 stool frequency/abdominal pain score clinical remission rates with upadacitinib 15 mg and 30 mg were 88.6% and 75.0%, respectively, in the Bio-IR cohort and 74.1% and 89.7%, respectively, in the nonBio-IR cohort. At week 96, the endoscopic remission rate in the Bio-IR cohort was 47.6% and 51.9% with upadacitinib 15 mg and 30 mg, respectively, compared with 56.5% and 59.0%, respectively, in the nonBio-IR cohort.
Investigators concluded that the findings indicate long-term efficacy with upadacitinib in patients with CD with a prior inadequate response or intolerance to biologic therapy.
Another analysis on the use of upadacitinib in patients with CD focused on the subset of patients with perianal disease. A post-hoc analysis from the U-EXCEL, U-EXCEED, and U-ENDURE trials had previously demonstrated a significant efficacy benefit with upadacitinib in patients with fistulizing disease.3 However, its effectiveness in a real-world setting had not been evaluated.
A retrospective, multicenter real-world analysis was therefore undertaken by Richard and colleagues to evaluate the efficacy and safety of upadacitinib in patients with refractory perianal CD receiving care across 13 centers in France.4 The analysis included 59 patients with a median age of 38 years (range, 29-47 years); 27% of patients had primary perianal lesions and 73% had simple or complex fistulas. Patients had received a median of 3 prior biologic therapies (interquartile ratio, 3-5).
Upadacitinib was initiated at 45 mg once daily and the dose was adjusted as needed. At 6 months, clinical remission occurred in 26% of patients with fistulizing perianal lesions (n=43) and in 25% of patients with isolated anal ulcerations (n=16) (Figure 3). These were sustained at 12 months. No parameters were identified that were significantly associated with clinical remission of fistulizing disease at 12 months.
The clinical response rate for patients with fistulizing perianal lesions was 49% at 6 months and 30% at 12 months, and the clinical response rate for patients with isolated anal ulcerations was 31% and 38%, respectively. Radiologic responses were observed in 9 of 13 evaluated patients with fistulizing perianal CD after a median of 29 weeks, for a radiologic response rate of 69%.
AEs were reported in 25% of patients; the most frequent AE was acne, reported in 12%. SAEs were reported in 3 patients (5%), all associated with CD exacerbation.
References
1. Loftus EV Jr, Panés J, Lacerda AP, et al. Upadacitinib induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2023;388(21):1966-1980.
2. Atreya R, Panaccione R, Louis E, et al. Long-term efficacy of upadacitinib in patients with moderate-to-severe Crohn’s disease and prior biologic use [DDW abstract Tu1644]. Gastroenterology. 2026;170(6):S-1341-S-1342.
3. Colombel JF, Lacerda AP, Irving PM, et al. Efficacy and safety of upadacitinib for perianal fistulizing Crohn’s disease: a post hoc analysis of 3 phase 3 trials. Clin Gastroenterol Hepatol. 2025;23(6):1019-1029.
4. Richard N, Seksik P, Altwegg R, et al. One-year efficacy of upadacitinib in perianal Crohn’s disease: a multicenter cohort study [DDW abstract Tu1658]. Gastroenterology. 2026;170(6):S-1349.
Extraintestinal Manifestations in Participants With Moderately to Severely Active Crohn’s Disease: Results From the Phase 3 GALAXI 2 and 3 Studies
Guselkumab is an IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64 on IL-23-producing inflammatory cells.1 The two identical phase 3 trials, GALAXI-2 and GALAXI-3, showed significant efficacy with guselkumab in patients with moderately to severely active CD.2 Guselkumab administered as IV induction followed by SQ maintenance therapy was more effective than placebo and ustekinumab as assessed by multiple endpoints.
An analysis presented at DDW 2026 evaluated changes in EIMs in patients with CD receiving guselkumab or placebo in the GALAXI-2 and GALAXI-3 trials.3 EIMs occur in up to half of patients with inflammatory bowel disease (IBD) and can affect multiple organ systems, including the musculoskeletal system, skin, eyes, vascular systems, and liver.4 The current analysis by Rubin and colleagues focused on changes in the incidence of EIMs in the joints (arthritis/arthralgia), skin (erythema nodosum/pyoderma gangrenosum), and eyes (iritis/uveitis) over 48 weeks of treatment with guselkumab or placebo.3
At baseline, EIMs were present in 34.5% of patients in the guselkumab arm and 42.6% in the placebo arm. These were most commonly in the joints (89.1% and 90.5%, respectively), followed by the skin (18.4% and 25.4%, respectively) and the eyes (5.5% and 3.2%, respectively).
At the end of the 12-week induction therapy, the overall rate of EIM resolution was 59.2% in the guselkumab arm and 42.9% in the placebo arm (nominal P=.023). This included resolution of joint EIMs in 55.2% and 33.3% of patients, respectively (P=.004), and resolution of skin EIMs in 75.7% and 56.2%, respectively (P=.157). De novo EIMs occurred in 2.6% and 8.1% of patients, respectively (nominal P=.001) (Figure 4).
At week 48, after 12 weeks of induction treatment and 36 weeks of maintenance therapy, the incidence of joint and skin EIMs decreased significantly from baseline in both guselkumab dosing groups. Specifically, the proportion of patients with arthritis/arthralgia decreased from 35.7% to 12.6% (P<.001) with guselkumab 100 mg SC Q8W and from 26.0% to 10.1% (P<.001) with guselkumab 200 mg SC Q4W. The proportion of patients with erythema nodosum/pyoderma gangrenosum decreased from 8.0% to 1.0% (P<.001) with guselkumab 100 mg SC Q8W and from 4.7% to 0.0% (P<.001) with guselkumab 200 mg SC Q4W. The incidence of de novo EIMs was low both for joint manifestations (2.7-2.8%) and skin manifestations (0-0.7%).
Among patients with EIMs at baseline, 67.0% attained 90-day corticosteroid-free resolution of joint EIMs at week 48, and 91.9% attained corticosteroid-free resolution of skin EIMs. Similar outcomes were observed in the subset of patients with EIMs who were receiving corticosteroids at baseline, including 63.8% for joint EIMs and 83.3% for skin EIMs.
References
1. Sachen KL, Hammaker D, Sarabia I, et al. Guselkumab binding to CD64+ IL-23-producing myeloid cells enhances potency for neutralizing IL-23 signaling. Front Immunol. 2025;16:1532852.
2. Panaccione R, Feagan BG, Afzali A, et al. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn’s disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025;406(10501):358-375.
3. Rubin DT, Hisamatsu T, Van Rampelbergh R, et al. Extraintestinal manifestations in participants with moderately to severely active Crohn’s disease: results from the phase 3 GALAXI 2 and 3 studies [DDW abstract 981]. Gastrointest Endosc. 2026;103(5):S-915-S-916.
Real-World Effectiveness and Safety of Risankizumab Induction and Maintenance Therapy in Pediatric Patients With Crohn’s Disease:
A Multicenter Retrospective Analysis
There are limited biologic therapies available for pediatric patients with CD. The IL-12 and IL-23 inhibitor ustekinumab has demonstrated efficacy and safety in pediatric patients both in clinical trials (eg, UNITI Jr) and in real-world analyses (eg, REALITI).1,2 In the SEQUENCE trial, the selective IL-23 inhibitor demonstrated superior efficacy compared with ustekinumab in adults with moderate to severe CD.3 However, risankizumab has not been formally evaluated in a pediatric population.
At DDW 2026, Spencer and colleagues presented results of a real-world retrospective analysis evaluating the effectiveness and safety of risankizumab as induction and maintenance therapy in pediatric patients with CD. Between June 2022 and March 2025, the global study enrolled 96 pediatric patients with confirmed CD who started risankizumab for CD across 10 centers. The indication and dosing were at the physician’s discretion. Patients with concomitant advanced therapy at initiation, and those with prior ileocecal resection and/or current ostomy at baseline were excluded.
Of the 96 pediatric patients, 68 had clinically active CD (weighted pediatric CDAI [wPCDAI] of ≥12.5). The remaining 28 patients had inactive disease at the start. The median age was 15 years and ranged from 7 to 17 years. Treatment history included 49% with failure of 2 or more advanced therapies, 47% with prior infliximab exposure, 38% with prior ustekinumab exposure, and 10% who were advanced therapy-naive. In patients with active disease, the median baseline a weighted pediatric CDAI was 35.
The primary outcome, week 12 corticosteroid-free remission (CFR; wPCDAI <12.5), was attained in 41% of patients. Clinical response (defined as a ≥17.5-point decrease in wPCDAI) occurred in 54% of patients. From baseline to week 12, the median
wPCDAI decreased from 35 to 16 (P<.001) and median C-reactive protein (CRP) levels decreased from 4.0 mg/L to 2.1 mg/L. At week 12, 66% of patients attained total CRP remission, 32% attained a deep remission, defined as a CFR and a CRP remission, and 40% attained an intestinal ultrasound (IUS) remission (Figure 5).
In subset analyses, risankizumab demonstrated high effectiveness in patients naive to advanced therapies, with 7 of 7 patients attaining CFR. In patients previously treated with ustekinumab, risankizumab effectiveness was maintained, with an odds ratio (OR) for attaining CFR not significantly different in ustekinumab-exposed and ustekinumab-naive patients (OR, 1.08; P=.88). However, prior exposure to anti-TNF was associated with lower risankizumab effectiveness, as prior infliximab was associated with a lower rate of attaining CFR (OR, 0.34; P=.06). Investigators concluded from these findings that selective p19 inhibition is active even after failure of broad p40 blockade, although earlier sequencing of biologics may optimize outcomes.
An analysis of outcomes based on inflammatory burden found that a lower baseline erythrocyte sedimentation rate (ESR) was independently associated with a higher likelihood of attaining postinduction CFR (OR, 0.97 per mm/hr; P=.01). An optimal ESR threshold of 28.5 mm/hr was identified, with lower ESR associated with a higher likelihood of remission. In contrast, baseline CRP level was not associated with attaining CFR. The researchers noted that obtaining routine ESR levels could potentially be used for risk stratification, identifying patients who could benefit from closer monitoring or optimization of therapy.
Baseline height and growth impairment also predicted clinical outcomes at week 12. A history of impaired growth—present in 31% of patients with clinically active CD at baseline—was associated with a trend toward a lower likelihood of attaining week 12 CFR (OR, 0.33; P=.06). In contrast, a better baseline height z-score was associated with a higher likelihood of attaining week 12 CFR (OR, 1.93; P=.02).
Among patients with clinically active disease at baseline, 87% of patients remained on therapy after a median of 53 weeks of follow-up. The CFR rate increased from 41% at week 12 to 53% at week 30 and 55% at week 54. Among the 28 patients with a CFR at week 12, remissions were sustained at week 30 in 82% of patients and at week 54 in 71%.
Among the full cohort, there were no SAEs, including opportunistic infections, malignancies, or thromboembolic events. AEs that were managed without necessitating a change in therapy included transient alanine aminotransferase elevations, paradoxical atopic dermatitis, and mild hives. Two AEs were managed with changes in therapy: 1 case of reported brain fog that resolved after reducing the dose from 360 mg to 180 mg and 1 case of fatigue and arthralgia with the first IV dose in a patient who had the same reaction to the first dose of adalimumab; this patient discontinued risankizumab.
Investigators concluded that risankizumab was highly effective in pediatric patients with refractory CD and demonstrated a favorable risk-benefit profile. Prospective trials are warranted to optimize dosing and to evaluate long-term outcomes.
References
1. De Greef E, Turner D, Kierkuś J, et al. Ustekinumab therapy for moderately to severely active pediatric Crohn’s disease: UNITI Jr study safety and efficacy results in patients weighing at least 40 kg. J Crohns Colitis. 2026;20(3):jjag011.
2. Steiner SJ, Adler J, Saeed SA, et al. Effectiveness and safety of ustekinumab in pediatric Crohn’s disease: Results of the REALITI study. J Pediatr Gastroenterol Nutr. 2026;82(5):1242-1250.
3. Peyrin-Biroulet L, Chapman JC, Colombel JF, et al. Risankizumab versus ustekinumab for moderate-to-severe Crohn’s disease. N Engl J Med. 2024;391(3):213-223.
4. Spencer EA, Buck Q, Collen LV, et al. Real-world effectiveness and safety of risankizumab induction and maintenance therapy in pediatric patients with Crohn’s disease: a multicenter retrospective analysis [DDW abstract 99]. Gastrointest Endosc. 2026;103(5):S-866.
Mirikizumab Demonstrated Long-Term Efficacy and Favorable Safety in Week 52 Endoscopic Responders and Nonresponders With Crohn’s Disease: 3-Year VIVID-2 Open-Label Extension Interim Results
The anti-IL-23p19 antibody mirikizumab demonstrated efficacy and safety in patients with moderately to severely active CD as induction and maintenance therapy for up to 52 weeks in the randomized, placebo-controlled, phase 3 VIVID-1 trial and showed durable improvements with mirikizumab for up to 104 weeks in the VIVID-2 open-label extension (OLE) study.1,2
Laharie and colleagues reported long-term outcomes with mirikizumab from the VIVID-2 OLE based on week 52 endoscopic responses in the VIVID-1 trial.3,4 A total of 251 patients entered the OLE with an endoscopic response to mirikizumab at week 52 and 181 patients entered the OLE without an endoscopic response. Patients with an endoscopic response continued to receive mirikizumab 300 mg SC Q4W, whereas patients without an endoscopic response received
reinduction with IV mirikizumab 900 mg Q4W for 12 weeks. Patients without a clinical benefit at week 12 of reinduction discontinued treatment and patients with a clinical benefit at week 12 switched to a maintenance dose of mirikizumab 300 mg SC Q4W.
Overall, 89.6% of patients without an endoscopic response at week 52 were in clinical response at that time, and this clinical benefit was often maintained over the 3-year OLE period. At week 152, these patients had high rates of CDAI remission (89.7%), corticosteroid-free CDAI remission (87.7%), bowel urgency clinically meaningful improvement (79.9%), and bowel urgency remission (72.5%).3 In addition, a proportion of patients who entered VIVID-2 without attaining clinical endpoints achieved these endpoints by week 152, including CDAI remission (60.5%), corticosteroid-free CDAI remission (58.7%), bowel urgency clinically meaningful improvement (35.1%), and bowel urgency remission (28.6%) (Figure 6).
Although endoscopic outcomes were not assessed at year 3, 36.1% of patients without an endoscopic response at week 52 had attained an endoscopic response by year 2 (week 104). Among patients who had attained a week 52 endoscopic response, mirikizumab continued to demonstrate efficacy over the 3-year OLE.4 The majority of clinical endpoints attained at week 52 were maintained through week 152, including 92.4% of CDAI remissions, 91.2% of corticosteroid-free CDAI remissions, 82.1% of bowel urgency clinically meaningful improvements, and 71.7% of bowel urgency remissions. Moreover, as was observed in the nonresponder cohort, a proportion of patients who had not reached specific endpoints by week 52 did so by week 152, including CDAI remission in 72.5%, corticosteroid-free CDAI remission in 73.9%, bowel urgency clinically meaningful improvement in 53.8%, and bowel urgency remission in 28.1%. Levels of inflammatory biomarkers also improved over the OLE in both cohorts of patients.3,4
Safety analyses revealed no new concerns with mirikizumab in either cohort.3,4 The exposure-adjusted incidence rate (EAIR) of SAEs was 6.8 per 100 patient-years (PY) in the responder cohort and 9.3 per 100 PY in the nonresponder cohort. The EAIR of infections was 37.6 and 39.8 per 100 PY, respectively. These included serious infections at an EAIR of 1.1 and 1.8 per 100 PY, respectively, and opportunistic infections in 1.9 and 2.1 per 100 PY, respectively. There was one death attributed to COVID-19 in an unvaccinated individual.
References
1. Ferrante M, D’Haens G, Jairath V, et al. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436.
2. Sands BE, Barnes EL, D’Haens G, et al. Mirikizumab long-term efficacy and safety in patients with Crohn’s disease: results from the VIVID-2 open-label extension trial [published online March 5, 2026]. Clin Gastroenterol Hepatol. doi:10.1016/j.cgh.2026.01.049
3. Laharie D, Clemow DB, Sands BE, et al. Mirikizumab demonstrated long-term efficacy and favorable safety in week 52 endoscopic nonresponders with Crohn’s disease: 3-year VIVID-2 open-label extension interim results [DDW abstract Sa1499]. Gastrointest Endosc. 2026;103(5):S-956.
4. Laharie D, Clemow DB, Sands BE, et al. Mirikizumab demonstrated sustained and durable long-term efficacy and favorable safety in week 52 endoscopic responders with Crohn’s disease: 3-year VIVID-2 open-label extension interim results [DDW abstract Mo1524]. Gastroenterology. 2026;170(6):S-1170-S-1171.