Skyrizi (risankizumab-rzaa) / AbbVie, Boehringer Ingelheim - LARVOL DELTA

Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries. (PubMed, Paediatr Drugs) - "Efforts to expedite approval of new agents in pIBD are warranted to ensure timely access to effective medications. Consideration for novel trial designs alongside continued engagement with regulatory bodies, sponsors, and the academic pIBD community is essential to advance drug approvals for pIBD."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics

COMPARATIVE STUDY ON THE EFFECTIVENESS, DURABILITY, AND SAFETY OF UPADACITINIB VERSUS RISANKIZUMAB AFTER ANTI-TNF FAILURE IN CROHN'S DISEASE: THE U-PARIS STUDY OF ENEIDA (UEGW 2026) - "Aims & Aims: to compare the durability and effectiveness of UPA and RSK after biologic failure in CD; to identify risk factors for relapse and for therapy discontinuation; and to explore safety profile of UPA and RSK in this scenario. adult patients from the prospectively-maintained ENEIDA registry of GETECCU who received UPA or RSK as second- (after 1 anti-TNF) or third-line (after 2 anti-TNFs, 1 anti-TNF+vedolizumab, or 1 anti-TNF+ustekinumab) with ≥12 weeks of follow-up, were included. UPA and RSK are effective options after biologic failure in CD patients. Both agents showed relatively high treatment durability with greater persistence observed for RSK in third-line. CD behaviour and UPA treatment (vs."

Clinical • Acne Vulgaris • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Solid Tumor

SIX-MONTHS EFFECTIVENESS AND SAFETY OF UPADACITINIB AFTER FAILURE OF RISANKIZUMAB IN CROHN'S DISEASE: A MULTICENTER REAL-WORLD COHORT STUDY (UEGW 2026) - "Median age was 40 years (IQR, 32–47), 49 patients (58%) were male, median number of prior advanced therapies was 5 (IQR, 3–6), 65 (76%) had prior exposure to ustekinumab, and 13 (15%) had a stoma. In this real-world cohort of highly refractory CD patients, upadacitinib demonstrated substantial effectiveness after risankizumab failure, with more than half of patients achieving clinical remission at 24 weeks. These findings support upadacitinib as a valuable therapeutic option in this difficult-to-treat population."

Clinical • Real-world • Real-world evidence • Acne Vulgaris • Crohn's disease • Gastroenterology • Herpes Zoster • Immunology • Inflammatory Bowel Disease • Musculoskeletal Pain • Retinal Disorders • Retinal Vein Occlusion • Squamous Cell Carcinoma • Varicella Zoster • CRP

RISANKIZUMAB OUTPERFORMED USTEKINUMAB FOR STEROID-FREE CLINICAL AND BIOCHEMICAL REMISSION IN REAL-WORLD PATIENTS WITH CROHN'S DISEASE AFTER TUMOUR NECROSIS FACTOR ANTAGONIST EXPOSURE: A MULTICENTRE BAYESIAN ANALYSIS - REAL-SEQUENCE (AN IG-IBD STUDY) (UEGW 2026) - "In this large, real-world cohort of anti-TNF-experienced patients with CD, RZB was associated with a significantly higher probability of achieving SFCR at 6 months than UST, corroborating the findings from the SEQUENCE trial and supporting their external validity of randomized evidence in an unselected clinical population. By combining IPTW with a Bayesian framework formally incorporating RCT evidence as prior knowledge, this study provides methodologically rigorous real-world validation, supporting the positioning of RZB over UST in anti-TNF-experienced CD patients in clinical practice."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology

EFFICACY AND SAFETY OF RISANKIZUMAB SUBCUTANEOUS INDUCTION IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE: WEEK 12 RESULTS FROM THE PHASE 3 AFFIRM STUDY (UEGW 2026) - P3 | "Enrolment of patients who were ustekinumab (UST)-IR or ≥ 3 AT-IR were each capped at 20%. In the overall AFFIRM population, patients with moderately to severely active CD treated with 12-weeks of RZB SC induction therapy achieved the coprimary endpoints of CDAI clinical remission and endoscopic response at significantly higher rates than those receiving PBO. Approximately three quarters of AT-naïve patients achieved clinical remission at this early timepoint. Both AT-naïve and AT-IR (which included UST-IR, and JAK-IR) achieved high rates of efficacy at numerically higher rates with RZB SC induction than PBO."

Clinical • P3 data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

INFLAMMATORY BIOMARKER REDUCTIONS AND IMPROVEMENTS IN CLINICAL AND ENDOSCOPIC OUTCOMES WITH RISANKIZUMAB THROUGH 148 WEEKS OF TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE: A POST HOC ANALYSIS FROM PART 2 OF THE SEQUENCE TRIAL (UEGW 2026) - P3 | "In this post hoc analysis of patients with moderately to severely active CD, long-term treatment with RZB led to simultaneous improvements in clinical, endoscopic, and inflammatory biomarker outcomes that were sustained through week 148. These results highlight the potential of RZB to provide long-term, comprehensive disease control in the management of CD."

Biomarker • Clinical • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • CRP

EFFICACY AND SAFETY OF RISANKIZUMAB RESCUE TREATMENT IN PATIENTS WITH MODERATE-TO-SEVERE CROHN'S DISEASE: RESULTS FROM PATIENTS WHO DEMONSTRATED INADEQUATE RESPONSE DURING THE 4-YEAR FORTIFY OPEN-LABEL LONG-TERM EXTENSION (UEGW 2026) - P3 | "Among pts with moderate-to-severe CD who experienced IR to RZB maintenance therapy during the FORTIFY OLE, many demonstrated clinically meaningful improvements in symptomatic and endoscopic outcomes after receiving RZB rescue treatment, durable to two years and beyond. No new safety risks for RZB were identified with rescue treatment, supporting its long-term use in treating CD."

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

EFFICACY OF RISANKIZUMAB BY CROHN'S DISEASE LOCATION: RESULTS FROM 144 WEEKS OF THE FORTIFY OPEN-LABEL EXTENSION STUDY (UEGW 2026) - P3 | "Efficacy outcomes were generally consistent or improved in all disease locations through 96 or 144 weeks of RZB treatment in the FORTIFY OLE despite including a refractory patient population. These results demonstrate the prolonged beneficial effects of RZB for patients with moderately to severely active CD across disease locations among maintenance responders, emphasizing the durability of effect with long-term use."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

SAFETY AND EFFECTIVENESS OF ADVANCED THERAPIES IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND COMPENSATED CIRRHOSIS. HEP-IBD STUDY. A STUDY FROM THE YOUNG GROUP OF GETECCU (UEGW 2026) - "Consecutive IBD patients with an established diagnosis of compensated cirrhosis (Child A or Child B≤8) who received at least induction with infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, tofacitinib, upadacitinib, risankizumab, mirikizumab or filgotinib between January 2000 and September 2024, were eligible. These data suggest that the use of advanced therapies is feasible in patients with compensated cirrhosis, with acceptable treatment persistence rates and a low risk of hepatic decompensation, without clear differences between anti-TNF and non–anti-TNF therapies."

Clinical • Metastases • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatocellular Cancer • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Liver Cirrhosis • Liver Failure • Metabolic Dysfunction-Associated Steatotic Liver Disease • Solid Tumor • Ulcerative Colitis

EFFECTIVENESS OF BIOLOGIC THERAPY IN POSTOPERATIVE ENDOSCOPIC RECURRENCE OF CROHN'S DISEASE: A MULTICENTER REAL-WORLD STUDY (UEGW 2026) - "Overall, 28.57% of patients had previously received postoperative prophylaxis, and 54.3% were biologic-naïve.Biologic therapies used included Infliximab (23.60%), Adalimumab (24.22%), Vedolizumab (18.63%), Ustekinumab (25.47%), Upadacitinib (2.48%), and Risankizumab (5.59%). Endoscopic postoperative recurrence remains a challenging condition in CD. In this cohort, patients with more severe endoscopic recurrence showed a higher probability of treatment response, suggesting a potential greater reversibility of inflammatory activity in the presence of more active endoscopic disease."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DOSE ESCALATION OF INTERLEUKIN (IL)-23 INHIBITORS IN INFLAMMATORY BOWEL DISEASE: A SYSTEMATIC REVIEW OF EFFICACY AND SAFETY (UEGW 2026) - "We conducted a systematic review of studies reporting dose escalation of risankizumab, mirikizumab, or guselkumab in adult patients with Crohn's disease (CD) or ulcerative colitis (UC). In this first systematic review of IL-23 inhibitors dose escalation in IBD, dose escalation was effective and well-tolerated, recapturing clinical response in the majority of patients with inadequate primary or secondary response to standard dosing. These findings support dose escalation as a viable strategy in clinical practice, though prospective studies are needed to define optimal escalation protocols and identify predictors of response."

Clinical • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A • NCAM1

DISEASE CLEARANCE AS A TREATMENT TARGET IN PATIENTS WITH CHRONIC INFLAMMATORY POUCH CONDITIONS: A MULTI-NATIONAL RETROSPECTIVE STUDY (UEGW 2026) - "Nineteen had normal pouch histology (disease clearance), while 20 had histologic evidence of inflammation despite normal endoscopic appearance.Biologic agents at the time of the index pouchoscopy included Vedolizumab (n=15), Infliximab (n=11), Ustekinumab (n=7), Adalimumab (n=5), and Risankizumab (n=1).Biologic treatment persistence was similar and high in both groups: 16/19 (84%) among patients with disease clearance and 19/20 (95%) among those with histologic inflammation (p=0.34).In the disease clearance group, treatment discontinuation occurred in 3 patients, all due to elective treatment de-escalation or safety concerns. This study is the first to investigate disease clearance as a potential treatment target in patients with chronic inflammatory pouch disorders. No meaningful differences in clinical outcomes were observed between patients who achieved disease clearance and those who had endoscopic remission with persistent histologic inflammation. Larger studies..."

Retrospective data • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis

SAFETY OF INFANT VACCINATION AFTER MATERNAL BIOLOGIC EXPOSURE DURING PREGNANCY OR BREASTFEEDING IN INFLAMMATORY BOWEL DISEASE: A PROSPECTIVE MULTICENTRE COHORT STUDY OF THE DUMBO REGISTRY OF GETECCU (UEGW 2026) - "During pregnancy, 437 infants were exposed to biologics, including anti-tumour necrosis factor (TNF) agents in 304, ustekinumab in 97, vedolizumab in 33, and risankizumab or mirikizumab in 3. In this large prospective cohort of children born to mothers with IBD, vaccination, including live-attenuated vaccines, showed a favourable safety profile after maternal biologic exposure during pregnancy or breastfeeding. These real-world data support routine infant vaccination and may help reduce unnecessary delays, particularly for live vaccines."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Measles • Mumps • Rotavirus Infections • Rubella • Varicella Zoster

DEVELOPMENT AND CHARACTERIZATION OF SL-846: A HALF-LIFE EXTENDED, DUAL-RECEPTOR (DR3 X IL23RA) TARGETING BISPECIFIC ANTIBODY (UEGW 2026) - "However, TL1A blocking monoclonal antibodies cause high rates of anti-drug antibody formation, and this propensity was compounded in a bispecific format, leading to >95% ADA, nearly all neutralizing, in the case of AMG966 (TL1A x TNFα) and RG6730 (TL1A x IL-23p40)...In healthy donor and IBD patient PBMC assays, SL-846 blocked combined TL1A- and IL-23–induced IFNγ, IL-17A/F and IL-22 production with efficacy equivalent to individual monotherapy agents or combined SL-325 (anti-DR3 mAb) plus Risankizumab or icotrokinra treatment controls... Together, these data demonstrate that SL-846 is a potent, dual-specific antagonist of TL1A and IL-23 signaling. Its dual-receptor targeting and durable antagonism support its potential as a first-in-class bispecific therapeutic with superior efficacy prospects for the treatment of IL-23 and TL1A-driven inflammatory diseases."

Bispecific • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • CD123 • IFNG • IL17A • IL22 • IL23A • TNFA

SINGLE CELL SIGNATURES OF TH-17 CELLS IN POSTOPERATIVE RECURRENCE IN CROHN'S DISEASE (UEGW 2026) - "(3,4) Ustekinumab (USTE) and risankizumab (RISA) are approved therapies for CD that modulate IL-23 signalling through different targets (p40 vs p19). Single-cell profiling of ileal mucosal biopsies in postoperative CD demonstrated treatment-associated changes in the Th17 compartment after USTE or RISA therapy. Baseline Th17 transcriptional signatures may help identify patients less likely to achieve endoscopic response to IL-23 targeted treatments."

IO biomarker • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • HES4 • IL23A • SOCS3 • STING

EARLY EVOLUTION OF ULTRASOUND LESIONS IN PATIENTS WITH CROHN'S DISEASE TREATED WITH RISANKIZUMAB: SUBANALYSIS OF THE MULTICENTER PROSPECTIVE SKYNETICS STUDY (UEGW 2026) - "In this prospective multicenter study including unselected patients with Crohn's disease previously exposed to at least one anti-TNF, risankizumab achieved early clinical, biochemical, and transmural effectiveness, supporting its use in this clinical situation."

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

INTESTINAL ULTRASOUND FOR MONITORING ADVANCED THERAPIES IN CROHN'S DISEASE: REAL-WORLD EVIDENCE FROM A PROSPECTIVE COHORT (UEGW 2026) - "Aims & We conducted a monocentric, retrospective analysis of a CD patients cohort starting advanced therapies (adalimumab, vedolizumab, ustekinumab and risankizumab). In a real-world cohort, advanced therapies were associated with significant improvements in both clinical and ultrasound parameters. However, the modest concordance between IUS and clinical/biochemical changes highlights the complementary role of imaging in disease monitoring. IUS may provide additional insights into transmural disease activity, supporting its integration into treat-to-target strategies."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • CRP

EFFICACY OF RISANKIZUMAB BY CROHN'S DISEASE LOCATION THROUGH 148 WEEKS OF TREATMENT: RESULTS FROM THE SEQUENCE OPEN-LABEL EXTENSION STUDY (UEGW 2026) - P3 | "In Part 1 of the trial, adults with moderately to severely active CD and an inadequate response or intolerance to anti-TNF therapy were randomly assigned to receive RZB or ustekinumab for 48 weeks.1 Patients randomized to RZB continued receiving subcutaneous RZB 360 mg maintenance doses every 8 weeks in Part 2, the open-label extension.2 This post hoc analysis evaluated rates of clinical remission (CD Activity Index [CDAI], average daily stool frequency and daily abdominal pain score [SF/APS]), endoscopic response (Simple Endoscopic Score for CD [SES-CD] >50% decrease), endoscopic remission (SES-CD ≤4), and ulcer-free endoscopy stratified by Part 1 baseline disease location through 148 weeks of treatment. Through 148 weeks of RZB treatment, disease activity measures showed overall improvement or were sustained, regardless of the location of CD. The incremental gain over time in remission rates was most notable for endoscopic outcomes in patients with ileal only..."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

EFFICACY AND SAFETY OF SUBCUTANEOUS RISANKIZUMAB MAINTENANCE THERAPY AMONG PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO RESPONDED TO SUBCUTANEOUS RISANKIZUMAB INDUCTION THERAPY: 24-WEEK RESULTS FROM THE AFFIRM TRIAL (UEGW 2026) - P3 | "In the maintenance period of AFFIRM, the majority (74.4%) of patients with moderately to severely active CD who responded to 12 weeks of SC RZB induction and continued treatment with SC RZB maintenance achieved clinical remission at week 24. RZB-treated patients also achieved endoscopic outcomes through week 24. Safety results of SC RZB maintenance were consistent with the known safety profile of RZB, with no new safety risks identified.4"

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

REAL-WORLD CLINICAL PRACTICE TREATMENT PATTERNS AND PERSISTENCE OF RISANKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE CROHN'S DISEASE: INTERIM RESULTS FROM THE APPRISE STUDY (UEGW 2026) - P | "This interim analysis of the APPRISE study describes real-world RZB persistence and treatment patterns in patients with moderate-to-severe CD. Most pts, irrespective of AT-IR status, received RZB according to label-recommended doses and dosing intervals through month 6, with high persistence observed at 6 months, suggesting favorable real-world treatment persistence."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

SEQUENTIAL IL-23 BLOCKADE IN CROHN'S DISEASE: REAL-WORLD OUTCOMES OF RISANKIZUMAB AFTER USTEKINUMAB FAILURE (UEGW 2026) - "Risankizumab demonstrates significant early clinical and biomarker improvement following Ustekinumab failure in real-world CD patients, supporting sequential IL-23 targeting. Larger prospective studies with endoscopic endpoints are needed to confirm long term efficacy and durability. Disclosure: The authors did not receive any funding for undertaking this study."

Clinical • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • IL12A • IL23A

LEUKOCYTOCLASTIC VASCULITIS FOLLOWING USTEKINUMAB IN A PATIENT WITH CROHN'S DISEASE: A RARE ADVERSE EVENT (UEGW 2026) - "In April 2025 he developed secondary loss of response to infliximab, leading to initiation of adalimumab, which was discontinued shortly thereafter due to suspected prostatic malignancy, later ruled out on biopsy...Therapy for CD was switched to risankizumab without recurrence of vasculitis...Awareness of this entity is essential for prompt recognition and management. Switching to an alternative biologic may be effective and safe."

Adverse events • Clinical • Ankylosing Spondylitis • Benign Prostatic Hyperplasia • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Prostate Cancer • Seronegative Spondyloarthropathies • Spondylarthritis • Vasculitis

THE IMPORTANCE OF DIFFERENTIAL DIAGNOSIS IN ILEAL STRICTURES: B‑CELL INTESTINAL LYMPHOMA IN A RENAL TRANSPLANT RECIPIENT INITIALLY MISDIAGNOSED AS CROHN'S DISEASE (UEGW 2026) - "The patient was referred to our centre and treatment with risankizumab was initiated.After completing oral corticosteroid tapering, she was readmitted with recurrent sub‑occlusion...B‑cell lymphomas may temporarily respond to corticosteroids, explaining initial improvement. This case underscores the need to reassess the diagnosis of Crohn's disease when presentation or evolution is atypical."

Clinical • B Cell Lymphoma • Chronic Kidney Disease • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • High-grade B-cell lymphoma • Immunology • Inflammatory Bowel Disease • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Renal Disease • Transplantation • CD20

AN ANALYSIS OF THE EFFICACY OF RISANKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE CROHN'S DISEASE BY DISEASE DURATION—FINDINGS FROM THE SEQUENCE STUDY (UEGW 2026) - P3 | "Previous studies of risankizumab (RZB), a selective interleukin-23 p19 inhibitor, have demonstrated greater clinical and endoscopic efficacy through 48 wks of treatment compared to ustekinumab (UST). Pts across all BL disease duration subgroups demonstrated durable long-term clinical and endoscopic benefit through 148 wks of RZB treatment. These benefits were highest in the < 2 yr subgroup, supporting early intervention with RZB for pts with CD. For some refractory pts, the efficacy with RZB may take longer to achieve and should be a consideration taken to avoid switching therapies too soon."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • CRP

COMPARATIVE POST-MARKETING SAFETY OF IL-23 PATHWAY INHIBITORS IN INFLAMMATORY BOWEL DISEASE: A DISPROPORTIONALITY ANALYSIS USING THE FAERS DATABASE (UEGW 2026) - "Post-marketing disproportionality profiles differed meaningfully across the studied IL-23 pathway therapies, with ustekinumab showing the largest and most heterogeneous profile, followed by risankizumab, whereas guselkumab and mirikizumab yielded fewer signals overall. Several signals were reproducible across comparator strategies, but many prominent adverse events appeared to reflect treatment delivery, disease severity, or clinical management rather than novel toxic effects. These findings should be interpreted cautiously as hypothesis-generating findings that may guide further pharmacoepidemiologic and clinical investigation."

Clinical • P4 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Liver Failure • Ulcerative Colitis • IL23A