Tremfya (guselkumab) / J&J, Otsuka, Novartis - LARVOL DELTA

Real-world efficacy and retention of guselkumab in psoriatic arthritis: insights from a 12-month multicenter study. (PubMed, ARP Rheumatol) - "Guselkumab demonstrated significant efficacy in reducing disease activity and a favorable retention rate over 12 months in a real-world PsA cohort. These findings support guselkumab as an effective treatment for PsA, although further prospective studies are needed to confirm long-term safety and efficacy."

Clinical • Journal • Real-world evidence • Retrospective data • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A

Guselkumab In A Subset Of Multifailure Patients With Hidradenitis Suppurativa: Real-Word Evidence from Federico II. (PubMed, Clin Cosmet Investig Dermatol) - "Although limited by a small sample size, this study contributes to the growing real-world evidence supporting guselkumab as a potential treatment option in multi-refractory HS. Larger, placebo-controlled trials are needed to further define its role in treatment algorithms."

Journal • Dermatology • Hidradenitis Suppurativa • Immunology • Pain • Psoriasis • IL17A • IL23A

U.S. FDA approves TREMFYA (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor (Yahoo Finance) - "The plaque PsO approval was based on results from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and supportive data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO."

FDA approval • Psoriasis • Psoriatic Arthritis

Evaluating Biologic Effectiveness in Co-Occurring Dermatologic and Rheumatic Disease: A Systematic Review (ACR Convergence 2025) - "Biologics included: adalimumab, secukinumab, etanercept, infliximab, ustekinumab, ixekizumab, guselkumab, risankizumab, apremilast, baricitinib, ruxolitinib, brodalumab, dupilumab, and belimumab. This review highlights the expanding role of biologics in the treatment of rheumatologic conditions beyond their primary dermatologic indications. Their interdisciplinary applications present new opportunities for research and clinical practice, underscoring the need for further investigation to optimize their use and broaden their therapeutic scope."

Review • Ankylosing Spondylitis • Dermatology • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Systemic Lupus Erythematosus • IL17A • IL23A

Shared Immunopathologic and Biologic Targets in Comorbid Dermatologic and Gastrointestinal Disease (EADV 2025) - "Biologics included: adalimumab, secukinumab, etanercept, infliximab, ustekinumab, ixekizumab, guselkumab, risankizumab, apremilast, baricitinib, ruxolitinib, brodalumab, dupilumab, and belimumab. This review highlights the expanding role of biologics in the treatment of gastrointestinal conditions beyond their primary dermatologic indications. Their interdisciplinary applications present new opportunities for research and clinical practice, underscoring the need for further investigation to optimize their use and broaden their therapeutic scope."

Atopic Dermatitis • Crohn's disease • Dermatitis • Dermatology • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Hepatitis C • Hepatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Psoriasis • Rheumatology • Ulcerative Colitis

Recalcitrant palmoplantar pustulosis successfully controlled with Lebrikizumab (EADV 2025) - "Previous treatments included fumaric acid, PUVA, methotrexate, Tildrakizumab, Risankizumab, Upadacitinib, Guselkumab, Bimekizumab, Ixekizumab, Baricitinib and Apremilast...When we first saw the patient in October 2024, he was receiving Guselkumab and Deucravacitinib, alongside systemic steroids (methylprednisolone, 40 mg/day) and various analgesics, including tramadol, to manage the painful palmoplantar lesions... To the best of our knowledge, this report is the first case of successful treatment of PPP with Lebrikizumab in the literature. It offers clinicians another treatment option for this challenging disease and adds to the literature linking PPP to Th2 inflammation."

Dermatology • Dermatopathology • Immunology • Inflammation • Psoriasis • IL13

COMPARISON OF PHARMACODYNAMIC SERUM IL-22 AND MECHANISTIC TISSUE MOLECULAR CHANGES BETWEEN GUSELKUMAB SUBCUTANEOUS AND INTRAVENOUS INDUCTION DOSING IN MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE: POST-HOC ANALYSIS OF THE GRAVITI AND GALAXI PHASE 3 STUDIES (UEGW 2025) - "GUS reduced serum levels of IL-22 protein at WK12 relative to baseline with both SC and IV induction. Following GUS SC induction, transcriptional changes observed at WK12 in GRAVITI were highly correlated with those observed with GUS IV induction from GALAXI Ph3 in ileum and rectum segments. GUS SC and IV induction regimens demonstrate similar molecular effects."

P3 data • PK/PD data • Retrospective data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IFNG • IL17A • IL22 • IL23A

IMPACT OF SUBCUTANEOUS GUSELKUMAB INDUCTION THERAPY ON MOLECULAR INFLAMMATION IN PATIENTS WITH ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3 ASTRO STUDY (UEGW 2025) - "Mechanistic observations confirm that GUS SC and GUS IV induction treatment show significant correlation, supporting the efficacy of both routes of administration in UC. Results from molecular analysis of the ASTRO study corroborate efficacy results observed for GUS SC induction in UC. These data demonstrate that GUS SC induction reduced inflammatory biology towards a normal state while upregulating genes associated with healthy epithelium in patients who achieved clinical remission or HEMI at WK12."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IFNG • IL22 • IL23A

JAK INHIBITORS EXHIBIT SUPERIOR CLINICAL EFFICACY COMPARED TO ANTI-IL-23 BIOLOGICS IN REFRACTORY ULCERATIVE COLITIS (UEGW 2025) - "Vedolizumab has also demonstrated effectiveness when introduced early in the disease course with a greater 52-week treatment persistence and reduced hospitalisation rates compared to anti-TNFα agents as second-line therapy (2)...Notably, Guselkumab is not yet approved for UC treatment in the UK...Within the anti-IL-23 group, 5 patients received Mirikizumab and 8 Ustekinumab; Risankizumab was not used in this cohort. In the JAK group, 3 patients were treated with Upadacitinib, 4 with Filgotinib, and 4 with Tofacitinib...Subtotal colectomy was performed in one patient in the Mirikizumab group following completion of induction therapy, and in two additional patients within three months of initiating the same agent (Table 1).BiologicPatients (N)Colectomy(N)Drug persistenceMirikizumab533/5Ustekinumab815/8Upadacitinib303/3Filgotinib403/4Tofacitinib404/4Table 1... JAK inhibitors showed an improvement in SCCAI at 6 months compared to anti-IL-23 agents. No significant differences..."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP • IL23A

COMPARATIVE EFFICACY OF GUSELKUMAB VS. RISANKIZUMAB IN INDUCTION PHASE FOR MODERATE TO SEVERE CROHN'S DISEASE: AN ANCHORED MAIC ANALYSIS (UEGW 2025) - "The anchored MAIC analysis demonstrates comparable to even superior efficacy of guselkumab over risankizumab in inducing symptomatic improvements in Crohn's disease patients. It also suggests that subcutaneous induction seems to be preferential over iv induction."

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

EFFICACY OF GUSELKUMAB IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS BY EXTENT OF DISEASE AND INFLAMMATORY BURDEN: SUBGROUP ANALYSIS OF THE PHASE 3 QUASAR MAINTENANCE STUDY (UEGW 2025) - P2/3 | "For pts with moderately to severely active UC with extensive disease or high inflammatory burden, greater efficacy rates were observed with GUS 200mg SC q4w compared with GUS 100mg SC q8w."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Ulcerative Colitis • CRP • IL23A

EARLIER USE OF GUSELKUMAB IS PROJECTED TO YIELD LONG-TERM SUSTAINED REMISSION IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS (UEGW 2025) - "Model projections suggest that using guselkumab in first line is associated with long-term sustained remission for patients with UC, compared to using guselkumab in later lines of treatment."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

MAINTENANCE OF ENDOSCOPIC AND HISTOLOGIC EFFICACY WITH GUSELKUMAB FOR ULCERATIVE COLITIS AT WEEK 92 OF THE QUASAR LONG-TERM EXTENSION STUDY (UEGW 2025) - "High rates of long-term sustained endoscopic and histologic endpoints were observed at W92 of the LTE with both GUS dose regimens."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

EFFICACY AND SAFETY OF SUBCUTANEOUS GUSELKUMAB INDUCTION AND MAINTENANCE THERAPY IN PARTICIPANTS WITH ULCERATIVE COLITIS: RESULTS THROUGH WEEK 48 FROM THE PHASE 3 ASTRO STUDY (UEGW 2025) - "Pts also had documented inadequate response/intolerance to biologics, Janus kinase (JAK) inhibitors, and/or sphingosine-1-phosphate (S1P) inhibitors (BIO/JAKi/S1Pi-IR) or to corticosteroids, 6-mercaptopurine, or azathioprine. GUS SC induction followed by SC maintenance was efficacious through 1 year in pts with moderately to severely active UC, and the safety profile is consistent with GUS in its approved indications including UC."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Respiratory Diseases • Ulcerative Colitis

EFFECT OF GUSELKUMAB SUBCUTANEOUS INDUCTION AND MAINTENANCE ON BOWEL URGENCY AND ABDOMINAL PAIN AS MEASURED BY THE UC-PRO/SS IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3 ASTRO STUDY (UEGW 2025) - "Pts had a documented inadequate response/intolerance to biologics, Janus kinase (JAK) inhibitors, and/or sphingosine-1-phosphate (S1P) inhibitors (BIO/JAKi/S1Pi-IR) or to corticosteroids, 6-mercaptopurine, or azathioprine. Pts with moderately to severely active UC treated with GUS SC experienced CMI at W12 and W24 in UC signs and symptoms as measured by UC-PRO/SS compared with PBO."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Pain • Ulcerative Colitis

BENEFIT-RISK OF GUSELKUMAB COMPARED TO PLACEBO IN THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UEGW 2025) - "These findings support a favorable benefit-risk profile for guselkumab induction (200 mg IV q4w or 400mg SC q4w) and maintenance (200 mg SC q4w or 100 mg SC q8w) treatment in participants with moderately to severely active UC. The favorable benefit-risk profile was consistently demonstrated across the populations studied, including ADT-naïve and ADT-IR participants."

Clinical • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Ulcerative Colitis

INTRAVENOUS AND SUBCUTANEOUS GUSELKUMAB INDUCTION THERAPY ARE BOTH EFFICACIOUS IN CROHN'S DISEASE PATIENTS WITH HIGH BASELINE DISEASE SEVERITY: RESULTS AT WEEK 12 FROM THE PHASE 3 GALAXI AND GRAVITI STUDIES (UEGW 2025) - "Both IV and SC induction with GUS were similarly effective in pts with moderately to severely active CD across predefined subgroups of disease location and baseline clinical, endoscopic, and inflammatory biomarker disease activity. The treatment effects were consistent in the subgroups following IV and SC induction, particularly in those that represent high disease severity."

Clinical • P3 data • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • CRP

EFFICACY OF GUSELKUMAB FOR SMALL BOWEL LESIONS USING BALLOON ASSISTED ENTEROSCOPY: A PHASE 3, OPEN-LABEL, MULTICENTER STUDY (UEGW 2025) - "Overall, this study showed that GUS is well-tolerated and effective for treating patients with moderately to severely active CD, and the results also suggested the effectiveness of GUS in small bowel lesions."

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

GUSELKUMAB MAINTENANCE DOSE REGIMENS IN PATIENTS WITH HIGH DISEASE ACTIVITY AND SEVERITY: SUBGROUP ANALYSIS OF PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE IN THE GALAXI PHASE 3 STUDIES (UEGW 2025) - "The studies also included placebo and ustekinumab arms, but this analysis focused on differences between GUS maintenance doses. Pts with high clinical or endoscopic disease severity at baseline, greater inflammatory burden after induction, or who had not achieved endoscopic response after induction showed greater clinical and endoscopic outcomes at Wk 48 with GUS 200mg SC q4w compared with 100mg SC q8w."

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

GUSELKUMAB PHARMACOKINETICS AND EXPOSURE-RESPONSE RELATIONSHIPS ARE CONSISTENT FOLLOWING INTRAVENOUS VERSUS SUBCUTANEOUS INDUCTION IN PARTICIPANTS WITH CROHN'S DISEASE (UEGW 2025) - "Average serum GUS concentrations and E-R relationships were similar after IV vs SC induction and had no impact on safety, supporting the use of either administration route and induction dose regimen in CD patients."

PK/PD data • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease

ENDOSCOPIC PATIENT CLUSTERING TO INVESTIGATE DIFFERENTIAL TREATMENT EFFECTS OF GUSELKUMAB AND USTEKINUMAB IN CROHN'S DISEASE: POST-HOC ANALYSIS OF GALAXI AND GRAVITI TRIALS (UEGW 2025) - "Endoscopic patient clustering provides higher resolution of CD subtypes to delineate differential treatment effects. GUS demonstrated endoscopic efficacy across all patients at WK12, where UST showed placebo-like efficacy in 38% of patients, supporting superior endoscopic efficacy over UST across all patients by WK48. Reductions in narrowing with GUS proposes a role of GUS in affecting stricture biology in addition to broader segment-specific molecular treatment effects that will be explored in future research."

Clinical • Retrospective data • Colon Cancer • Colorectal Cancer • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

EFFECTS OF SUBCUTANEOUS GUSELKUMAB INDUCTION AND MAINTENANCE ON HISTOLOGIC OUTCOMES IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE IN GRAVITI, A PHASE 3 DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY (UEGW 2025) - "Compared to PBO, pts with moderately to severely active CD receiving SC induction and maintenance treatment with GUS achieved greater rates of histologic response, histologic remission, histo-endoscopic response, and histo-endoscopic remission through W48. These results support the use of histologic and composite histologic and endoscopic endpoints as a measure of CD activity, and the efficacy of SC guselkumab in CD."

Clinical • P3 data • Colorectal Cancer • Crohn's disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease

MOLECULAR DIFFERENTIATION OF GUSELKUMAB AND USTEKINUMAB IN MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE: POST HOC ANALYSIS OF THE GALAXI 2 AND 3 PHASE 3 STUDIES (UEGW 2025) - "GUS decreased IL-23-dependent serum proteins and improved tissue transcriptional profiles in pts with isolated ileal disease while UST only reduced serum IFNγ and had a minimal impact on IL-23-dependent transcriptional modules. These data suggest potential differences in IL-23 and IL-12 pathway enrichment in isolated ileal disease where inhibition of IL-23p19 subunit with GUS achieved greater molecular treatment effects early which were maintained through WK48 and associated with differential clinical outcomes in patients with isolated ileal disease."

P3 data • Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • IFNG • IL12A • IL17A • IL22 • IL23A

DEVELOPMENT AND CHARACTERIZATION OF SIM0709, A NOVEL HALF-LIFE EXTENDED BI-SPECIFIC ANTIBODY SIMULTANEOUSLY TARGETING TL1A AND IL-23P19 FOR THE TREATMENT OF IBD AND BEYOND (UEGW 2025) - " SIM0709 simultaneously bound to both TL1A and IL-23 proteins with sub-nanomolar affinity and demonstrated superior functional activities under various functional assays on both TL1A and IL-23 axes compared to that of benchmark anti-TL1A mAb RG6631 and Guselkumab or its combination, respectively. Taken together, these data support the further development of SIM0709 as a potential FIC and BIC therapeutic agent for the treatment of IBD with expected first-in-human study in H1 2026."

Inflammatory Bowel Disease • CD4 • IFNG • IL12A • IL17A • IL18 • IL23A • IL2RA

EFFICACY AND SAFETY OF SUBCUTANEOUS GUSELKUMAB RESCUE THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE AND INADEQUATE RESPONSE TO USTEKINUMAB: RESULTS FROM GALAXI 1, 2, & 3 LONG-TERM EXTENSION (UEGW 2025) - "Among pts who experienced inadequate response to UST in the LTE, more than half achieved clinical remission 16 weeks after treatment switch to GUS 200 mg SC q4w, and approximately 50% were in endoscopic response ~1 year after treatment switch. These data suggest pts with an inadequate treatment response to UST may benefit from GUS treatment. Results should be interpreted considering that pts received GUS SC maintenance therapy directly without IV induction."

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