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

PanGen Biotech leverages CHO cell line R&D to drive biopharmaceutical CDMO growth (Korea Biomedical Review) - "Current development efforts are focused on biosimilars for three major blockbuster drugs – BMS’ immunotherapy Yervoy (ipilimumab), Johnson & Johnson Innovative Medicine’s autoimmune treatment Tremfya (guselkumab), and Amgen’s osteoporosis drug Evenity (romosozumab). The company expects to complete the production cell lines for these candidates within the year, positioning itself to meet the growing demand for outsourced biosimilar development."

Commercial • Colorectal Cancer • Crohn's disease • Cutaneous Melanoma • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Inflammatory Bowel Disease • Malignant Pleural Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Osteoporosis • Psoriatic Arthritis • Renal Cell Carcinoma • Ulcerative Colitis

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (clinicaltrials.gov) - P4 | N=10 | Not yet recruiting | Sponsor: University of California, San Francisco

New P4 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Islands of Sparing, Islands of Hope: A Case of Pityriasis Rubra Pilaris Treated with Guselkumab (AAD 2026) - No abstract available

Clinical

Interleukin 12/23 and interleukin 23 inhibitors for moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis. (PubMed, Ann Gastroenterol) - "The randomized controlled trials (RCTs) included evaluated ustekinumab, mirikizumab, risankizumab, and guselkumab. Risankizumab was most effective in induction, while guselkumab was more effective in maintenance. Head-to-head trials are warranted."

Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

Mirikizumab, guselkumab, and risankizumab did not differ in remission efficacy adjusting for imbalanced treatment discontinuation in network meta-analysis of treat-through trials for Crohn’s disease (ECCO-IBD 2026) - "Background Traditional Crohn’s disease (CD) trials used a re-randomisation design, but more recent trials, including trials with the interleukin (IL)-23p19 inhibitors mirikizumab, guselkumab, and risankizumab, used a treat-through design vs a direct comparator ustekinumab; however, there were clinically relevant different trial settings. Consistent results were observed across adjusted approaches compared to the unadjusted NMA. No difference in remission efficacy was observed across mirikizumab, guselkumab, and risankizumab."

Retrospective data • Crohn's disease • Immunology • Inflammatory Bowel Disease

Guselkumab Efficacy and Safety in Moderately to Severely Active Ulcerative Colitis: Real-World Data from a Large Tertiary Center (ECCO-IBD 2026) - "Remission rates with GUS treatment were comparable between ustekinumab (UST)-naïve and UST-exposed patients. In univariate analysis, age, sex, and prior TNF or UST therapy were not associated with steroid-free remission at weeks 8 or 12. Conclusion In this real-world analysis of GUS in moderately to severely active UC, GUS demonstrated marked clinical effectiveness and a favourable safety profile, including in patients previously exposed to UST."

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Differential clinical factors influencing the effectiveness of distinct biologic agents in psoriasis: insights from a prospective cohort study in China. (PubMed, Inflamm Res) - "Predictors of biologic effectiveness differ by agent, supporting personalized treatment based on patient characteristics."

Journal • Dermatology • Genetic Disorders • Immunology • Inflammatory Arthritis • Obesity • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Efficacy of biologic and small-molecule therapies by disease location in moderate-to-severe luminal Crohn’s disease: a systematic review and network meta-analysis (ECCO-IBD 2026) - "Results Twenty RCTs were included evaluating adalimumab (ADA), infliximab (IFX), vedolizumab (VDZ), ustekinumab(UST), mirikizumab (MIRI), risankizumab (RZB), guselkumab (GUS) and upadacitinib (UPA). UST, RZB, GUS and MIRI showed no significant location effect in terms of clinical remission (Figure 1). Figure 1: Efficacy ratios across Crohn’s disease locations Conclusion A location-dependent efficacy gradient was observed with reduced responsiveness in isolated ileal disease and greater efficacy in colonic and ileocolonic involvement, and superiority of specific drug classes in ileal and colonic disease location, emphasizing the importance of considering CD location in treatment algorithms and personalized CD management."

Retrospective data • Review • Crohn's disease • Immunology • Inflammatory Bowel Disease

Impact of concomitant mesalazine administration on the efficacy and safety of advanced therapies in ulcerative colitis: a meta-analysis over the induction and maintenance phases (ECCO-IBD 2026) - "Methods A meta-analysis of RCTs including approved biological agents (Adalimumab,Infliximab,Golimumab,Mirikizumab,Guselkumab,Ozanimod,Etrasimod,Ustekinumab) and small molecules (Tofacitinib,Upadacitinib) in UC patients reporting concomitant msz use was conducted through a search of four databases. Conclusion The concomitant use of msz and advanced therapies is associated with improved mucosal healing during maintenance therapy for UC, suggesting a potential synergistic effect in the long term. Future prospective studies incorporating histologic outcomes are warranted to elucidate the mechanistic contribution of msz in combination regimens."

Metastases • Retrospective data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Safety of dual-targeted therapy in Inflammatory Bowel Disease: a systematic review (ECCO-IBD 2026) - "In total, 230 dual-therapy combinations were reported: tofacitinib/tumor necrosis factor-alpha inhibitor (anti-TNFα), n = 1; tofacitinib/vedolizumab, n = 13, golimumab/guselkumab, n = 71; adalimumab/vedolizumab, n = 55; anti-TNFα/vedolizumab, n = 41; anti-TNFα/anti-interleukin (anti-IL) agent, n = 11; anti-IL/vedolizumab, n = 21; anti-IL/anti-IL, n = 1; other combinations, n = 16. Anti-TNFα combinations demonstrated significantly higher SAEs rates, whereas vedolizumab-based regimens showed fewer infections. Evidence for small-molecule combinations remains limited, highlighting the need for larger prospective research."

Clinical • Review • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy of Guselkumab in Chinese participants with Crohn's Disease following loss of response to Ustekinumab (ChiCTR) - P4 | N=78 | Not yet recruiting | Sponsor: The First Affiliated Hospital,Sun Yat-sen University; The First Affiliated Hospital,Sun Yat-sen University

New P4 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Drug Survival of Biologics in Bionaive and Bioexperienced Patients With Psoriasis. (PubMed, JAMA Dermatol) - "Adalimumab, secukinumab, and ustekinumab among bionaive patients and adalimumab, bimekizumab, brodalumab, guselkumab, ixekizumab, risankizumab, secukinumab, and ustekinumab among bioexperienced patients. In this cohort study in Denmark, among bionaive patients with psoriasis, ustekinumab had superior drug survival compared with adalimumab and secukinumab, and among bioexperienced patients with psoriasis, bimekizumab, guselkumab, and risankizumab had superior drug survival. These results offer insight into the performance of different biologics in the treatment of psoriasis in a routine clinical practice setting."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Extraintestinal manifestations in participants with moderately to severely active Crohn’s disease: Results from the phase 3 GALAXI 2 & 3 studies (ECCO-IBD 2026) - "The phase 3 GALAXI 2 & 3 studies evaluated guselkumab(GUS), a dual-acting IL-23p19 subunit inhibitor, in participants(pts) with moderately to severely active CD...The studies also included ustekinumab(UST), but the current analyses do not include UST...Overall, 14.4%(29/201) of GUS and 17.5%(11/63) of PBO-treated pts with EIMs were receiving prednisone at baseline...Pts receiving GUS also had lower rates of de novo EIMs at Wk12 compared with PBO. These results suggest GUS may improve and prevent EIMs in pts with CD."

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

Infection risk among psoriasis biologic-new users: a cohort study on the French National Health Data System. (PubMed, J Am Acad Dermatol) - "Biologics are associated with low overall infection risks. Among biologics, ustekinumab and IL-23 inhibitors show the lowest overall risk (time to the first inpatient/outpatient event)."

Journal • Dermatology • Immunology • Infectious Disease • Psoriasis • IL23A

CASE SERIES OF COMPLEX PERIANAL FISTULAS WITHOUT LUMINAL CROHN'S DISEASE AT TERTIARY CENTER. (CCCongress 2026) - "One patient received combination therapy with infliximab and azathioprine 150 mg daily and allopurinol 300 mg. One patient was on therapy with guselkumab and upadacitinib (45 mg daily), with promising fistula healing... The cases described present the multimodal importance of perianal Crohn’s involving immunomodulators and surgical intervention in patients without luminal inflammation. This patient cohort includes patients who are currently receiving induction doses of infliximab to an established patient on infliximab 10 mg/kg. Anti-TNF therapy was used as the baseline therapy in our patients."

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

Upadacitinib as a potential option for the management of paradoxical eczema induced by interleukin-23 inhibitors. (PubMed, Dermatol Reports) - "PE has been reported with anti-tumor necrosis factor (TNF)-α, anti-interleukin (IL)-17, and more recently with anti-IL-23 agents such as risankizumab, tildrakizumab, and guselkumab, with an estimated incidence of 1-3% among psoriatic patients treated with biologics, likely underestimated. Herein, we report the successful use of upadacitinib, an oral selective Janus kinase (JAK)-1 inhibitor approved for both psoriatic arthritis and atopic dermatitis, in the management of a PE induced by guselkumab. [...]."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL23A • TNFA

Real-world effectiveness and safety of guselkumab in adult patients with facial and/or genital psoriasis: a 52-week analysis from the Italian multicentric GULLIVER study. (PubMed, J Dermatolog Treat) - "Guselkumab was well-tolerated and no new safety signals were identified. This Italian real-world study demonstrated the high effectiveness and a good safety profile of guselkumab in treating facial and genital psoriasis."

Journal • Real-world evidence • Dermatology • Immunology • Psoriasis

Relative Efficacy of Immunomodulatory Monotherapies for Psoriasis of the Scalp: A Network Meta-Analysis Study. (PubMed, J Cosmet Dermatol) - "We are the first to provide comparative evidence on the efficacy of newly investigated agents such as deucravacitinib, tildrakizumab, roflumilast and icotrokinra. In general, the IL-17 inhibitors (bimekizumab, ixekizumab, secukinumab, brodalumab) and IL-23 inhibitors (icotrokinra, guselkumab, tildrakizumab) were effective depending upon the outcome and time-point being considered. At 16 weeks, for PSSI-100, ixekizumab 150 mg at weeks 0, 2, 4, 8, and 12 ranked highest; at 16 weeks, for Sc-PGA 0/1 bimekizumab 320 mg every 4 weeks ranked highest; at 8 weeks, for PSSI-100 ixekizumab 80 mg every 2 weeks ranked highest; at 8 weeks, for Sc-PGA 0/1 secukinumab 300 mg at weeks 1, 2, 3 and then every 4 weeks ranked highest. Small-molecule therapies (apremilast, deucravacitinib, roflumilast) improved scalp psoriasis modestly. Our work would guide the design of future studies and clinical decision-making."

Clinical • Journal • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A • IL23A

S3 Guideline for the Treatment of Psoriasis vulgaris, adapted from EuroGuiDerm - part 2: Specific clinical and comorbid situations. (PubMed, J Dtsch Dermatol Ges) - "In the chapter on inflammatory bowel diseases, risankizumab and guselkumab have been added as recommended treatment options, as both agents have recently been approved for the indications Crohn's disease and ulcerative colitis. Further substantial revisions are included in the chapters on patients with a history of malignancy and viral hepatitis."

Clinical guideline • Journal • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Oncology • Psoriasis • Pulmonary Disease • Respiratory Diseases • Tuberculosis • Ulcerative Colitis

APEX: A Study of Guselkumab in Participants With Active Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=1054 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: May 2028 ➔ Oct 2027

Trial completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP

The Drug Update: Recent drug approvals, winter 2026 edition. (PubMed, Nurse Pract) - "This article highlights the following new medications and vaccinations: suzetrigine (Journavx); gepotidacin (Blujepa); meningococcal groups A, B, C, W, and Y vaccine (Penmenvy); clesrovimab-cfor (Enflonsia); and acoltremon (Tryptyr). Additionally, this article highlights the recent approval of moderately to severely active Crohn's disease as a new indication for guselkumab (Tremfya)."

Journal • CNS Disorders • Crohn's disease • Dry Eye Disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Meningococcal Infections • Nephrology • Ophthalmology • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

IL-23p19-inhibitor pharmacokinetics across immune-mediated inflammatory diseases: insights from a systematic review (ECCO-IBD 2026) - "Results A total of 21 studies were identified of which nine focused on risankizumab, three on tildrakizumab, six on guselkumab and three on mirikizumab. 2 ). These findings highlight the need for further research to better define PK parameters and influencing covariates, enabling personalized dosing strategies for IL-23p19 inhibitors in IBD."

PK/PD data • Review • Crohn's disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Effect of IL-23 inhibitors on extra-intestinal manifestations and concurrent immune-mediated inflammatory diseases in patients with inflammatory bowel disease (ECCO-IBD 2026) - "Methods This multicentric retrospective cohort included adult patients with ulcerative colitis (UC) or Crohn’s disease (CD) who initiated an IL-23 inhibitor (risankizumab, mirikizumab or guselkumab) for IBD and had at least one EIM or IMID at baseline. New-onset EIMs/IMIDs were uncommon. Interpretation of these outcomes remains limited due to small subgroup sizes, and further studies are needed to better define the role of IL-23 inhibition in IBD patients with coexisting IMIDs."

Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

Optimizing Ulcerative Colitis maintenance treatment: Indirect comparison on number needed to treat among interleukin-23p19 inhibitors highlights mirikizumab’s efficacy (ECCO-IBD 2026) - P2/3, P3 | "Background We indirectly compared the interleukin-23p19 inhibitors (IL-23p19i) mirikizumab (MIRI), risankizumab (RIS), and guselkumab (GUS) in adults with ulcerative colitis (UC) by estimating the number of patients needed to treat (NNT), 1 versus placebo (PBO), for 1 additional patient to benefit after approximately (approx.) 1 year of maintenance treatment. NNTs for MIRI and GUS were similar, suggesting comparable efficacy. Though further studies are needed to confirm these findings, they provide valuable evidence to support the efficacy of MIRI across clinical endpoints for UC and to inform IL-23p19i selection in practice."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CREM

Pregnancy outcomes in maternal exposure to guselkumab: Review of cases reported to the Company Global Safety Database (ECCO-IBD 2026) - "3,4 Conclusion These findings suggest no apparent impact of GUS on pregnancy outcomes; however, they should be interpreted cautiously given data limitations. Further studies are warranted to confirm these observations and to better characterize the safety profile of GUS exposure during pregnancy."

Case report • Clinical • Review • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A