Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J - LARVOL DELTA

Risk of lymphoma with antimetabolite and biologic combinations: A pharmacovigilance analysis using the FDA adverse event reporting system database (ASH 2025) - "Our study compared combinations of antimetabolites—such asmethotrexate (MTX), mercaptopurine (6-MP), and azathioprine (AZA)—with anti-TNF agents includinginfliximab, adalimumab, certolizumab, and golimumab, to determine which regimens were most stronglyassociated with lymphoma. Clinicians should carefully weigh the risks and benefits of combination immunosuppressivetherapy, especially when prescribing infliximab with MTX or 6-MP, given the observed synergistic increasein risk for lymphoma."

Adverse events • Hematological Malignancies • Immunology • Lymphoma • ROR1

Simponi - opinion on variation to marketing authorisation (European Medicines Agency) - "On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Simponi...The CHMP adopted a new indication as follows: Paediatric ulcerative colitis (pUC)...Rheumatoid arthritis (RA)...Polyarticular juvenile idiopathic arthritis (pJIA)...Psoriatic arthritis (PsA)...Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy....Non‑radiographic axial spondyloarthritis (nr‑Axial SpA)."

CHMP • Ankylosing Spondylitis • Idiopathic Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Safety profile of TNF- alpha Inhibitors in pediatric patients: A post-marketing surveillance study based on the FAERS database. (PubMed, PLoS One) - "This study systematically evaluated the safety profile of tumor necrosis factor-alpha (TNF-α) inhibitors in pediatric patients using data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2024.Through disproportionality analysis of adverse event (AE) reports for infliximab, etanercept, adalimumab, golimumab and certolizumab, we identified 852 significant safety signals spanning 27 system organ classes (SOCs). While these agents remain vital for managing chronic inflammatory diseases, the findings advocate for enhanced clinical vigilance. We propose a tiered monitoring protocol prioritizing infection surveillance (e.g., serial inflammatory markers), systematic injection-site evaluations, and longitudinal organ function assessments, particularly during the initial treatment phase, to optimize therapeutic risk-benefit ratios."

Journal • P4 data • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Oncology • Pediatrics

Serious Infections in Offspring Exposed to Tumour Necrosis Factor Inhibitors During Pregnancy: Comparison of Timing During Pregnancy and Placental Transfer Ability. (PubMed, Arthritis Rheumatol) - "Overall, TNFi exposure was not associated with serious infections; exploratory signals by timing and placental transfer were imprecise and require confirmation."

Journal • Infectious Disease • Oncology

Rate and predictors of successful antitumor necrosis factor deescalation after dose intensification in inflammatory bowel disease patients: a real-world Greek-Turkish collaborative study. (PubMed, Eur J Gastroenterol Hepatol) - "One quarter of IBD patients requiring intensified anti-TNFa therapie were successfully deescalated to standard dosing, after a median of 16.0 (IQR: 8.0-36.0) months."

Journal • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • TNFA

An evaluation of guselkumab for the treatment of ulcerative colitis. (PubMed, Expert Opin Biol Ther) - "No direct comparisons are available between individual IL-23 antagonists or with ustekinumab, the IL-12/23 antagonist, which limits decision-making in clinical practice. Combining two biologics as advanced combination treatment is an attractive strategy to break the therapeutic efficacy ceiling in UC - a proof-of-concept phase 2 trial combining guselkumab and golimumab has shown promise, the combination is currently undergoing evaluation in a larger ongoing trial."

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

Recurrent Pericarditis in a Patient With Ankylosing Spondylitis: A Report of a Rare Case. (PubMed, Cureus) - "We report a 31-year-old human leukocyte antigen B27 (HLA-B27)-positive man with AS diagnosed in 2018 who, after discontinuing golimumab in 2021, experienced two episodes of acute pericarditis in 2025...He improved with colchicine and a corticosteroid taper...Taken together, the relapse and overall context favored attribution to AS-related inflammation. This case underscores the need to keep pericarditis in mind when patients with AS present with chest pain and to align pericarditis therapy with control of the underlying disease."

Journal • Ankylosing Spondylitis • Cardiovascular • CNS Disorders • Cytomegalovirus Infection • Depression • Epstein-Barr Virus Infections • Hepatitis B • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Pain • Psychiatry • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies

TNF Inhibitor-Induced Sarcoidosis-Like Lesions in Inflammatory Bowel Disease. (PubMed, United European Gastroenterol J) - "TNF inhibitor-induced sarcoidosis should be considered in inflammatory bowel disease patients with chronic respiratory symptoms or fever after exclusion of mycobacterial infection. Management involves discontinuation of TNF inhibitors and a course of steroids."

Journal • CNS Disorders • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Oncology • Pulmonary Disease • Sarcoidosis • Ulcerative Colitis

Lucentis Plus Tagolimumab in PD-L1+, HR+/HER2- Advanced Breast Cancer After CDK4/6 Inhibitors (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1

Complement system activation is associated with spinal radiographic progression in axial spondyloarthritis after 2 years of follow-up: findings from the CONSUL RCT. (PubMed, RMD Open) - "Complement activation marker C3dg, MASP-1 and MASP-3 levels before TNFi therapy predicted new bone formation after 2 years of follow-up among axSpA patients with a high risk of radiographic progression. Furthermore, levels of L-ficolin and C3dg at follow-up were elevated in axSpA patients with new bone formation. Our findings support an association between activation of the complement system and radiographic spinal progression in patients with axSpA."

Biomarker • Clinical • Journal • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Lumbar Back Pain • Musculoskeletal Pain • Oncology • Pain • Seronegative Spondyloarthropathies • Spondylarthritis

Impact of Biologic Class on Ocular Outcomes in Psoriasis: Insights from a Multi-Institutional Database Study (ISDS 2025) - "Adults aged 18–89 years with psoriasis who initiated either TNFα inhibitors (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab) or IL-17 inhibitors (secukinumab, ixekizumab, brodalumab, bimekizumab) within one year of diagnosis were identified. In this large, multi-institutional analysis, psoriasis patients treated with TNFα inhibitors experienced higher rates of several ocular inflammatory and degenerative conditions compared to those treated with IL-17 inhibitors. These findings highlight the importance of considering ocular comorbidity risk when selecting biologic therapy for psoriasis."

Clinical • Cataract • Conjunctivitis • Dermatology • Dry Eye Disease • Immunology • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Psoriasis • Uveitis • IL17A

EFFECT-1LAT: Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population (clinicaltrials.gov) - P=N/A | N=4000 | Not yet recruiting | Sponsor: Pfizer | Trial completion date: Oct 2025 ➔ Mar 2026 | Initiation date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Global burden of TNF-α inhibitors associated demyelinating diseases: A global disproportionality analysis. (PubMed, Medicine (Baltimore)) - "Five TNF-α inhibitors (infliximab, adalimumab, etanercept, certolizumab pegol, and golimumab) were included in this study. Clinicians should remain vigilant for neurological symptoms in patients receiving these therapies. Although this disproportionality analysis did not permit causal interpretation, it is important to recognize that the therapeutic benefits of TNF-α inhibitors in managing inflammatory and autoimmune diseases may still outweigh these potential risks."

Journal • Observational data • CNS Disorders • Immunology • Multiple Sclerosis • Oncology

Case Reports: Peficitinib Efficacy in Treating Palmoplantar Pustulosis Induced by Paradoxical Reactions to Golimumab in Two Rheumatoid Arthritis Cases. (PubMed, Mod Rheumatol Case Rep) - "These findings suggest that peficitinib could serve as an effective alternative when tumour necrosis factor inhibitors are no longer viable. Thus, peficitinib may be a potential therapeutic option for the management of rheumatoid arthritis patients with palmoplantar pustulosis."

Journal • Dermatitis • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Rheumatoid Arthritis • Rheumatology

Cost-Effectiveness Analysis of Etrasimod Compared With Biologic Therapies for the Treatment of Patients with Moderately-to-Severely Active Ulcerative Colitis in Spain. (PubMed, Pharmacoecon Open) - "In AT-naïve and AT-experienced patients, etrasimod is a dominant therapy (cost savings, greater effectiveness) compared with commonly used ATs."

HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Drug persistence of first- and advanced-line therapy for chronic inflammatory pouch disorders: A prospective cohort spanning sequential treatment lines. (PubMed, Dig Liver Dis) - "In inflammatory pouch disorders, biologic/small-molecule persistence falls steeply after first-line failure, underscoring the importance of early drug selection and avoidance of recycled pre-IPAA agents. Ustekinumab shows superior persistence both as first- and second-line therapy."

Journal • Gastrointestinal Disorder • Inflammation

Systematic Review and Meta-Analysis of the Efficacy and Safety of Biologics in the Treatment of Ankylosing Spondylitis (ISPOR-EU 2025) - "Full data on study characteristics and outcomes related to the efficacy and safety of biologics in AS treatment were extracted. A total of 544 records were initially identified, of which 26 studies were included: 17 studies on TNF-α-inhibitors (etanercept, infliximab, adalimumab, golimumab, certolizumab), 5 studies on IL-17-inhibitors (secukinumab, ixekizumab), and 4 studies on JAK-inhibitors (tofacitinib, upadacitinib). Biologics demonstrated significantly greater clinical efficacy compared to placebo in the treatment of AS, with consistent improvements in BASDAI, ASAS20, and ASAS40. While mortality and SAEs rates were similar across groups which had no significant differences compared to placebo, AEs risks varied by biologic class, being no significant different for JAK-inhibitors and increased for TNF-α and IL-17-inhibitors."

Retrospective data • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Risk of pulmonary fungal infections associated with biologics: a FAERS database disproportionality analysis. (PubMed, Front Immunol) - "Among them, the highest reporting odds ratio (ROR) were observed for infliximab(ROR = 26.02, 95% CI 17.72-38.21), rituximab(ROR = 16.23, 95% CI 13.06-20.18), tocilizumab(ROR = 14.45, 95% CI 12.28-17.00), and baricitinib(ROR = 11.01, 95% CI 7.77-15.59). Other biologics associated with a disproportionality signal in PFI risk included golimumab(ROR = 6.73, 95% CI 2.15-21.13), upadacitinib(ROR = 4.61, 95% CI 2.61-8.14), ustekinumab(ROR = 4.58, 95% CI 1.46-14.36), adalimumab(ROR = 3.45, 95% CI 2.08-5.72), tofacitinib(ROR = 3.18, 95% CI 2.04-4.95), abatacept(ROR = 3.16, 95% CI 1.74-5.73), etanercept(ROR = 2.58, 95% CI 2.06-3.24), certolizumab pegol(ROR = 1.64, 95% CI 1.27-2.10). The signal for secukinumab was not statistically (ROR = 1.70, 95% CI 0.55-5.32)...Our findings suggest that concomitant use of biologics is associated with a stronger disproportionality signal for PFI. The inherent limitations and potential reporting biases of the FAERS database necessitate..."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study. (PubMed, BioDrugs) - P1 | "Following single-dose administration, the study supported a demonstration of PK similarity between AVT05 and EU-RP and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms."

Journal • PK/PD data

"Parenchymal CLL Infiltration without Richter Transformation: A case report." (DGHO 2025) - "His RA treatment was altered 15 days before from adalimumab to golimumab due to local skin reaction...Under the assumption the optic neuritis was triggered by Golimumab or RA he received 2 infusions of rituximab 375 mg/m2...Central pathology finally revealed an "aggressive" CLL variant with lack of RT and he was treated with Zanubrutinib resulting in partial remission. CNS involvement in CLL is rare and poses a diagnostic and therapeutic challenge. Our case underlines the importance in discrimination between RT and CLL for optimal treatment, as well as the significance of brain biopsy in case of elusive findings.The highly atypical presentation of parenchymal brain infiltration could be associated with the underlying rheumatologic disease and exposure to chronic inflammation and immunosuppression.While BTK inhibitors like zanubrutinib have shown promise in CNS lymphomas, further data are needed to assess durability and long-term outcomes in CLL-related CNS..."

Case report • Clinical • Chronic Lymphocytic Leukemia • CNS Disorders • CNS Lymphoma • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Leukemia • Lymphoma • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rheumatoid Arthritis • Rheumatology • Richter's Syndrome • IGH • TP53

Evaluation of anti-drug antibodies against therapeutic monoclonal antibodies and related product in Japanese patients with rheumatoid arthritis and their clinical impact. (PubMed, Eur J Pharm Sci) - "Here, we measured ADA levels in the sera of Japanese patients with RA treated with biopharmaceuticals (infliximab, adalimumab, golimumab, tocilizumab, and etanercept), investigated the clinical factors associated with ADA formation, and examined the effect of ADA on the pharmacological activity of each drug...Among clinical factors, the use of concomitant methotrexate influenced ADA prevalence in patients treated with adalimumab and the route of administration was a significant factor in patients treated with tocilizumab...The free drug concentration tended to be lower in ADA-positive samples, suggesting that the presence of ADA may have pharmacokinetic implications. Although experimental evaluation of the impact of ADA on drug pharmacological activity in patient samples is typically complex, we developed a method to measure residual drug bioactivity using cell-based assays as an alternative to evaluating the neutralization activity of ADA, and demonstrated the utility..."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • HLA-DRB1

The Cost of Control: A Case of Pneumocystis Pneumonia While on Upadacitinib for Crohn's Disease (ACG 2025) - "He previously had an inadequate response to infliximab, ustekinumab and adalimumab...He was started on Bactrim with symptomatic response and discharged. His UPA was discontinued and he was transitioned to golimumab with continued PJP prophylaxis. Prior studies have shown that the risk of PJP in IBD is low...Pneumocystis jirovecii Pneumonia Complicating Use of Upadacitinib in a Patient With Ulcerative Colitis and Primary Sclerosing Cholangitis: A Case Report. Epub 2024 Apr 24."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Pneumonia • Respiratory Diseases • Rheumatology • Ulcerative Colitis

Efficacy of Advanced Therapies for Naïve and Experienced Patients for Moderately-to-Severely Active Ulcerative Colitis: A Bayesian Network Meta-Analysis (ACG 2025) - "ADA, adalimumab; CrI, credible interval; ETS, etrasimod; FIL, filgotinib; GOL, golimumab; GUS, guselkumab; IFX, infliximab; MIR, mirikizumab; OZN, ozanimod; PBO, placebo; RR, relative risk; RZB, risankizumab; TOF, tofacitinib; UPA, upadacitinib; UST, ustekinumab; VDZ, vedolizumab. Four additional studies each for induction and maintenance were included. Results of pairwise comparisons across agents from the 2022 NMA were consistent. For additional agents, most pairwise comparisons had no significant difference at the end of induction and maintenance (Figs 1 & 2).For AT-N induction clinical remission, MIR 300mg was significantly less effective vs RZB 1200mg (RR, 0.7; 95% CrI, 0.5-1.0) and GUS 200mg was favored vs MIR 300mg (1.6, 1.1-1.2)."

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

Demographics and Clinical Characteristics of Patients With Ulcerative Colitis Receiving First-Line Advanced Therapies Categorized in AGA Guidelines as Lower, Intermediate, and Higher Efficacy (ACG 2025) - "Patients were categorized into the higher (etrasimod, infliximab, ozanimod, upadacitinib, and vedolizumab), intermediate (golimumab, mirikizumab, tofacitinib, and ustekinumab), and lower (adalimumab) efficacy groups. In total, 3,833 and 2,719 patients were included from the IQVIA and Optum databases, respectively, with a substantial proportion of patients in the lower efficacy group (lower: 34.9% and 23.8%; intermediate: 8.8% and 12.3%; higher: 56.4% and 64.0%; Figure 1). Within the higher efficacy group in IQVIA and Optum databases, respectively, 59.5% and 61.7% received vedolizumab, 39.7% and 34.8% received infliximab, and < 1% and 3.5% received other treatments. Age was significantly associated with higher vs."

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

Trends in Out-of-Pocket Spending for Drugs Under Medicare Part D in Moderate to Severe Inflammatory Bowel Disease and the Impact of the Inflation Reduction Act (ACG 2025) - "Eight available IBD drugs were included: adalimumab, tofacitinib, upadacitinib, ustekinumab, risankizumab, guselkumab, certolizumab and golimumab. Between 2019 and 2024, median annual OOP costs for most agents ranged from $4,000 to $13,000. In 2025, OOP costs dropped sharply to the $2,000 cap or below for all agents, while retail prices remained stable or slightly increased. Interrupted time series analysis demonstrated a significant policy-driven decline in OOP spending after 2025 across most drugs (excluding adalimumab and risankinumab due to insufficient data) with absolute reductions ranging from $3,283–$10,922 (p< 0.05) Implementation of the IRA's $2,000 OOP cap in 2025 was associated with a marked and immediate reduction in financial burden for high-cost IBD therapies."

Medicare • Reimbursement • US reimbursement • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease