Cimzia (certolizumab pegol) / Astellas, UCB, Ferring - 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

P115 Long-term outcomes of biologic-naive and biologic-experienced patients, with a focus on women of childbearing age with chronic plaque psoriasis treated with certolizumab pegol. (PubMed, Br J Dermatol) - "CZP was also reported to have good effectiveness on skin and patient-reported quality-of-life scores. Drug survival was high at 12 months across all subgroups, consistently with other TNFis."

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

O07 Serious infection risk with systemic treatments for psoriasis: a cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). (PubMed, Br J Dermatol) - "Inclusion criteria were adults who received at least one of the biologics, apremilast or conventional nonbiologics (acitretin, ciclosporin and methotrexate) for ≥ 6 months. All biologics licensed for psoriasis were analysed except for infliximab, which had higher prescription criteria...The certolizumab group had a low mean age of 37.4 years (SD 10.3), the ustekinumab group had a significantly longer median treatment duration of over 4 years (IQR 1.83-6.73), and more patients in the ixekizumab (42.6%) and certolizumab (40.6%) groups had concomitant psoriatic arthritis...IRs (95% CIs) of other tumour necrosis factor-α inhibitors were 15.7 (14.5-17.1) for adalimumab and 16.7 (13.8-20.0) for etanercept. For interleukin-17 inhibitors the IRs (95% CIs) were 18.4 (15.9-21.2) for secukinumab, 7.63 (0.92-27.6) for bimekizumab, 14.5 (7.73-24.8) for brodalumab and 18.5 (14.0-24.0) for ixekizumab. For interleukin-23 inhibitors the IRs (95% CIs) were 13.5 (9.97-17.8) for guselkumab,..."

Journal • Observational data • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A

O05 A retrospective review of cases of psoriasis requiring discontinuation of biologic therapy from 2007 to 2024 in a multisite NHS trust. (PubMed, Br J Dermatol) - "Concurrent systemic immunosuppression (methotrexate or ciclosporin) was prescribed in 21% (n = 31)...The biologics with most interventions were adalimumab or biosimilars (n = 102: Humira n = 39, Idacio n = 30, Hyrimoz n = 23, Amgevita n = 10), ustekinumab (n = 39), secukinumab (n = 35), guselkumab (n = 13) and certolizumab (n = 11)...The main blood abnormality was positive tuberculosis ELISpot assay (interferon-γ release assay) (n = 6: Humira n = 2; and Idacio, ustekinumab, etanercept and risankizumab n = 1 each). Other abnormalities included leucocytosis in sepsis (n = 2; ustekinumab, secukinumab), neutropenia (n = 1; Hyrimoz), raised alanine aminotransferase (n = 1; Humira) and raised fetal calprotectin (n = 1; Ixekizumab)...Blood abnormalities requiring treatment intervention were infrequent, most commonly positive tuberculosis testing. Our findings support reducing blood monitoring of..."

Journal • Retrospective data • Atopic Dermatitis • Dermatology • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Neutropenia • Pain • Psoriasis • Psoriatic Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatology • Septic Shock • Seronegative Spondyloarthropathies • Tuberculosis • Type 2 Diabetes Mellitus • Ulcerative Colitis • Urticaria • IFNG

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

Enhancement of activation-induced T cell proliferation by SIRPG in a CD47-independent manner. (PubMed, Front Immunol) - "We further show that SIRPG serves as a valuable marker for GzmK-expressing CD8+ T cells in peripheral blood and that its expression in both CD4+ and CD8+ T cells is upregulated by anti-CD3 stimulation, with further enhancement by the TNFα inhibitor adalimumab, but not certolizumab. Structural and functional analyses reveal that SIRPG-driven proliferation is independent of its extracellular D1 domain, not significantly affected by the V263 variant, but dependent on its cytoplasmic domain. Collectively, our findings offer novel insights into the expression, function, and mechanism of action of SIRPG in T cells."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • CRTAM • GZMB • GZMK • IFNG • SIRPA • TOP2A • UBE2C

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

Milk, Microbes, and Monoclonals: How Biologic Therapy Might Shape Maternal–Infant Microbiome Dynamics in Hidradenitis Suppurativa (ISDS 2025) - "Pharmacokinetic studies (CRIB and CRADLE) confirm minimal placental and breast milk transfer of certolizumab pegol, highlighting its safety and providing a model to study indirect microbiome effects. Biologic therapy in HS may reshape maternal microbial communities and, through breast milk, alter infant colonization. A prospective multi-omic cohort is needed to test this hypothesis."

Dermatology • Hidradenitis Suppurativa • Immunology

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

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

Real-World Switching and Discontinuation Patterns for Biologic Disease-Modifying Antirheumatic Drugs in Patients with Active Psoriatic Arthritis in Japan. (PubMed, Mod Rheumatol) - "ResultsIncluded patients received adalimumab (n = 323), brodalumab (n = 71), certolizumab pegol (n = 162), guselkumab (n = 157), ixekizumab (n = 239), risankizumab (n = 117), secukinumab (n = 250), or ustekinumab (n = 60). ConclusionSwitching and discontinuation were common within 1-year of bDMARD treatment for PsA patients in Japan. Risankizumab demonstrated the lowest rates of switching and/or discontinuation."

Journal • Real-world evidence • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn's Disease. (PubMed, Gastroenterology) - "This guideline provides a comprehensive, patient-centered, evidence-based approach to the pharmacologic management of patients with moderate-to-severely active CD."

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

On-Label Treatment Persistence Through 24 Months Among Patients with Active Psoriatic Arthritis Initiating Guselkumab or Subcutaneous Tumor Necrosis Factor Inhibitors. (PubMed, Rheumatol Ther) - "Patients with active PsA initiating guselkumab were significantly (approximately two times) more likely to remain persistent with on-label therapy through 24 months versus SC TNFi, overall and among biologic-naïve and biologic-experienced subgroups."

Journal • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Peritoneal Tuberculosis Mimicking Cancerous Peritonitis With Elevated Serum Cancer Antigen 125 and Carbohydrate Antigen 19-9 Levels: A Case Report. (PubMed, Respirol Case Rep) - "We report a 75-year-old woman with rheumatoid arthritis who was receiving certolizumab and developed massive ascites, elevated tumour markers, and pulmonary nodules...While CA19-9 is generally considered a marker for malignancy, it may increase in cases of tuberculosis and bronchiectasis. PTB should be considered in the differential diagnosis even when carcinomatous peritonitis is strongly suspected."

Journal • Bronchiectasis • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Tuberculosis • CA 19-9 • MUC16

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

A Translational Approach to Identifying and Targeting TNF Signaling in Idiopathic Multicentric Castleman Disease (ASH 2023) - "The top three novel predicted treatments for iMCD included two TNF inhibitors, adalimumab and certolizumab pegol, and the B cell depleting agent, rituximab, the second most prescribed drug for iMCD after siltuximab. We utilized a translational research approach including experimental and unbiased machine learning approaches to identify TNF as a novel therapeutic target that we inhibited to treat a highly refractory iMCD patient. Together, our data suggest that over-production of TNF, in part by activated T cells, promotes iMCD pathogenesis and highlight that further research is needed into TNF inhibition as a potential treatment strategy for iMCD."

Clinical • Rare Diseases • CD4 • CXCL8 • IFNG • IL10 • IL4 • STAT3

Comparison of the Risk of Paradoxical Psoriasis between Monoclonal Antibody and Non-monoclonal Antibody Tumor Necrosis Factor-α Inhibitors in Patients with Rheumatoid Arthritis: An Observational Study Using a Claims Database. (PubMed, Biol Pharm Bull) - "Subgroup analyses revealed that compared to etanercept, the HR for adalimumab was 1.43 (95% CI: 0.49-4.19), and compared to certolizumab pegol, it was 0.67 (95% CI: 0.19-2.39). These findings suggest that our hypothesis was not supported and that the risk of paradoxical psoriasis may vary even among non-mAb agents, as indicated by differences observed between etanercept and certolizumab pegol."

Clinical • Journal • Observational data • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Rheumatoid Arthritis • Rheumatology

Predictors of Effectiveness of Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs in the Treatment of Rheumatoid Arthritis (ISPOR-EU 2025) - "Access to anti-TNF (adalimumab, etanercept, infliximab and certolizumab pegol), non-anti-TNF bDMARDs (tocilizumab and abatacept) and tsDMARD (tofacitinib - janus kinase inhibitors - JAKi) requires an administrative approval and dispensing process in the Brazilian Public Health System. Overall, anti-TNF and JAKi groups were more effective. Younger patients also tend to respond better to treatment. This knowledge can help optimise the use of public resources."

Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

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

Presumed abdominal tuberculosis in a patient of recalcitrant Juvenile Idiopathic Arthritis associated uveitis treated with Adalimumab. (PubMed, Oman J Ophthalmol) - "The rising use of biologicals, especially the anti-tumor necrosis factor α inhibitors (anti-TNF-α inhibitors) such as adalimumab, certolizumab pegol, etanercept, and infliximab in cases of recalcitrant uveitis with systemic associations have proved to be an effective treatment of choice. He eventually went on to develop ascites, which were presumed to be tubercular in etiology, and hence, an immediate cessation of the biologic was required. The case highlights the known complications of adalimumab and also emphasizes the need for close monitoring of patients on adalimumab."

Journal • Idiopathic Arthritis • Immunology • Infectious Disease • Ocular Inflammation • Oncology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Rheumatology • Tuberculosis • Uveitis

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

IgAN Following Certolizumab Use (KIDNEY WEEK 2025) - "He was treated with pulse steroids followed by a prednisone taper. Early recognition and biopsy are critical for diagnosis and management. Correlation of Certolizumab antibody level with Creatinine trend"

Acute Kidney Injury • Cardiovascular • Diabetes • Diabetic Nephropathy • Dyslipidemia • Fibrosis • Glomerulonephritis • Hypertension • IgA Nephropathy • Immunology • Inflammatory Arthritis • Lupus Nephritis • Metabolic Disorders • Musculoskeletal Diseases • Nephrology • Orthopedics • Renal Disease • Rheumatoid Arthritis • Rheumatology • Type 2 Diabetes Mellitus

A Patient with Certolizumab Pegol-Induced Palmoplantar Pustulosis or Pustulotic Arthro-Osteitis: A Case Report. (PubMed, Mod Rheumatol Case Rep) - "The patient was treated with methotrexate and certolizumab (tumor-necrosis factor (TNF)-α inhibitor). The skin lesions improved after discontinuation of certolizumab and treatment with ointments and phototherapy. This case suggests that TNF-α inhibitors may potentially trigger PPP in patients with a family history (genetic factor) of the condition."

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

Cost per Responder Analysis of Certolizumab Pegol vs. Adalimumab in Patients With Moderate to Severe Active Rheumatoid Arthritis and High Rheumatoid Factor Levels: A Payer Perspective From France, Germany, Italy, and United Kingdom (ISPOR-EU 2025) - "This study assessed the cost per responder (CPR) of CZP versus adalimumab (ADA) in patients with moderate to severe RA and high RF (>200 IU/mL) from the healthcare payer perspectives of France, Germany, Italy, and the UK. A 104-week (Wk) CPR model was developed using data from EXXELERATE, a phase IV, head-to-head trial comparing CZP+methotrexate (MTX) to ADA+MTX. In patients with moderate to severe RA and high RF levels, CZP at list price demonstrated a lower CPR than ADA biosimilar list price in all four countries at Wk104, with the greatest cost advantage seen in Germany and the UK. However, results should be interpreted with caution, as real-world procurement costs may affect comparative CPR."

Clinical • HEOR • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Biologic-Refractory GI Behçet's Disease Requiring Hemicolectomy: An 8-Year Follow-Up Case Report (ACG 2025) - "She was started on adalimumab (ADA) and prednisone, with partial improvement. Despite weekly ADA and colchicine, she remained steroid-dependent with persistent ischemic-appearing ulcers...She required escalation to infliximab, risankizumab, certolizumab pegol, and most recently is set to start guselkumab...This patient's relapse despite multiple biologics reflects a truly refractory phenotype.Early recognition, multidisciplinary care, and individualized strategies are essential. Further research is needed to identify predictors of response, determine the most effective biologics, and define the role of surgery in refractory GI Behçet's.Figure: Image 1: Active ileal Behcet with deep ischemic appearing ulcers (black arrow) starting at the anastomotic ring and extending to 5 cm proximal to the anastomotic ring, wide open side to side ileocolonic anastomosis.Figure: Image 2: Colonic mucosa showing patchy chronic colitis with focally increased eosinophils (H..."

Case report • Clinical • Cognitive Disorders • Crohn's disease • Eosinophilia • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Rare Diseases • Vasculitis