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

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

Central Nervous System Demyelination Associated with TNF-Alpha inhibitors: A 20-Year Systematic Review (ACTRIMS Forum 2026) - "Certolizumab showed the earliest onset (mean 8.7 months, SD 13.2), adalimumab (mean 17.7, SD 16.3), etanercept (mean 22.5, SD 34.7), Infliximab (mean 27.7, SD 17.0), & golimumab (mean 32.2, SD 56.0)...For the neurological disorder, only 17.4% of patients required long-term management with disease-modifying therapy, most commonly rituximab (26%), ocrelizumab (15%), and glatiramer with interferon combination (15%)...Following TNF-alpha-inhibitor cessation, 29.03% experienced worsening of their systemic autoimmune condition & 9.6 % required alternative biological therapy, commonly secukinumab, ustekinumab, tocilizumab, or methotrexate... TNF-α inhibitors, though effective for autoimmune diseases, may unpredictably be associated with CNS demyelination. Most often linked with adalimumab, etanercept, and infliximab. While many patients recover after discontinuing steroids, some have persistent deficits, underscoring the need for cautious use and close neurological..."

Review • CNS Disorders • Immunology • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis

Stand UP to Rheumatoid Arthritis (SUPRA) (clinicaltrials.gov) - P=N/A | N=75 | Recruiting | Sponsor: Marie Hudson, MD | Trial completion date: Dec 2026 ➔ Dec 2030 | Trial primary completion date: Dec 2025 ➔ Dec 2028

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Hepatobiliary disorders associated with TNF-α inhibitors: a pharmacovigilance analysis of FAERS and JADER. (PubMed, Front Immunol) - "We analyzed the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) data and Japanese Adverse Drug Event Report Database (JADER) data for five TNF-a inhibitors (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab) listed as primary suspects. Male sex and skin and subcutaneous tissue disorders were regarded as consistent independent risk factors. The factors of drug dose, body weight, and additional comorbidity clusters could also require attention in clinics because these factors were obviously observed in certain single databases."

Adverse events • Journal • Hepatology • Oncology • Rheumatology

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

Negotiations with participating drug companies will occur in 2026 and any negotiated and renegotiated prices will become effective January 1, 2028. (CMS Press Release) - "The selected drug list for the third cycle of negotiations is: Anoro Ellipta...Botox; Botox Cosmetic; Cimzia; Cosentyx; Entyvio...Orencia...Trulicity....Xeljanz; Xeljanz XR; Xolair."

Medicare • Allergy • Ankylosing Spondylitis • Asthma • Chronic Obstructive Pulmonary Disease • Crohn's disease • Idiopathic Arthritis • Immunology • Migraine • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

The Effect of Certolizumab Pegol Dose and Dose Changes on Plasma Trough Levels: Data From a Randomized Phase III Trial. (PubMed, Ther Drug Monit) - "CZP plasma concentrations were influenced by both dose and dose adjustment in a predictable manner, with median plasma levels twice as high in the 400-mg group than in the 200-mg group, with a 2-fold increase after the dose increase from 200 to 400 mg. This facilitates the development of algorithms for therapeutic drug monitoring of CZP."

Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Do high rheumatoid factor levels impact response to certolizumab pegol in patients with inadequately controlled rheumatoid arthritis? A post hoc analysis of the phase IIIb REALISTIC trial. (PubMed, RMD Open) - P3 | "Patients with high and low RF levels experienced similar clinical responses to CZP treatment, irrespective of previous inadequate responses or intolerance to TNFis. These findings expand previous observations, supporting CZP as an effective treatment for patients with RA who have high RF levels and prior inadequate responses to TNFis."

Biomarker • Clinical • Journal • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • CRP

Erosive Oral Lichen Planus Treated With Upadacitinib Amid Systemic Psoriatic Therapy. (PubMed, Cureus) - "First-line therapies are topical corticosteroids or calcineurin inhibitors, while erosive OLP may require intralesional triamcinolone...Previous treatments, including prednisone, clobetasol gel, dexamethasone, chlorhexidine rinses, and mycophenolate, provided little relief. As her OLP remained unresponsive to treatment, her psoriasis also proved challenging, necessitating multiple therapeutic adjustments. She was started on apremilast for her PsO and PsA, which was ineffective. She transitioned to certolizumab pegol, which provided partial relief but led to recurrent infections. Bimekizumab was then initiated, clearing her PsO, but leaving her with persistent joint pain...Given the inflammatory pathway overlap between PsA and LP, JAK inhibition may mitigate the chronic inflammatory cascade that drives erosive OLP. Upadacitinib's efficacy in this case of refractory erosive OLP warrants further clinical studies to establish its therapeutic role."

Journal • Dermatology • Dermatopathology • Immunology • Infectious Disease • Inflammatory Arthritis • Lichen Planus • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • JAK3

Recent advances in biologic therapies for ankylosing spondylitis: A 2024 update. (PubMed, Allergol Immunopathol (Madr)) - "This comprehensive analysis assesses therapeutic outcomes and adverse effects of TNFi, IL17i, and JAKi in AS care."

Journal • Review • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Oncology • Rheumatology • Seronegative Spondyloarthropathies • IL17A

A Head-to-Head Comparison of TNF-α Inhibitors as the First Biologic Treatment of Rheumatoid Arthritis. (PubMed, Rheumatology (Oxford)) - "This hypothesis-generating study provides evidence that TNFis may not be equally effective. The uncertainty in the estimates highlights the need for a pragmatic randomized controlled trial to validate the findings. With decreasing costs of TNFis, such studies are increasingly feasible and critical to guide clinical decision-making."

Head-to-Head • Journal • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Evaluation of the placebo and treatment effect overtime in randomised clinical trials evaluating the efficacy of biologics in axial spondyloarthritis: systematic review and meta-analysis. (PubMed, Ann Rheum Dis) - "ASAS20/40 treatment effects have declined over time in axSpA trials, consistent with a fading of reported effectiveness, whereas ASDAS-based endpoints remain stable, indicating greater robustness to placebo effects and temporal trends."

Journal • Retrospective data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Oncology • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • CRP • IL17A

Predicting self-administered biologic nonadherence in Medicare fee-for-service beneficiaries with inflammatory bowel disease using machine learning models. (PubMed, J Manag Care Spec Pharm) - "Beneficiaries with missing data or fewer than 3 self-administered biologic dispenses (adalimumab, certolizumab, golimumab, ustekinumab) on different dates in 2021 were excluded. Machine learning models trained on Medicare fee-for-service claims data had fair predictive performance identifying nonadherent dispenses. The bagging model, which minimizes false negatives, may be most appropriate for future clinical decision support tools."

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

Pyoderma Gangrenosum with Biological Agents Therapy: A Systematic Review. (PubMed, Clin Cosmet Investig Dermatol) - "The number of included cases and the efficacy are Infliximab (n=52, 88.4%), Adalimumab (n=23, 91.3%), Etanercept (n=13, 84.6%), Certolizumab (n=3, 66.6%), Golimumab (n=1, 100.0%), Anakinra (n=11, 100.0%), Canakinumab (n=7, 100.0%), Secukinumab (n=5, 40.0%), Brodalumab (n=3, 100.0%), Ixekizumab (n=1, 100.0%), Ustekinumab (n=12, 100.0%), Spesolimab (n=3, 100.0%), Guselkumab (n=2, 100.0%), Tildrakizumab (n=2, 100.0%), Risankizuma (n=1, 100.0%). However, IL inhibitors demonstrate an advantage with shorter treatment cycles. Additionally, Infliximab has a wider range of side effects and should be used with caution.PROSPERO number: CRD42024608039."

Journal • Review • Oncology • Pain • Pyoderma Gangrenosum • Rare Diseases

Certolizumab-associated autoimmune-like hepatitis. (PubMed, BMJ Case Rep) - "Tumour necrosis factor alpha (TNF-α) inhibitors are licensed for use in autoimmune conditions such as psoriasis, and there have been reported cases of liver injury associated with infliximab and adalimumab use. Following the drug discontinuation, the patient's liver function tests normalised and, through ongoing follow-up, was noted to remain stable. This case highlights that drug-induced autoimmune-like hepatitis is associated across the TNF-α inhibitor class and must be taken into consideration when commencing any of them."

Journal • Dermatology • Hepatology • Immunology • Inflammation • Liver Failure • Oncology • Psoriasis

CIMcare: A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=49 | Recruiting | Sponsor: UCB Biopharma SRL | N=150 ➔ 49

Enrollment change • Dermatology • Immunology • Pediatrics • Psoriasis

A systematic review of therapeutic and paradoxical roles of tumor necrosis factor α inhibitors in autoimmune blistering diseases. (PubMed, Inflammopharmacology) - "TNF-α inhibitors, particularly infliximab, show therapeutic promise in refractory AIBDs. However, their potential to paradoxically induce blistering diseases, especially with adalimumab and etanercept, necessitates careful patient selection, close monitoring, and individualized risk-benefit assessment."

Journal • Review • Bullous Pemphigoid • Crohn's disease • Dermatitis • Dermatology • Dermatopathology • Gastroenterology • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Pemphigus Vulgaris • Rheumatoid Arthritis • Rheumatology

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