Humira SC (adalimumab/hyaluronidase) / AbbVie, Halozyme - LARVOL DELTA

Comment on 'Intravitreal versus Subcutaneous Adalimumab in Active Non-Infectious Uveitis: A Randomized Non-Inferiority Trial'. (PubMed, Ocul Immunol Inflamm) - "report that intravitreal adalimumab is non-inferior to subcutaneous administration for controlling intraocular inflammation in non-infectious uveitis. This correspondence discusses the broader clinical implications of these findings, highlighting cost considerations, the need to balance systemic safety with local procedural risks, and the importance of patient-reported outcomes and extended dosing regimens to enhance treatment acceptability."

Head-to-Head • Journal • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

SELECT- SWITCH: Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=487 | Active, not recruiting | Sponsor: AbbVie | Trial primary completion date: Aug 2025 ➔ Jul 2026

Adverse events • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Bimekizumab Treatment Resulted in Long-Term Sustained Reductions in Disease Impact Assessed by the Psoriatic Arthritis Impact of Disease (PsAID)-12 Questionnaire in Patients with Active Psoriatic Arthritis: Up to 3-Year Results from Two Phase 3 Studies (ACR Convergence 2025) - P3 | "BE OPTIMAL included a reference arm (sc adalimumab 40 mg Q2W; data not shown). BKZ treatment resulted in clinically meaningful improvements in PsAID-12 scores across physical, social and psychological domains in pts with active PsA, indicating reduced disease impact. Improvements were sustained to 3 yrs and consistent responses were seen in pts who were bDMARD-naive or had TNFi-IR."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A

INTRAVENOUS INFLIXIMAB, SUBCUTANEOUS INFLIXIMAB AND SUBCUTANEOUS ADALIMUMAB AS "TOP-DOWN" TREATMENT FROM DIAGNOSIS, ARE ALL MORE EFFECTIVE, SAFER AND LESS COSTLY THAN CONVENTIONAL 'STEP-UP' CARE FOR PATIENTS WITH ACTIVE CROHN'S DISEASE (UEGW 2025) - "This health economic analysis demonstrates that early effective "top-down" treatment with anti-TNF therapy from diagnosis results in lower healthcare resource use compared to an "accelerated step-up" strategy. The economic benefits align with improved clinical outcomes, as early, effective treatment better controls inflammation. Patients experience longer periods in remission, fewer disease-related flares, and enhanced quality of life."

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

Crohn's disease-like perianastomotic ulcerations after neonatal necrotizing enterocolitis surgery: a case of successful anti-TNF therapy. (PubMed, BMC Pediatr) - "Early anti-TNF therapy induced rapid and sustained remission in a pediatric patient with DPAU, reinforcing the mechanism that TNF-α-driven inflammation underlies disease pathogenesis. While promising, these findings require validation in larger cohorts. Individualized therapeutic decisions should weigh the risks of recurrence, cost, and long-term biologic safety."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Bowel Disease • Oncology • Pain • Pediatrics

Disseminated necrobiosis lipoidica with sustained therapeutic response to adalimumab and dapsone (EADV 2025) - "Other therapeutic modalities include hydroxychloroquine, cyclosporine, and phototherapy (PUVA), with surgical approaches reserved for localized ulcerated cases. The diagnosis of necrobiosis lipoidica is based on clinicopathological correlation. Clinically, it presents with sclerotic erythematous halos, atrophic pink-yellow centers, and telangiectasias. Histopathologically, there is degeneration of dermal collagen, lymphohistiocytic inflammatory infiltrate, and occasionally, palisading granulomas."

Dermatology • Diabetes • Immunology • Metabolic Disorders • Primary Immunodeficiency

Bullous pyoderma gangrenosum successfully treated with adalimumab: a case report (EADV 2025) - "The patient received intravenous methylprednisolone (40 mg/day, 1 week), human immunoglobulin (20 g/day, 3 days), and doxycycline (0.1 g/day, 1 week) with minimal improvement (Fig. Infectious diseases, vasculitis, and malignancies were excluded through clinical, histopathological, and lab evaluations. Adalimumab and low-dose glucocorticoids achieved rapid disease control and ulcer healing."

Case report • Clinical • Infectious Disease • Pyoderma Gangrenosum • Vasculitis • CXCL8 • IL15 • IL17A

Real-world use of biologics for systemic juvenile idiopathic arthritis: information from a Japanese hospital claims database. (PubMed, Mod Rheumatol) - "Our study described the real-world usage of biologics for sJIA in Japan."

Journal • Real-world evidence • Idiopathic Arthritis • Immunology • Oncology • Rheumatology

Treating apalutamide-induced toxic epidermal necrolysis with adalimumab and baricitinib in a patient with prostate cancer (EADV 2025) - "A multidisciplinary therapeutic strategy was instituted comprising high-dose intravenous immunoglobulin (20 g/day) for immunomodulation, pulse methylprednisolone (80 mg IV twice daily) as the initial anti-inflammatory intervention, subcutaneous adalimumab (80 mg weekly) for targeted TNF-α blockade, and oral baricitinib (2 mg twice daily) to inhibit JAK1/2-mediated signaling pathways. This case demonstrates TNF-α inhibitor/JAKi combination therapy effectively manages refractory TEN in cancer patients, through synergistic immunomodulation and neutralizing cytokine storms. The regimen achieved rapid re-epithelialization with reduced steroid dependence, addressing malignancy-associated immune dysregulation. Large-scale clinical studies are still needed to explore the clinical potential of TNF-α inhibitor and JAKi in cancer patients with TEN."

Clinical • Genito-urinary Cancer • Immunology • Oncology • Prostate Cancer • Solid Tumor • Steven-Johnson Syndrome

A RARE CAUSE OF SEVERE UPPER AIRWAY OBSTRUCTION-A DIAGNOSTIC DILEMMA AND MANAGEMENT CHALLENGE. (MTS 2025) - "Despite aggressive immunosuppression with intravenous methylprednisolone, methotrexate, cyclophosphamide, and mycophenolate mofetil, she experienced disease progression complicated by steroid toxicity and recurrent infections. Subcutaneous adalimumab was initiated with partial response...Conclusion RPC should be considered in pediatric patients with recurrent upper airway obstruction. Early diagnosis and a multidisciplinary approach are crucial to prevent severe complications and manage disease progression effectively."

Conjunctivitis • Immunology • Infectious Disease • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics • Pulmonary Disease • Respiratory Diseases

Effectiveness of intravenous infliximab versus subcutaneous adalimumab in Takayasu arteritis: multicenter retrospective study. (PubMed, Rheumatology (Oxford)) - "In this study, we confirm that infliximab and adalimumab are both effective in TAK, without significant differences in the risk of relapse and revascularizations."

Journal • Retrospective data • Vasculitis

Intravitreal versus Subcutaneous Adalimumab in Active Non-Infectious Uveitis: A Randomized Non-Inferiority Trial. (PubMed, Ocul Immunol Inflamm) - "Secondary outcomes included best-corrected visual acuity (BCVA), central retinal thickness (CRT), fluorescein angiography (FA) score, and oral prednisone dose. A total of 23 patients (43 eyes) were randomized into the SCA (n = 12) or IVA (n = 11) treatment group. No serious systemic or ocular adverse events (AE) were observed. SCA resulted in a higher number of non-serious systemic AE (21) compared to IVA (5). IVA was non-inferior to SCA in treating active NIU and resulted in fewer systemic adverse events."

Head-to-Head • Journal • Ocular Inflammation • Ophthalmology • Uveitis

A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Takeda | N=150 ➔ 100

Enrollment change • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

INHIBITION OF RADIOGRAPHIC PROGRESSION WITH BIMEKIZUMAB TREATMENT OBSERVED IN BDMARD-NAÏVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AT 2 YEARS: RESULTS FROM A PHASE 3 STUDY AND ITS OPEN-LABEL EXTENSION (EULAR 2025) - P3 | "BE OPTIMAL included a reference arm (subcutaneous adalimumab [ADA] 40 mg every 2 weeks); these patients switched to BKZ at Week 52 (ADA/BKZ) with no washout between treatments. Inhibition of radiographic progression was observed at 2 years with BKZ treatment in bDMARD-naïve patients with active PsA, with most patients experiencing no radiographic progression, regardless of original randomisation group."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP • IL17A

SELECT- SWITCH: Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=480 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects (clinicaltrials.gov) - P1 | N=324 | Recruiting | Sponsor: Prestige Biopharma Limited | Trial completion date: Nov 2024 ➔ May 2026 | Trial primary completion date: Nov 2024 ➔ Feb 2026

Trial completion date • Trial primary completion date

Influence of Disease Type and Activity on Adalimumab Exposure in Children with Inflammatory Rheumatic Diseases. (PubMed, J Clin Pharmacol) - "In addition to disease type (juvenile idiopathic arthritis [JIA] vs idiopathic uveitis) and disease activity (inactive/mild/minimal/moderate/severe), associations between methotrexate (MTX) co-administration and duration of adalimumab treatment with apparent clearance (CL/F) were investigated. Together with increasing knowledge on exposure-response relationships in PIRD, the developed PMX model may be applied to optimize and personalize tapering or dose escalation in PIRD patients. This research identified disease-specific factors that can influence adalimumab exposure, which in turn can inform design and set-up of larger prospective clinical studies."

Journal • Idiopathic Arthritis • Immunology • Ocular Inflammation • Oncology • Ophthalmology • Pediatrics • Rheumatology • Uveitis • TNFA

Association of tattoos with cutaneous sarcoidosis and anterior uveitis. (PubMed, BMJ Case Rep) - "This is likely due to a combination of exaggerated inflammatory responses and granuloma formation at tattoo sites from a chronic foreign body reaction or immune activation. We present a case of tattoo-associated cutaneous sarcoidosis with uveitis in which the patient had an elevated ACE level and was successfully treated with prednisone eye drops and weekly subcutaneous adalimumab."

Journal • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Sarcoidosis • Uveitis

Influence of volume and citrate on perceived pain in patients treated with adalimumab. (PubMed, Eur J Hosp Pharm) - "Our results show that in all three scenarios, perceived pain was reduced. If both volume and citrate are reduced, this effect is greater. Therefore, it is recommended to use formulations with the lowest citrate buffer concentration and the lowest possible volume to minimise pain during adalimumab administration."

Journal • Inflammation • Pain • Rheumatology

Serous retinal detachment secondary to bilateral choroidal osteoma successfully treated with subscleral sclerectomy: A case report. (PubMed, Am J Ophthalmol Case Rep) - "SRD in both eyes recurred frequently and was uncontrolled with adalimumab subcutaneous injections and oral cyclosporine, in addition to steroids. Choroidal osteoma can cause severe SRD that cannot be controlled with medication. Although further studies are needed, subscleral sclerectomy may be an effective treatment for the resolution of subretinal fluid secondary to choroidal osteoma by improving choroidal circulation congestion."

Journal • Inflammation • Retinal Disorders

A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity In Adult Participants With Moderate to Severe Active Crohn's Disease (CD) (clinicaltrials.gov) - P=N/A | N=156 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Adverse events • Trial completion • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Association of methotrexate polyglutamates concentration with methotrexate efficacy and safety in patients with rheumatoid arthritis treated with predefined dose: results from the MIRACLE trial. (PubMed, Ann Rheum Dis) - P4 | "The MIRACLE trial demonstrated that higher total MTX-PGs concentration in erythrocytes is related to the higher efficacy and lower safety of MTX."

Clinical • Journal • Hepatology • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

AMPLIFIED: A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate (clinicaltrials.gov) - P3 | N=338 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Sep 2025 ➔ Sep 2027

Head-to-Head • Trial completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Network Meta-analysis to Evaluate the Comparative Efficacy of Advanced Therapies as First-Line Treatment for Maintenance Treatment of Adult Patients With Moderate to Severe Crohn's Disease (AIBD 2024) - "Background: Subcutaneous (SC) CT-P13 provides patients and physicians with a new opportunity for maintenance treatment of Crohn's disease (CD)... Eligible studies, identified by systematic literature review (PROSPERO no: CRD42023413752), evaluated the efficacy of maintenance therapy using intravenous (IV) or SC infliximab, SC adalimumab, IV or SC vedolizumab, SC ustekinumab, SC risankizumab or oral upadacitinib, in patients with moderate to severe CD who responded to induction therapy... In this updated NMA, SC infliximab 120 mg Q2W demonstrated a favorable profile in achieving clinical remission and endoscopic response when administered as a first-line advanced therapy for maintenance treatment of patients with moderate to severe CD."

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

Immune regulatory adjuvant approach to mitigate subcutaneous immunogenicity of monoclonal antibodies. (PubMed, Front Immunol) - "Formulations of adalimumab, trastuzumab or rituximab with OPLS showed reduction in relative immunogenicity in mice compared to vehicle formulations, indicated by reduced anti-drug antibody development and significant reductions in CD138+ plasma cell differentiation in bone marrow. This adjuvant does not impact immune competence of non-human primates and mice, and repeated administration of the adjuvant does not show renal or hepatic toxicity. Formulation of monoclonal antibodies with the immunoregulatory adjuvant, OPLS, was found to be safe and effective at mitigating immunogenicity."

Journal • Hepatology • CD4 • SDC1