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

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

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

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

Adalimumab Use in Severe Recalcitrant Vulval Lichen Sclerosus and Vulval Lichen Planus. (PubMed, J Low Genit Tract Dis) - "This case series indicates that SC adalimumab may be a treatment option for patients with severe, refractory VLS and VLP, as demonstrated by significant improvements in PROMs. The observed clinical benefits suggest that adalimumab targets key inflammatory pathways in these conditions. Controlled trials are necessary to further validate these findings and define adalimumab's role in managing severe refractory VLS and VLP. Future research should also investigate long-term efficacy and safety, as well as potential predictors of treatment response, to optimize care for this challenging patient population."

Journal • Dermatology • Dermatopathology • Lichen Planus • Pain

Extended oligoarthritis with proximal muscle weakness and antinuclear antibody positivity associated with a novel genetic variant of uncertain significance in lipopolysaccharide-responsive and beige-like anchor protein (LRBA) gene (BSR-CBC 2024) - "Diagnosis was made of oligoarticular JIA and she was treated with intra-articular steroids in both knees and ankles and was started on oral prednisolone, weekly oral methotrexate...Her methotrexate was changed to subcutaneous and at eight years of age she was also started on subcutaneous adalimumab fortnightly...Treatment with abatacept (a soluble CTLA4 immunoglobulin fusion protein) which is reported in a case series of LRBA deficiency. Risks of continuous immunosuppressive treatment need to be balanced with more definitive hematopoietic stem cell transplantation (HSCT) previously used to achieved complete remission in LRBA deficiency."

IO biomarker • Bone Marrow Transplantation • Hematological Disorders • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Mood Disorders • Musculoskeletal Pain • Myositis • Ocular Inflammation • Ophthalmology • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology • Uveitis • CRP • CTLA4

Reporting Mental Health and Associated Disorders from Trials of Bimekizumab in Patients with Active Axial Spondyloarthritis and Psoriatic Arthritis (ACR Convergence 2024) - P3 | " Treatment-emergent adverse events (TEAEs) reported for pooled phase 2/3 axSpA/PsA trial populations (BE AGILE 1 & 2, BE MOBILE 1 & 2, BE MOVING, AS0013; BE ACTIVE 1 & 2, BE OPTIMAL, BE COMPLETE, BE VITAL)...BE OPTIMAL included an active reference arm (sc adalimumab 40 mg Q2W) to provide a reference for BKZ benefit/risk profile... Across trials of BKZ in pts with axSpA and PsA, eC-SSRS and PHQ-9 scores were low and similar to PBO to Wk 16. Adjudicated SIB, anxiety, and depression rates remained low to 1 yr, despite impacts of the COVID-19 pandemic."

Clinical • Ankylosing Spondylitis • CNS Disorders • Depression • Immunology • Infectious Disease • Inflammatory Arthritis • Mood Disorders • Novel Coronavirus Disease • Psoriatic Arthritis • Psychiatry • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Suicidal Ideation • IL17A

Bimekizumab-Treated Patients with Active Psoriatic Arthritis Showed Sustained Reductions in Disease Impact Assessed by the Psoriatic Arthritis Impact of Disease (PsAID)-12 Questionnaire: Up to 2‑Year Results from Two Phase 3 Studies (ACR Convergence 2024) - P3 | "BE OPTIMAL included a reference arm (sc adalimumab [ADA] 40 mg Q2W); these pts switched to BKZ at Wk 52 (ADA/BKZ) with no washout between treatments. BKZ treatment demonstrated sustained reduction in disease impact up to 2 yrs in pts with PsA who were bDMARD-naïve or TNFi-IR. Pts who switched from ADA to BKZ at Wk 52 showed sustained reduction in disease impact up to 2 yrs."

Clinical • P3 data • Fatigue • Immunology • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A case of previously undescribed uveitis in Kabuki syndrome (BSR-CBC 2024) - "Treatment with mycophenolate mofetil, IM methylprednisolone and SC Adalimumab improved the inflammation but there was deterioration with low right IOP 7 mmHg with an iris bombe. Kabuki syndrome is a congenital disorder with distinctive facial features, infantile hypotonia, developmental delay and intellectual disability among other features. His vision continued to deteriorate leading the team to reflect on whether or not earlier EUA and treatment would have reduced the extent of visual loss in a single functioning eye.Key learning points: • Kabuki syndrome has not previously been associated with uveitis. It is another plausible autoimmune disease to consider, but where a complex unexplained family history exists an alternative unifying diagnosis is possible.• Early diagnosis and management of uveitis is imperative to reduce the risk of future visual loss.• Our duty as medical professionals is to ensure equitable care to all our patients by adapting our assessments and..."

Clinical • Anesthesia • Cataract • Crohn's disease • Developmental Disorders • Gastroenterology • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Mental Retardation • Ocular Inflammation • Ophthalmology • Pain • Pulmonary Disease • Respiratory Diseases • Rheumatology • Sarcoidosis • Strabismus • Uveitis

Adalimumab treatment of resistant chondrocalcinosis. (PubMed, Reumatol Clin (Engl Ed)) - "To our knowledge, this is the first report using adalimumab successfully in severe CPDD. Anti-TNF therapy can be a good therapeutic option for second line therapy in CPPD."

Journal • Metabolic Disorders • Oncology

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."

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

Successful management of recalcitrant hidradenitis suppurativa with tildrakizumab (EADV 2024) - "Materials & We present a case series of 5 patients with Hurley stage I/II HS and comorbid psoriasis who failed conventional medical and surgical treatment modalities, including subcutaneous adalimumab and excision/deroofing. Our case series demonstrates treatment efficacy and sustainability with tildrakizumab for recalcitrant HS. A shorter dose interval than that of its use for psoriasis may be indicated where greater clinical response is required."

Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Pyoderma Gangrenosum • Rheumatology • Seronegative Spondyloarthropathies • IL23A

Multiple switching between the biosimilar adalimumab-fkjp low concentration and reference adalimumab high concentration in patients with chronic plaque psoriasis: a phase 3, double-blind, randomised, parallel-group study (EADV 2024) - "This study confirmed that the subjects receiving adalimumab-fkjp low concentration and adalimumab high concentration in alternate fashion had highly similar time concentration curves compared to continuous administration of adalimumab, and demonstrated PK equivalence between switching and non-switching arms. The efficacy, safety and immunogenicity profile was similar between the arms. The overall data supports interchangeability between adalimumab and adalimumab-fkjp."

Clinical • P3 data • Dermatology • Immunology • Psoriasis

Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies. (PubMed, RMD Open) - P3 | "Bimekizumab treatment demonstrated rapid and greater improvements in patient-reported pain, fatigue, physical function and HRQoL to week 16 vs placebo in bDMARD-naïve and TNFi-IR patients."

HEOR • Journal • P3 data • Fatigue • Immunology • Inflammatory Arthritis • Oncology • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P3 | N=367 | Completed | Sponsor: Celltrion | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

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 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Jul 2024 ➔ Feb 2025 | Trial primary completion date: Jul 2024 ➔ Feb 2025

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

EFFICACY AND SAFETY OF LOW OR HIGH DOSE METHOTREXATE IN COMBINATION WITH ADALIMUMAB IN PATIENTS WITH ELDERLY-ONSET RHEUMATOID ARTHRITIS: RESULTS FROM THE RANDOMISED, CONTROLLED MIRACLE TRIAL (EULAR 2024) - P4 | "In the MIRACLE trial, half of patients were diagnosed with the age of 60 or older. When treated with methotrexate monotherapy, the EORA patients had higher efficacy with higher total polyglutamates concentrations despite lower methotrexate doses. When combined with adalimumab, the SDAI remission rate was not different with a tendency of inferior HAQ remission rate in the reduced dose of methotrexate group."

Clinical • Combination therapy • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology