apremilast / Generic mfg. - LARVOL DELTA

Treatment Survival and Reasons for Discontinuation in Patients with Recalcitrant Folliculitis Decalvans. (PubMed, Acta Derm Venereol) - "During the study period, all patients received at least one pre-scription for topical therapies, primarily non-antibiotic disinfectants, topical corticosteroids, topical antibiotics, and topical dapsone. Systemic antibiotics were prescribed for 88.9% of patients, predominantly tetra-cyclines and a combination of rifampicin and clindamycin. Non-biological systemic therapies, excluding steroids, were used in 61.1% of patients, with isotretinoin being the most common (27.8%). Among immunomodulatory drugs, apremilast was prescribed to 11.1% of patients...Antibiotics are often used as a first-line treatment, but they are associated with a high rate of discontinuation. This highlights the urgent need for effective immunomodulatory treatments, either as alternatives or as adjuncts to current options."

Journal • Inflammation

Inflammation (Amgen Press Release) - "TEZSPIRE (tezepelumab-ekko) sales increased 40% year-over-year to $377 million in the third quarter...Otezla (apremilast) sales increased 4% year-over-year to $585 million in the third quarter...Enbrel (etanercept) sales decreased 30% year-over-year to $580 million in the third quarter, primarily driven by 38% lower net selling price resulting from the impact of the U.S. Medicare Part D redesign and increased 340B Program mix, partially offset by favorable changes to estimated sales deductions and volume growth; AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales decreased 7% year-over-year to $154 million in the third quarter...PAVBLU (aflibercept-ayyh) generated $213 million of sales in the third quarter; WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $44 million of sales in the third quarter."

Sales • Ankylosing Spondylitis • Asthma • Crohn's disease • Diabetic Macular Edema • Diabetic Retinopathy • Immunology • Psoriatic Arthritis • Retinal Vein Occlusion • Rheumatoid Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Apremilast improves cardiomyocyte cohesion and arrhythmia in different models for arrhythmogenic cardiomyopathy. (PubMed, Stem Cell Res Ther) - "Apremilast improves loss of cardiomyocyte cohesion, enhances localization of DSG2, and reduces arrhythmia in human and/or murine models of ACM ex vivo and in vitro, providing a novel treatment strategy for ACM by preserving desmosome function."

Journal • Cardiomyopathy • Cardiovascular • Dermatology • Heart Failure • Immunology • Pemphigus Vulgaris • DSG2

Anti-CD19 chimeric antigen receptor T-cell therapy for patients with non-Hodgkin's lymphoma and concurrent autoimmune disease (ASH 2025) - "methotrexate, hydroxychloroquine (HCQ),azathioprine); 9 required biologic/targeted DMARD (ex. adalimumab, etanercept, risankizumab,infliximab, rituximab).DMARDs were weaned prior to CART however 9 pts (37.5%) remained on AID tx at the time of cellcollection, including HCQ (n=4), sulfasalazine/mesalamine (n=2), and 1 each of prednisone, colestipol,sulfasalazine, and apremilast... In this single center study of pts receiving CART for NHL we found no difference in responserates nor survival outcomes in pts with or without AID and therefore propose that AID should notpreclude the use of CART. Lower severity of ICANS was seen in AID pts, though additional study withlarger cohorts is required. The majority of pts were able to taper off AID tx prior to CART, while HCQ wasable to be safely continued throughout CART collection with no apparent effect on CART efficacy."

CAR T-Cell Therapy • Clinical • Ankylosing Spondylitis • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Dermatology • Dermatomyositis • Gastroenterology • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lymphoma • Myasthenia Gravis • Myositis • Non-Hodgkin’s Lymphoma • Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Apremilast for Oral Mucosal-Predominant Resistant Pemphigus Vulgaris: A Promising Adjunctive Treatment. (PubMed, Oral Dis) - No abstract available

Journal • Dermatology • Immunology • Pemphigus Vulgaris

Inhibition of Structural Damage Progression With Guselkumab in Participants With Active Psoriatic Arthritis: Results Through Week 24 of the Phase 3b, Randomized, Double-Blind, Placebo-Controlled APEX Study (ACG 2025) - "Here, we report Week 24(W24) results. APEX enrolled biologic naïve adults with active PsA (≥3 tender & ≥3 swollen joints; C-reactive protein ≥0.3mg/dL) and ≥2 erosive joints on radiographs of hands and feet despite previous non-biologic DMARDs, apremilast, or NSAIDs. BL characteristics were similar across groups. Mean duration of PsA(7.3yrs), PsA-modified vdH-S total(27.0) and erosion(13.5) scores, and tender(20.7) and swollen(11.9) joint counts indicated established, highly active joint disease. Primary and major secondary endpoints were met."

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

Ustekinumab in the Treatment of Intestinal Manifestations of Behcet's Disease (ACG 2025) - "Biopsy of the lesion showed vulvular neutrophilic dermatoses which prompted initiation of prednisone and cyclosporine. The patient developed hypertension on this regimen and transitioned to azathioprine...She was switched to adalimumab, colchicine and hydroxychloroquine by rheumatology...The medical team attempted methotrexate to prevent chronic glucocorticoid use, but the patient self-discontinued this medication due to gastrointestinal intolerance...She remains in clinical remission on Ustekinumab, apremilast, and sulfasalazine. A group of patients with intestinal BD experience disease refractory to mainstay therapy...This case demonstrates that, in patients with intestinal BD, Ustekinumab appears to be a potentially effective treatment. It represents a promising treatment option for intestinal BD, and further studies are needed."

Cardiovascular • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hypertension • Immunology • Inflammation • Inflammatory Bowel Disease • Rare Diseases • Rheumatology

Inhibition of Structural Damage Progression with Guselkumab, a Selective IL-23i, in Participants with Active PsA: Results Through Week 24 of the Phase 3b, Randomized, Double-Blind, Placebo-Controlled APEX Study (ACR Convergence 2025) - P3 | "The study reported findings through Week (W)24 of the ongoing phase 3b, randomized, double-blind, placebo (PBO)-controlled APEX study (NCT04882098), aimed at further evaluating GUS effects on clinical and radiographic outcomes in participants (pts) with active PsA. APEX enrolled biologic-naïve adults with active PsA (≥3 tender and ≥3 swollen joints; C-reactive protein ≥0.3 mg/dL) and ≥2 joints with erosions on radiographs of hands and feet, despite previous non-biologic DMARDs, apremilast, or NSAIDs. APEX is the first study to show significant inhibition of structural progression with both Q4W and Q8W of GUS, a dual-acting selective IL-23i. The GUS safety profile in these biologic-naïve pts with active PsA is consistent with that previously established for GUS across a broad range of pts with PsA, psoriasis, and/or inflammatory bowel disease."

Clinical • P3 data • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • CRP • IL23A

Evaluating Biologic Effectiveness in Co-Occurring Dermatologic and Rheumatic Disease: A Systematic Review (ACR Convergence 2025) - "Biologics included: adalimumab, secukinumab, etanercept, infliximab, ustekinumab, ixekizumab, guselkumab, risankizumab, apremilast, baricitinib, ruxolitinib, brodalumab, dupilumab, and belimumab. This review highlights the expanding role of biologics in the treatment of rheumatologic conditions beyond their primary dermatologic indications. Their interdisciplinary applications present new opportunities for research and clinical practice, underscoring the need for further investigation to optimize their use and broaden their therapeutic scope."

Review • Ankylosing Spondylitis • Dermatology • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Systemic Lupus Erythematosus • IL17A • IL23A

Tolerance of non-TNF α treatments in patient with an inflammatory rheumatic (IRD) and autoimmune demyelinating diseases: French retrospective cases series (ACR Convergence 2025) - "The use of non-anti-TNF targeted therapies (anti-IL17, anti-IL6R, CTLA-4Ig, Jaki, anti-IL23, anti-CD20, PDE4 inhibitor, and anti-IL-12 and IL-23) in patients with RIC does not appear to worsen demyelinating disease."

Retrospective data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL12A • IL17A • IL23A

PDE4 inhibitor apremilast rebalances inflammatory responses to Pseudomonas aeruginosa infection in CF rats (NACFC 2025) - "We previously found Apremilast (Apr), an FDA-approved phosphodiesterase-4 (PDE4) inhibitor for psoriasis, enhances CFTR activation and mucus transport in CF models in addition to Ivacaftor (Iva). PDE4 inhibition represents a promising therapeutic approach for CF, offering dual benefits of anti-inflammatory action and enhanced CFTR function. The synergistic action of PDE4 inhibitors with CFTR modulators to activate CFTR clearly indicates the compatibility of these drugs with HEMT in managing CF by directly addressing inflammatory damage and accelerate decline. The findings of our in vivo study also provide insights into molecular pathways that can be targeted to discover novel anti-inflammatory drugs."

Preclinical • Cystic Fibrosis • Dermatology • Genetic Disorders • Infectious Disease • Inflammation • Psoriasis • Respiratory Diseases • IFNG • IL17A • IL1B • IL6 • TNFA

Immune checkpoint inhibitor associated lichenoid eruptions: a review of non-steroidal systemic maintenance therapies. (PubMed, Support Care Cancer) - "Low-dose methotrexate and systemic retinoids are the most frequently used non-steroidal medications to treat ICI-induced LEs and have the strongest efficacy data to support their use. Promising emerging therapeutics include dupilumab, hydroxychloroquine, apremilast, and interleukin (IL)-17 inhibitors. While anti-inflammatory antibiotics have also been used to treat ICI-induced LEs, antibiotics should generally be avoided as they can alter the gut microbiome, which can lead to decreased ICI efficacy and an increased risk of colitis. Further controlled and systematic clinical studies are warranted to refine treatment approaches to ICI-induced LEs."

Checkpoint inhibition • Journal • Review • Dermatology • Dermatopathology • Gastroenterology • Gastrointestinal Disorder • Immunology • Lichen Planus • Oncology

Effectiveness and safety of Anifrolumab in Non-Systemic Cutaneous Lupus (ACR Convergence 2025) - "The mean disease duration prior to anifrolumab initiation was 32.9±30.2 months.Before starting anifrolumab, patients had received the following treatments: topical glucocorticoids (n=10), hydroxychloroquine (n=10), methotrexate (n=7), oral glucocorticoids (n=5), chloroquine (n=3), azathioprine (n=2), belimumab (n=2), rituximab (n=2), mepacrine (n=1), thalidomide (n=1), apremilast (n=1), and mycophenolate mofetil (n=1).Anifrolumab was administered at a dose of 300 mg intravenously every 4 weeks, either in combination with other therapies (n=9) or as monotherapy (n=1). Anifrolumab appears to be an effective and well-tolerated treatment for patients with refractory non-systemic cutaneous lupus."

Clinical • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IFNAR2

Ocular Involvement in Behçet's Disease: Comparative Study of Two Classification Criteria in Clinical Practice (ACR Convergence 2025) - "ICBD criteria showed greater sensitivity than ISG, specially due to the absence of oral ulcers in certain patients. Classifying these additional patients by ICBD facilitated the initiation of on-label biologic treatments (e.g., monoclonal anti-TNF), potentially improving the management of BD, particularly for those with ocular involvement and without oral ulcers."

Clinical • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology • Rare Diseases • Rheumatology • Scleritis • Uveitis

PDE4-Selective Inhibition in Chronic Obstructive Pulmonary Disease and Pulmonary Fibrosis: Different Agents or Different Targets? (PubMed, Life (Basel)) - "Highly selective inhibitors of the members of the cAMP-selective cyclic nucleotide phosphodiesterases, or PDE4 family, have shown clinically meaningful activity in two different classes of lung disease: roflumilast in obstructive lung disease, specifically chronic obstructive pulmonary disease (COPD), and nerandomilast in restrictive lung diseases characterized by inflammation/fibrosis of the alveolar interstitium, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)...The emerging data are compatible with PDE4-selective inhibitors having targets of action in a large number of pulmonary cell types, only a subset of which is dysregulated in either COPD or IPF. This suggests that differences between the benefits observed with these individual agents in their various clinical indications reflect differences in disease pathogenesis, rather than proven differences in the enzyme-inhibitory effects of the various PDE4 inhibitors that have been..."

Journal • Review • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Integrated experimental, computational and machine learning approaches for the development of Apremilast-Aceclofenac coamorphous systems. (PubMed, Int J Pharm) - "Accelerated stability testing (40 °C/75 % RH) showed sustained amorphous stability, while forced degradation studies revealed lower degradation rates. This integrative framework provides a predictive, mechanistic basis for CAMs design and offers a broadly applicable strategy for dual-drug delivery in inflammatory disorders such as psoriasis."

Journal • Dermatology • Immunology • Inflammation • Psoriasis • IL17A • IL23A • TNFA

Apremilast as a novel therapeutic option for psoriasis coexisting primary sclerosing cholangitis and ulcerative colitis: A case report. (PubMed, Medicine (Baltimore)) - "This case underscores the potential response and tolerability of apremilast as an alternative treatment for psoriasis coexisting with autoimmune liver disease and inflammatory bowel disease."

Journal • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Liver Failure • Pruritus • Psoriasis • Ulcerative Colitis

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment (clinicaltrials.gov) - P3 | N=693 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

USTEKINUMAB-ASSOCIATED EOSINOPHILIC PNEUMONIA IN A PATIENT WITH PSORIASIS (CHEST 2025) - "CASE PRESENTATION: A 59-year-old male with a longstanding history of psoriasis, previously managed with methotrexate and apremilast, was transitioned to ustekinumab for better disease control. This case adds to the limited reports of ustekinumab-associated eosinophilic pneumonia and underscores the importance of considering medication-induced etiologies in patients with unexplained respiratory symptoms on biologic therapy. Given the increasing use of biologic agents, clinicians should remain vigilant for drug-induced pulmonary toxicity. Early recognition, discontinuation of the offending agent, and timely corticosteroid therapy are critical for favorable outcomes [2,3]."

Clinical • Allergic Bronchopulmonary Aspergillosis • Asthma • Cognitive Disorders • Cough • Cystic Fibrosis • Dermatology • Eosinophilic Granulomatosis With Polyangiitis • Genetic Disorders • Immune Modulation • Immunology • Infectious Disease • Langerhans Cell Histiocytosis • Pneumonia • Psoriasis • Rare Diseases • Respiratory Diseases • Vasculitis • IL12A

Identification of a novel PDE4 inhibitor inspired by leoligin-derived lignans. (PubMed, Eur J Med Chem) - "Marketed PDE4 inhibitors, such as roflumilast and apremilast, treat chronic obstructive pulmonary disease and psoriasis. Lastly, a functional study was conducted in LPS-activated macrophages, where LT-104A reduced nitric oxide release and decreased mRNA expression of Il1b and Nos2. In conclusion, extensive in vitro screening of leoligin analogues led to the identification and characterisation of a novel PDE4 inhibitor, LT-104A, with potential in vitro anti-inflammatory properties."

Journal • Chronic Obstructive Pulmonary Disease • Dermatology • Immunology • Psoriasis • Pulmonary Disease • Respiratory Diseases • IL1B • NOS2

Impact of Deucravacitinib on Disease Activity in Patients With Psoriatic Arthritis (PsA): Results From the Pivotal Phase 3 PsA Studies (ACR Convergence 2025) - P3 | "We report deucravacitinib efficacy based on composite measures of disease activity in pts from the POETYK PsA studies. Pts in the POETYK PsA-1 and PsA-2 studies were randomized to deucravacitinib 6 mg once daily or PBO for 16 weeks (in PsA-2, a group received apremilast as a safety reference arm). In these analyses of the pivotal POETYK PsA-1 and PsA-2 phase 3 studies, deucravacitinib substantially reduced disease activity vs PBO at W16 in several composite measures of disease activity, and a significantly higher proportion of pts reached optimal control of disease activity, which aligns with the results from the primary analyses.2,3 Given that remission and low disease activity are primary goals of PsA treatment, deucravacitinib may be an efficacious treatment choice for pts with active PsA."

Clinical • P3 data • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TYK2

To Hold or Not to Hold: Variability in Management of DMARDs in the Setting of Acute Infections - A Survey of Rheumatologists (ACR Convergence 2025) - "DMARDs were grouped by immunosuppressive risk, from lowest to highest: 1) hydroxychloroquine (HCQ) and apremilast, 2) conventional synthetic DMARDs (csDMARDs: azathioprine, leflunomide, methotrexate, mycophenolate mofetil, sulfasalazine), and 3) biologic DMARDs (bDMARDs) including Janus kinase (JAK) inhibitors. There is substantial variability among US rheumatologists in the management of DMARDs during acute infections. These findings highlight a significant knowledge gap and suggests that development of guidelines on this topic would help inform clinical decision-making and standardize care."

Infectious Disease • Rheumatology

Factors impacting progression from oligoarticular to polyarticular PsA: Data from the FOREMOST study (ACR Convergence 2025) - P4 | "Our aim was to analyse progression to polyarticular (poly; >4 active joints) disease and predictors of progression in FOREMOST. FOREMOST is a randomized trial of 308 patients with early (duration ≤5 years) oligo PsA and limited joint involvement ( >1 to ≤4 swollen and >1 to ≤4 tender joints; 66–68 joints assessed) who received apremilast (APR) (n=203) or placebo (PBO) (n=105) for 24 weeks, with a primary outcome at 16 weeks1... Our data provides novel insights into factors driving progression from oligo to poly PsA, with female sex, enthesitis and dactylitis found to increase the risk of progression. These data may help clinicians identify patients with poor prognosis who require close monitoring and more intensive treatment. Among patients in FOREMOST receiving PBO, prior csDMARD use decreased the likelihood of progression more than three-fold."

Dermatology • Immunology • Psoriasis

Effects of Apremilast on Body Mass Index, Weight, and HbA1c as Cardiometabolic Outcomes in Patients With Early Oligoarticular Psoriatic Arthritis in the FOREMOST Study (ACR Convergence 2025) - P4 | "APR treatment through Week 48 was associated with improvements in BMI and weight in the FOREMOST study of early oligo PsA. Consistent with prior studies of APR in polyarticular PsA and psoriasis, greater changes in cardiometabolic markers were observed in patients in the highest risk categories (ie, obesity and diabetic subgroups)."

Clinical • Cardiovascular • Dermatology • Genetic Disorders • Immunology • Inflammatory Arthritis • Metabolic Disorders • Obesity • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Combination of Biological and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Psoriatic Arthritis: A Case-Series (ACR Convergence 2025) - "Combinations with Apremilast (APR) were analyzed for safety...One patient experienced two mild upper respiratory infections (URIs) on bimekizumab and deucravacitinib, prompting a switch for risankizumab with deucravacitinib... Overall, the safety profile of bDMARD combinations with tsDMARDs was favorable. Infections, primarily URIs, were the most common AEs – mild in severity, non-hospitalized, and rarely requiring treatment change. Short-term improvements were observed in both musculoskeletal and skin domains."

Clinical • Dental Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Diseases • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Stomatitis • IL12A