apremilast / Generic mfg. - LARVOL DELTA

Adverse Events Associated with Apremilast and Deucravacitinib for Psoriasis: A Pharmacovigilance Study Based on the FAERS Database. (PubMed, Clin Cosmet Investig Dermatol) - "Our study offers valuable real-world insights into the safety profiles of apremilast and deucravacitinib. The observed sex differences in adverse events associated with apremilast and deucravacitinib require further investigation in real-world and clinical settings."

Adverse events • Journal • Acne Vulgaris • Allergy • Dermatitis • Dermatology • Immunology • Pain • Pruritus • Psoriasis • Rosacea

Apremilast Coadministered with Secukinumab for Effective Treatment of Acrodermatitis Continua of Hallopeau: A Case Report. (PubMed, Clin Cosmet Investig Dermatol) - "During the 2 years of treatment, laboratory workup was within normal limits. This case underscores that the combination therapy of secukinumab and apremilast can offer a promising approach for the long-term management of ACH."

Journal • Dermatitis • Dermatology • Immunology • Pain • Psoriasis • Pustular Psoriasis

Management of treatment-resistant acquired perforating dermatosis with apremilast: A novel therapeutic approach. (PubMed, JAAD Case Rep) - No abstract available

Journal • Chronic Kidney Disease • Dermatology • Diabetes • Diabetic Nephropathy • Inflammation • Metabolic Disorders • Nephrology • Pruritus • Renal Disease

Clinical Characteristics and Safety Profiles of Japanese Psoriasis Patients Who Continued Apremilast Treatment for 6 and 12 Months: A Post Hoc Analysis of an Apremilast Postmarketing Surveillance Study. (PubMed, J Dermatol) - "In 509 patients who continued apremilast for 12 months, diarrhea was reported in 43 patients (8.5%), nausea in 24 patients (4.7%), and headache in 6 (1.2%) patients; similar frequencies of these adverse reactions were observed within 6 months and between 6 and 12 months of follow-up. It is important to continue apremilast by appropriately managing diarrhea and nausea in real-world practice."

Journal • P4 data • Retrospective data • Dermatology • Immunology • Pain • Psoriasis

The efficacy of apremilast in pemphigus: a systematic review of case reports. (PubMed, Dermatol Reports) - "Although the evidence is limited, it supports apremilast's efficacy and favorable safety profile. Further research with larger sample sizes and randomized controlled trials is necessary to confirm these findings."

Journal • Dermatology • Dermatopathology • Immunology • Infectious Disease

PALI-2108, A COLON-SPECIFIC PDE4 INHIBITOR PRODRUG, IS BIOACTIVATED IN THE COLON AND REDUCES COLON TISSUE PDE4B IN A DOSE-DEPENDENT MANNER, INCREASING C-AMP AND SUPPRESSING TNF-Α IN A MOUSE MODEL OF COLITIS (DDW 2025) - "Interestingly the elevation of cAMP levels leads to a reduction of cytokine TNF-α levels close to normal levels associated with reduced levels of inflammation in the PALI-2108 treatment cohorts, Cyclosporin A or apremilast treatment did not lower TNFa levels as much as PALI-2108 treatment (see Figure 2)... PALI-2108 is a colon-specific PDE4 inhibitor for the treatment of UC and other inflammatory bowel diseases (IBD). By preventing the degradation of intracellular cAMP, PALI-2108 modulates downstream pro-inflammatory factors and promotes anti-inflammatory cytokines within the lamina propria. Our preclinical data demonstrate that PALI-2108 effectively reduces colitis symptoms in a dose-dependent manner, supporting its potential as a viable alternative for treating UC."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • TNFA

A BIOINFORMATIC APPROACH TO PALI-2108 TREATMENT IN ULCERATIVE COLITIS REVEALS THE POTENTIAL FOR ANTI-FIBROTIC EFFICACY WITH LOCAL PDE4 INHIBITION IN INTESTINAL FIBROSIS (DDW 2025) - " We identified cAMP-regulated signatures that demonstrated ~100% sensitivity and 70% specificity for predicting infliximab response in UC patients in silico...Fig 2: Fibrotic Pathway Expression Score for cohorts treated with, apremilast and PALI-2108 in a DSS mouse model of colitis... Our findings suggest that cAMP-regulated drivers of inflammation are activated in both UC and fibrostenotic CD. Therapy leading to a reduction of cAMP regulated inflammation could offer new treatment options for patients. PALI-2108's potential to engage antifibrotic pathways may provide a novel therapy to treat fibrostenotic CD."

Clinical • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Apremilast Reduces MRI Inflammation in Individual Joints and Clinical Dactylitis in Patients With Psoriatic Arthritis: Dynamic Contrast-Enhanced MRI (DCE-MRI) Results From the Phase 4 MOSAIC Study (EULAR 2025) - No abstract available

Clinical • P4 data • Immunology • Inflammation • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Systemic and Tissue-Specific Molecular Profiling of Apremilast in Hepatic Steatosis: A Potential Therapeutic for MASLD in PsA (EULAR 2025) - No abstract available

Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

APREMILAST IN THE TREATMENT OF REFRACTORY MUCOSAL BEHÇET'S SYNDROME AND ITS POTENTIAL MOLECULAR MECHANISMS (EULAR 2025) - No abstract available

Rare Diseases

Apremilast Improves Patient-reported Pain Regardless of Sex and Age in Early Oligoarticular Psoriatic Arthritis: A Post-hoc Analysis From FOREMOST (EULAR 2025) - No abstract available

Clinical • Retrospective data • Immunology • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Use of Apremilast for the Treatment of Immune Checkpoint Inhibitor-Induced Psoriasis and Psoriatic Arthritis (EULAR 2025) - No abstract available

Checkpoint inhibition • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Product Sales Performance (PRNewswire) - "Otezla (apremilast) sales increased 11% year-over-year to $437 million in the first quarter, driven by 12% favorable changes to estimated sales deductions, as volume growth of 4% was offset by 5% lower net selling price; Enbrel (etanercept) sales decreased 10% year-over-year to $510 million in the first quarter, driven by 47% lower net selling price resulting from increased 340B Program mix and higher commercial discounts, partially offset by 19% favorable changes to estimated sales deductions, higher inventory levels and volume growth...AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales decreased 19% year-over-year to $136 million in the first quarter, primarily driven by 33% lower net selling price, partially offset by 11% volume growth; WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $150 million of sales in the first quarter. WEZLANA launched in the U.S. in the first quarter of 2025....PAVBLU (aflibercept-ayyh) generated $99 million of sales in the first quarter."

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

Apremilast: Real-life efficacy and safety in psoriasis limited to the nails. (PubMed, Ann Dermatol Venereol) - "This study shows improvements in nail psoriasis severity and quality of life with apremilast treatment. Despite potential confounders like psoriatic arthritis, smoking, and manual work, consistent improvements were observed. Apremilast appears to be a valuable treatment option for nail psoriasis. However, further prospective studies are necessary to address the limitations of this retrospective analysis and explore additional endpoints."

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

Efficacy and Safety of Apremilast Over 52 Weeks in Patients with Plaque Psoriasis in High-Impact Areas and Impaired Quality of Life. (PubMed, Dermatol Ther (Heidelb)) - P4 | "Improvements in QoL and disease severity at week 16 were maintained through week 52 with continued apremilast treatment in EMBRACE, with no new safety signals. TRIAL REGISTRATION CLINICALTRIALS."

HEOR • Journal • Dermatology • Immunology • Pain • Psoriasis

Vulgar Psoriasis Triggered by Active Pulmonary Tuberculosis: A Case Report and Literature Review Highlighting Immunological Interactions and Genetic Susceptibility. (PubMed, Clin Pract) - " This unique case highlights the shared immune mechanism of these diseases, particularly involving TNF-α, IL-17, and CD4+ T cells. The coexistence of these conditions raises critical questions about the interplay between infectious and autoimmune diseases and the impact of genetic susceptibility."

Journal • Dermatology • Immunology • Infectious Disease • Psoriasis • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • IL17A • TNFA

Increasing biologic and targeted synthetic DMARD use across multiple therapeutic indications in England: a population-level study (BSR 2025) - "We compared trends in monthly issued drug quantities for TNF inhibitors, IL-6 inhibitors, JAK inhibitors, rituximab, abatacept, IL-17 inhibitors, IL-12/23 and IL-23 inhibitors, IL-1 inhibitors, belimumab, apremilast, vedolizumab, IL-5 inhibitors, IL-4 and IL-4/13 inhibitors, and IgE inhibitors. In England, the number of people prescribed targeted therapies has increased by two-thirds during the last 5 years. In 2024, an estimated 0.7% of the population were prescribed targeted therapies used for immune-mediated inflammatory diseases. This growth has been driven primarily by increased prescribing of TNF inhibitors, IL-12/23 and IL-23 inhibitors, and JAK inhibitors."

Clinical • Immunology • Inflammation • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A • IL4 • IL5

Cardiovascular safety of systemic psoriasis treatments: A prospective cohort study in the BIOBADADERM registry. (PubMed, J Eur Acad Dermatol Venereol) - "This real-world evidence study indicates a potential association between APR and IL-17 with a lower incidence of MACE, while CYC showed a higher incidence compared to MTX. These findings underscore the importance of considering cardiovascular outcomes when selecting systemic therapies for patients with psoriasis."

Journal • Cardiovascular • Dermatology • Immunology • Inflammation • Psoriasis • IL12A • IL17A • IL23A

Epac1 contributes to apremilast-mediated rescue of pemphigus autoantibody-induced loss of keratinocyte adhesion. (PubMed, JCI Insight) - "Mechanistically, Epac1 deficiency resulted in lack of apremilast-induced Rap1 activation and phosphorylation of Pg at S665. Taken together, these data indicate that Epac1 is involved in the regulation of baseline and cAMP-mediated stabilization of keratinocyte adhesion."

Journal • Dermatology • Immunology • Pemphigus Vulgaris

Anifrolumab in Refractory Dermatomyositis and Antisynthetase Syndrome. (PubMed, Case Rep Rheumatol) - P3 | "Initial therapies with methotrexate and prednisone were ineffective, and her condition worsened despite adding intravenous immunoglobulin (IVIg) and tofacitinib. Following persistent disease progression, therapy was switched to a combination of IVIg, apremilast, and anifrolumab as an off-label drug for DM...It also highlights the need for further research into the IFN pathway as a therapeutic target in inflammatory myopathies. Trial Registration: ClinicalTrials.gov identifier: NCT06455449."

Journal • Dermatology • Dermatomyositis • Immunology • Inflammation • Myositis • Rare Diseases • IFNAR2

Systemic Janus kinase inhibitors in the management of granuloma annulare. (PubMed, Arch Dermatol Res) - "All patients on oral JAK inhibitor therapy (upadacitinib or abrocitinib) had improvement and/or clearance of their GA lesions within the first three months of therapy...Furthermore, JAK inhibitor therapy resulted in faster clearance time compared to other conventional treatments (e.g., antimicrobials, antimalarials, apremilast, methotrexate, and anti-tumor necrosis factor inhibitors). Depending on extent of GA involvement and patient-provider preferences, oral JAK inhibition therapy can be used off-label. Generally, these medications are well tolerated with few side effects compared to other GA treatment options."

Journal • Retrospective data • Acne Vulgaris • Infectious Disease • Oncology • Rare Diseases

Retrospective Real-World Study Assessing Treatment Patterns of Adult Patients with Moderate-to-Severe Psoriasis in the United States Initiating Advanced Therapies and Their Dispositions (ISPOR 2025) - "Several advanced therapies (ATs) including tumor necrosis factor (TNF) inhibitors, interleukin (IL) inhibitors (e.g., IL-12/23, IL-23, IL-17), apremilast, deucravacitinib and biosimilars of TNF-inhibitors and IL-12/23 inhibitors are indicated for the treatment of moderate-to-severe PsO in the US. Originator biologics and especially TNF-inhibitors originators were the predominant treatment choice for first-line moderate-to-severe psoriasis therapy. Half of the patients remained on first-line therapy for 8.5 months. The use of biosimilars was limited."

Metastases • Real-world • Real-world evidence • Retrospective data • Cardiovascular • Dermatology • Hypertension • Immunology • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A

Patient-Reported Outcomes As Important Predictors of Apremilast Persistence: A Pooled Analysis of Real-World Data (ISPOR 2025) - "Patient-reported global treatment satisfaction was significantly associated with 6-month apremilast persistence. Understanding patient-perceived satisfaction and benefits throughout the treatment journey is integral to ensuring persistence on psoriatic treatments."

Patient reported outcomes • Real-world • Real-world evidence • Retrospective data • Dermatology • Dermatopathology • Immunology • Psoriasis

Real-World Treatment Patterns Among Patients With Scalp Psoriasis in Canada (ISPOR 2025) - "More than half of the patients with scalp psoriasis were treated with an advanced systemic therapy; the three most common were risankizumab (26%), guselkumab (18%), and apremilast (10%). Scalp psoriasis was present in a substantial proportion of patients with plaque psoriasis in Canada, identified in more than one-third of patients in the DERMAID database. Patients with scalp psoriasis are likely to receive advanced systemic therapy, with more than half of the patients having received this treatment. Even when BSA <10% is present, indicative of mild-to-moderate psoriasis that can be managed topically, a sizable proportion of patients (20%) received advanced therapy."

Clinical • HEOR • Real-world • Real-world evidence • Dermatology • Immunology • Psoriasis

Topical Crisaborole for the Treatment of Recalcitrant Palmoplantar Pustulosis: A Case Series. (PubMed, Dermatol Ther (Heidelb)) - "The positive response of topical crisaborole observed in our cases also echoes the efficacy of apremilast, a systemic phosphodiesterase 4 (PDE4) inhibitor which successfully treated PPP in other reports, highlighting the potential role of PDE4 in the pathophysiology of PPP. Further studies are needed for a more comprehensive evaluation."

Journal • Immunology • Psoriasis