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BMJ Open Jul 2023Psoriasis is a chronic inflammatory skin disease. Adalimumab is an effective but previously expensive biological treatment for psoriasis. The introduction of biosimilars...
INTRODUCTION
Psoriasis is a chronic inflammatory skin disease. Adalimumab is an effective but previously expensive biological treatment for psoriasis. The introduction of biosimilars following the patent expiry of the originator adalimumab Humira has reduced the unit cost of treatment. However, the long-term effectiveness and safety of adalimumab biosimilars for treating psoriasis in real-world settings are uncertain and may be a barrier to widespread usage.
METHODS AND ANALYSIS
This study aims to compare the drug survival and safety of adalimumab biosimilars to adalimumab originator for the treatment of psoriasis. We will use both routinely collected healthcare databases and dedicated pharmacovigilance registries from the PsoNet initiative, including data from the UK, France and Spain. We will conduct a cohort study using a prevalent new user design. We will match patients on previous adalimumab exposure time to create two equal-sized cohorts of biosimilar and originator users. The coprimary outcomes are drug survival, defined by the time from cohort entry to discontinuation of the drug of interest; and risk of serious adverse events, defined by adverse events leading to hospitalisation or death. Cox proportional hazards models will be fitted to calculate HRs as the effect estimate for the outcomes.
ETHICS AND DISSEMINATION
The participating registries agree with the Declaration of Helsinki and received approval from local ethics committees. The results of the study will be published in scientific journals and presented at international dermatology conferences by the end of 2023.
Topics: Humans; Adalimumab; Biosimilar Pharmaceuticals; Cohort Studies; Psoriasis; Dermatitis; Treatment Outcome
PubMed: 37451726
DOI: 10.1136/bmjopen-2023-075197 -
Expert Opinion on Biological Therapy 2023Biosimilar adalimumabs have improved treatment access, but without any clinical advantage, distributors rely on delivery device design-enhancements, support services,... (Review)
Review
BACKGROUND
Biosimilar adalimumabs have improved treatment access, but without any clinical advantage, distributors rely on delivery device design-enhancements, support services, and removal of painful excipients to capture market share. Prescribers, however, are often unaware of these differences. This article compares and contrasts originator versus biosimilar adalimumab agents to identify key differences that might influence adalimumab selection.
RESEARCH DESIGN AND METHODS
We reviewed listed adalimumab biosimilars in Australia and compared them to the originator adalimumab. Similarities and differences identified were confirmed with the manufacturers via two rounds of interviews: the first to collate a list of features and benefits of their product, and the second to consolidate and confirm the data.
RESULTS
The originator adalimumab Humira [by AbbVie, U.S.A] and four adalimumab biosimilars (Amgevita [by Amgen, U.S.A], Hadlima [by Organon, U.S.A], Hyrimoz [by Sandoz, Switzerland], and Idacio [by Fresenius Kabi, Germany]) are included in this review. Key differences identified include product formulation, dosages available, delivery devices, physician support, patient support, and the supply of other biosimilar products by the company.
CONCLUSION
Adalimumab biosimilars are different from each other with unique advantages and disadvantages likely to influence prescriber and patients. Therefore, the choice of agent should be individualized to the needs of the patient and the healthcare service.
Topics: Humans; Adalimumab; Biosimilar Pharmaceuticals; Inflammatory Bowel Diseases; Australia
PubMed: 37070385
DOI: 10.1080/14712598.2023.2203812 -
Journal of Drugs in Dermatology : JDD Aug 2017
Psoriasis is a common, inflammatory disease that manifests itself as lesions on the skin, which greatly impacts the physical and psychological wellbeing of those... (Review)
Review
Psoriasis is a common, inflammatory disease that manifests itself as lesions on the skin, which greatly impacts the physical and psychological wellbeing of those affected. The current goal of treatment in psoriasis is to improve the signs and symptoms of disease, whilst minimizing the burden of disease on patient health-related quality of life. Psoriasis can also be associated with other comorbidities such as joint disease, cardiovascular disease, and depression, which can add to the complexity of treatment.
Adalimumab is a recombinant, fully human, monoclonal antibody against tumor necrosis factor alpha (TNF-α), which blocks the interaction of TNF with both of its cell-surface receptors, with high affinity and specificity. Adalimumab is well established for the treatment of moderate-severe chronic plaque psoriasis in adults, and has more recently been approved in the European Union for use in pediatric patients with severe chronic plaque psoriasis.
Here we provide a clinical guide for adalimumab and review existing data on the efficacy and safety of originator adalimumab in moderate-severe chronic plaque psoriasis in adult and pediatric patients. We discuss short- and long-term treatment with adalimumab, and efficacy in hard-to-treat psoriasis of the scalp, hands, feet, and nails, in addition to the impact on associated pain and pruritus. We also discuss treatment optimization with adalimumab in the context of relevant clinical scenarios, and treatment of complex patients with underlying comorbidities. Finally, we examine available real-world clinical data for adalimumab in psoriasis.
J Drugs Dermatol. 2017;16(8):779-790.
.Topics: Adalimumab; Anti-Inflammatory Agents; Chronic Disease; Humans; Practice Guidelines as Topic; Psoriasis
PubMed: 28809993
DOI: No ID Found -
Expert Review of Clinical Immunology May 2024Hidradenitis suppurativa (HS) is an autoinflammatory skin disease with a high unmet need for effective medical management. Clinically, it is characterized by... (Review)
Review
INTRODUCTION
Hidradenitis suppurativa (HS) is an autoinflammatory skin disease with a high unmet need for effective medical management. Clinically, it is characterized by inflammatory nodules that may progress into abscesses, draining tunnels and extensive scarring, mainly affecting apocrine gland-bearing areas.
AREAS COVERED
Treatment options include topical and systemic medications and a variety of surgical procedures. The anti-TNF-α antibody adalimumab and the anti-IL-17 secukinumab are the only two approved biologics for HS, showing moderate efficacy. HS research is a rapidly growing field, with a wide range of agents leveraging distinct mechanisms of action currently under development. Drugs targeting the IL-17 and Janus kinase/signal transducer and activator of transcription (JAK/STAT) pathways are the most advanced in both ongoing and completed Phase 3 studies, promising deeper levels of response. Use of other, off-label biologics is also discussed.
EXPERT OPINION
A therapeutic algorithm is proposed based on comorbidities and existing evidence. Patient-tailored combinations between biologics and other biologics or small molecules will hopefully allow clinicians to target most events in HS pathophysiology in a complementary way while obtaining a meaningful effect on their devastating manifestations.
Topics: Humans; Hidradenitis Suppurativa; Biological Products; Tumor Necrosis Factor Inhibitors; Adalimumab; Biological Factors
PubMed: 38130204
DOI: 10.1080/1744666X.2023.2298356 -
Advances in Therapy Oct 2023This study evaluated 12 months adherence and persistence among Janus kinase inhibitors (upadacitinib, baricitinib, tofacitinib) and adalimumab, a tumor necrosis factor...
One-Year Medication Adherence and Persistence in Rheumatoid Arthritis in Clinical Practice: A Retrospective Analysis of Upadacitinib, Adalimumab, Baricitinib, and Tofacitinib.
INTRODUCTION
This study evaluated 12 months adherence and persistence among Janus kinase inhibitors (upadacitinib, baricitinib, tofacitinib) and adalimumab, a tumor necrosis factor inhibitor (TNFi), in patients with rheumatoid arthritis (RA).
METHODS
This retrospective analysis used administrative claims data from the Merative™ MarketScan Research Databases (2018-2022). Eligible adults had ≥ 1 RA diagnosis before the index date, ≥ 1 pharmacy claim for index medication, and ≥ 12 months of continuous insurance enrollment pre- and post-index. Adherence to treatment [defined as proportion of days covered (PDC) ≥ 80%], risk of treatment discontinuation, and mean time to discontinuation were assessed during the 12 months follow-up. Adjusted odds ratios (aOR), adjusted hazard ratios (aHR), and 95% confidence intervals (CI) were reported.
RESULTS
In total, 6317 patients were included (683 upadacitinib, 3732 adalimumab, 132 baricitinib, 1770 tofacitinib). Compared with upadacitinib, patients initiating adalimumab [aOR (95% CI): 0.82 (0.69, 0.96)], baricitinib [0.46 (0.31, 0.68)], and tofacitinib [0.74 (0.62, 0.88)] were significantly less likely to achieve PDC ≥ 80%. Risk of treatment discontinuation was significantly higher in patients treated with adalimumab [aHR (95% CI): 1.14 (1.01, 1.29)], baricitinib [1.48 (1.16, 1.90)], and tofacitinib [1.22 (1.07, 1.38)] compared with upadacitinib. Mean time to discontinuation was 256 (upadacitinib), 249 (adalimumab), 221 (baricitinib), and 239 (tofacitinib) days. Similar results were observed in patients with prior TNFi use.
CONCLUSIONS
Patients with RA, regardless of recent TNFi experience, initiating upadacitinib were significantly more likely to be adherent and less likely to discontinue therapy compared to adalimumab, baricitinib, and tofacitinib in the first 12 months of treatment.
Topics: Adult; Humans; Adalimumab; Antirheumatic Agents; Retrospective Studies; Arthritis, Rheumatoid; Medication Adherence
PubMed: 37542646
DOI: 10.1007/s12325-023-02619-6 -
American Journal of Clinical Dermatology Oct 2016Subcutaneous adalimumab (Humira) is a tumour necrosis factor-α blocker that is the only approved agent for the treatment of moderate to severe hidradenitis suppurativa... (Review)
Review
Subcutaneous adalimumab (Humira) is a tumour necrosis factor-α blocker that is the only approved agent for the treatment of moderate to severe hidradenitis suppurativa (HS) in several countries worldwide. This article reviews the clinical efficacy and safety of subcutaneous adalimumab in patients with moderate to severe HS. In clinical trials (PIONEER I and II), a greater proportion of adalimumab than placebo recipients reached HS clinical response (HiSCR) at week 12. The main secondary endpoints, such as the proportion of patients with an abscess and inflammatory nodule count of ≤2 at week 12, were significantly greater with adalimumab than with placebo in PIONEER II, but not in PIONEER I. In addition, adalimumab showed the potential to reduce the high health-related quality of life burden of HS and increase patient satisfaction. HiSCR rates were generally maintained in the longer term, and the safety profile of adalimumab in patients with moderate to severe HS was consistent with the known safety profile of the drug for other indications, with no new emerging safety signals. Adalimumab is an effective and generally well tolerated treatment for patients with moderate to severe HS, and is the first agent approved for this difficult-to-treat disease.
Topics: Adalimumab; Anti-Inflammatory Agents; Hidradenitis Suppurativa; Humans; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome; Tumor Necrosis Factor-alpha
PubMed: 27665300
DOI: 10.1007/s40257-016-0220-6 -
Expert Opinion on Pharmacotherapy Dec 2019: Crohn's disease (CD) is a chronic inflammatory condition that can occur throughout the gastrointestinal tract. The aims of treatment of children with CD are to induce... (Review)
Review
: Crohn's disease (CD) is a chronic inflammatory condition that can occur throughout the gastrointestinal tract. The aims of treatment of children with CD are to induce and maintain clinical remission of disease, optimize nutrition and growth, minimize adverse effects of therapies, and if possible, achieve mucosal healing.: This review summarizes evidence for the various therapeutic options in the treatment of children with CD. Exclusive enteral nutrition, corticosteroids, and biologics may be used for induction of remission. Immunomodulators (thiopurines, methotrexate) and biologics (infliximab, adalimumab) may be employed for maintenance of remission to prevent flares of disease and avoid chronic steroid use. In cases of fibrotic disease, intestinal perforations, or medically refractory, surgery may be the best therapeutic option.: Exclusive enteral nutrition, corticosteroids, and biologics (including anti-TNF inhibitors) may be used for induction of remission in patients with active flare of their disease. Immunomodulators and TNF inhibitors may be used for maintenance of remission. Early use of anti-TNF inhibitors in patients with moderate to severe CD may improve efficacy and prevent penetrating complications of disease. While pediatric data is limited, newer biologics, such as vedolizumab and ustekinumab, are used off-label in anti-TNF refractory disease.
Topics: Adalimumab; Adrenal Cortex Hormones; Child; Clinical Trials as Topic; Crohn Disease; Humans; Immunologic Factors; Infliximab; Remission Induction
PubMed: 31574236
DOI: 10.1080/14656566.2019.1659778 -
American Journal of Therapeutics 2020
Topics: Adalimumab; Hemorrhage; Humans; Pericarditis
PubMed: 31241494
DOI: 10.1097/MJT.0000000000001019 -
International Journal of Molecular... May 2023Hidradenitis suppurativa (HS) is an immune-mediated inflammatory disorder characterized by deep-seated nodules, abscesses, sinus tracts and scars localized in the... (Review)
Review
Hidradenitis suppurativa (HS) is an immune-mediated inflammatory disorder characterized by deep-seated nodules, abscesses, sinus tracts and scars localized in the intertriginous areas. It is accompanied by pain, malodourous secretion and a dramatically decreased quality of life. Although the pathogenesis has not been entirely elucidated, the primary event is follicular hyperkeratosis of the pilosebaceous apocrine unit. Since the registration of the tumor necrosis factor-alpha inhibitor Adalimumab in 2015, several cytokines have been implicated in the pathomechanism of HS and the research of novel therapeutic targets has been intensified. We provide an update on the inflammatory cytokines with a central role in HS pathogenesis and the most promising target molecules of future HS management.
Topics: Humans; Hidradenitis Suppurativa; Quality of Life; Adalimumab; Skin; Cytokines
PubMed: 37176138
DOI: 10.3390/ijms24098428 -
Immunological Medicine Jun 2019Uveitis, which is a major cause of blindness worldwide, is defined as intraocular inflammation that affects the iris, ciliary body, vitreous, retina and choroid. Tumor... (Review)
Review
Uveitis, which is a major cause of blindness worldwide, is defined as intraocular inflammation that affects the iris, ciliary body, vitreous, retina and choroid. Tumor necrosis factor-alpha (TNF-α) is a key cytokine involved in the pathogenesis of many inflammatory diseases including uveitis. Corticosteroids and immunosuppressive agents are the conventional therapy to treat non-infectious uveitis. In cases that are resistant to these therapies, anti-TNF agents are added. An anti-TNF-α agent, adalimumab, was recently approved for the treatment of refractory non-infectious uveitis. In this review, we provide an introduction to uveitis and summarize the effectiveness and safety of adalimumab in the treatment of non-infectious uveitis.
Topics: Adalimumab; Anti-Inflammatory Agents; Behcet Syndrome; Humans; Injections, Subcutaneous; Sarcoidosis; Treatment Outcome; Tumor Necrosis Factor-alpha; Uveitis; Uveomeningoencephalitic Syndrome
PubMed: 31315546
DOI: 10.1080/25785826.2019.1642080