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PloS One 2024To evaluate the impact of the entry of biosimilars on the pricing of eight biologic products in 57 countries and regions.
OBJECTIVE
To evaluate the impact of the entry of biosimilars on the pricing of eight biologic products in 57 countries and regions.
METHODS
We utilized an interrupted time series design and IQVIA MIDAS® data to analyze the annual sales data of eight biologic products (adalimumab, bevacizumab, epoetin, etanercept, filgrastim, infliximab, pegfilgrastim, and trastuzumab) across 57 countries and regions from January 1, 2012, to December 31, 2019. We examined the immediate and long-term changes in biologics ex-manufacturer pricing following the entry of biosimilars to the market.
RESULTS
Following the entry of biosimilars, the average price per dose of biologic product was immediately reduced by $438 for trastuzumab, $112 for infliximab, and $110 for bevacizumab. The persistent effect of biosimilars' market entry led to further reductions in price per dose every year: by $49 for adalimumab, $290 for filgrastim, $21 for infliximab, and $189 for trastuzumab. Similarly, we analyzed the impact of biosimilars on four biologics' prices in the US, where the prices of three biologics significantly decreased every year, with filgrastim, pegfilgrastim, and infliximab decreasing by $955, $753, and $104, respectively.
CONCLUSIONS
The introduction of biosimilars has significantly reduced the prices of biologics both globally and in the US. These findings not only demonstrate the economic benefits of increasing biosimilar utilization, but also emphasize the importance of biosimilars in controlling healthcare costs. Policies should aim to expand the availability of biosimilars to counteract the exponential growth of medical spending caused by the use of biologics.
Topics: Biosimilar Pharmaceuticals; Humans; Infliximab; Filgrastim; Biological Products; Drug Costs; Adalimumab; Etanercept; Trastuzumab; Costs and Cost Analysis; Polyethylene Glycols
PubMed: 38843282
DOI: 10.1371/journal.pone.0304851 -
JAMA Jul 2024
Topics: United States; Medicare Part D; Biosimilar Pharmaceuticals; Adalimumab; Humans; Insurance Coverage; Formularies as Topic; Drugs, Generic
PubMed: 38842823
DOI: 10.1001/jama.2024.8917 -
Ocular Immunology and Inflammation Jun 2024Papillophlebitis is a rare condition, manifesting as CRVO in the young adults. We aim to present our experience in managing patients with papillophlebitis. (Review)
Review
PURPOSE
Papillophlebitis is a rare condition, manifesting as CRVO in the young adults. We aim to present our experience in managing patients with papillophlebitis.
METHODS
Retrospective review of patients' medical files.
RESULTS
Included were seven patients with a mean presenting age of 24.86 ± 4.4 years and mean follow-up of 40.4 ± 50.5 months. No pre-existing systemic illness was reported by any patient. One patient was subsequently diagnosed to have Behçet disease and another patient was diagnosed with homozygous mutation to MTHFR C6771. On presentation, fluorescein angiograms showed diffuse vascular and optic disc leakage. Four patients presented with papillophlebitis-associated CME, for which they were treated with systemic steroids and intravitreal anti-VEGF injections. One patient showed full recovery. In 3 patients, due to the protracted course of papillophlebitis and refractory CME, adalimumab was added. All 3 patients eventually showed complete resolution of CME. Two of them eventually developed extensive peripheral capillary non-perfusion that was treated with panretinal photocoagulation. Three patients did not develop CME: In two patients, papillophlebitis resolved after a short course of prednisone while in the third patient, papillophlebitis resolved spontaneously. Mean ± SD presenting log MAR VA was 0.2 ± 0.32 and it was 0.057 ± 0.11 at the last follow-up.
CONCLUSION
To the best of our knowledge, this is the first description that suggests a role for TNF-ɑ blockers in the management of patients with recalcitrant papillophlebitis and non-responsive CME. Further studies are needed in order to thoroughly investigate the molecular background of papillophlebitis and clinical outcomes associated with this class of medications.
PubMed: 38842197
DOI: 10.1080/09273948.2024.2359622 -
Indian Journal of Dermatology 2024In recent years, with the increased usage of tumour necrosis factor (TNF) inhibitors, more side effects have been revealed. Paradoxical psoriasis, including psoriasis...
In recent years, with the increased usage of tumour necrosis factor (TNF) inhibitors, more side effects have been revealed. Paradoxical psoriasis, including psoriasis vulgaris, palmoplantar pustulosis, scalp psoriasis and their combinations, is a common adverse effect. However, erythrodermic psoriasis associated with alopecia due to anti-TNF-α is rarely reported in the literature. We report a 44-year-old woman who developed erythrodermic psoriasis associated with diffuse alopecia during her treatment with adalimumab for palmoplantar pustulosis.
PubMed: 38841217
DOI: 10.4103/ijd.ijd_155_23 -
Skin Appendage Disorders Jun 2024Dissecting cellulitis of the scalp (DCS) is a neutrophilic scarring alopecia typically presenting with pustules and fluctuant nodules, followed by suppuration and sinus...
INTRODUCTION
Dissecting cellulitis of the scalp (DCS) is a neutrophilic scarring alopecia typically presenting with pustules and fluctuant nodules, followed by suppuration and sinus tract formation. DCS is often associated with other diseases, such as hidradenitis suppurativa (HS) and conglobate acne (CA) which share similar pathogenetic mechanisms.
CASE PRESENTATION
The authors report the case of a patient affected by a severe form of DCS, HS, and CA of the face. Previous treatments with isotretinoin, antibiotics, and adalimumab did not have a considerable efficacy. Off-label treatment with secukinumab showed a gradual improvement in the clinical presentation bringing to a reduction in the number of HS lesions and to an almost complete resolution of the inflammatory manifestations of DCS.
CONCLUSION
Management of DCS is challenging and is typically based on retinoids which are considered the first line of treatment. The efficacy of biologic drugs, especially TNFα inhibitors, in severe and relapsing forms of DCS has been reported in recent literature. To our knowledge, only one case of isolated DCS treated with secukinumab is reported. No cases of concomitant DCS and HS, treated with this type of IL-17 inhibitor, have been described.
PubMed: 38835714
DOI: 10.1159/000537914 -
Cureus Jun 2024Ulcerative colitis (UC) is an inflammatory disorder affecting the colon, and typically, during the disease course, the condition may exacerbate, relapse, and remit. One... (Review)
Review
Ulcerative colitis (UC) is an inflammatory disorder affecting the colon, and typically, during the disease course, the condition may exacerbate, relapse, and remit. One of the most successful lines for inducing and maintaining clinical remission in subjects with UC is biological therapy with anti-tumor necrosis factor α (anti-TNF) agents, including adalimumab (ADA) and infliximab (IFX). This meta-analysis is an attempt to obtain complementary information driven by real-world experience (RWE) concerning the efficacy and safety of two of the most popular anti-TNFs in treating UC. This is a systematic review and meta-analysis of RWE studies comparing ADA and IFX as naïve anti-TNF agents for the treatment of subjects with UC. Studies were obtained by searching Scopus, Google Scholar, the Cochrane Central Register of Controlled Trials, Embase, and the PubMed Central databases. Patients treated with IFX showed significantly higher induction responses. No statistically significant difference was found in the comparison of response in the maintenance treatment period. Higher overall adverse events were related to IFX treatment, with serious adverse events that were nonsignificantly higher in the ADA-treated group. In conclusion, IFX demonstrated significantly higher induction responses compared to ADA in patients with moderate-to-severe UC. IFX was associated with higher overall adverse events, whereas serious adverse events were non-significantly higher in the ADA-treated group. IFX may be favored as a first-line agent for its induction efficacy, and the choice between IFX and ADA should be individualized based on comprehensive clinical evaluation.
PubMed: 38835557
DOI: 10.7759/cureus.61547 -
Clinical, Cosmetic and Investigational... 2024This case study outlines the management of a 24-year-old male with a history of juvenile nephronophthisis who underwent renal transplantation at age 12 and later...
This case study outlines the management of a 24-year-old male with a history of juvenile nephronophthisis who underwent renal transplantation at age 12 and later required dialysis at 18 due to chronic rejection and hypertension. Subsequently, the patient developed severe Hidradenitis Suppurativa (HS) affecting the axillary, groin, and gluteal regions. Despite undergoing various systemic and intravenous antibiotic therapies, as well as Adalimumab treatment, the HS remained refractory. Adalimumab was discontinued due to a detected ejection fraction of 45% during cardiologic follow-up, likely due to COVID-19 related myocarditis. Following this, the patient was initiated on secukinumab therapy, initially undergoing an induction phase followed by maintenance dosing. Significant improvements were observed in quality of life, pain scores, and HS activity after 5 weeks of secukinumab therapy, with sustained benefits at the 6-month follow-up. Secukinumab was well tolerated, with no reported adverse events. This case underscores the effectiveness and safety of secukinumab as a therapeutic option for refractory HS, particularly in patients with comorbidities such as renal transplant recipients.
PubMed: 38831783
DOI: 10.2147/CCID.S468268 -
Zeitschrift Fur Rheumatologie Jun 2024Head-to-head studies are important to select the optimal treatment in terms of efficacy and side effect profiles when several drugs are available. (Review)
Review
BACKGROUND
Head-to-head studies are important to select the optimal treatment in terms of efficacy and side effect profiles when several drugs are available.
AIM OF THE WORK
This article describes all studies comparing the use of disease-modifying antirheumatic drugs (DMARD) in rheumatoid arthritis (RA) in head-to-head studies or in which a DMARD was at least included in an active comparison arm.
RESULTS
A total of 23 studies comparing DMARDs were identified. These included comparisons of Janus kinase (JAK) inhibitors with methotrexate and with adalimumab as well as the oral surveillance study.
DISCUSSION
There are already an exceptionally large number of head-to-head studies in RA, both for comparisons of efficacy and safety of DMARDs. Nevertheless, more such comparative studies are needed, for example to clarify whether adverse events of tofacitinib observed in the oral surveillance study are specific to the JAK 1/JAK 3 inhibitor or are a class effect of all JAK inhibitors.
PubMed: 38831141
DOI: 10.1007/s00393-024-01517-8 -
Ocular Immunology and Inflammation Jun 2024To investigate the long-term efficacy and safety of adalimumab(ADA) in the treatment of patients with serpiginous choroiditis (SC) refractory to conventional therapy...
BACKGROUND/OBJECTIVES
To investigate the long-term efficacy and safety of adalimumab(ADA) in the treatment of patients with serpiginous choroiditis (SC) refractory to conventional therapy through quantitative parameters.
SUBJECTS/METHODS
A retrospective analysis was conducted on patients diagnosed with SC clinically and through fundus autofluorescence(FAF). Patients receiving ADA treatment were included. Demographic and clinical characteristics of the patients, association with tuberculosis (TB) infection, number of immunosuppressive therapies, recurrences, best corrected visual acuity (BCVA) change, and ADA-related side effects were recorded. The progression rate before and after ADA was calculated based on the area involved by FAF.
RESULTS
Sixteen eyes of 8 patients (3 female/5 male) were enrolled to the study. The median (IQR) age was 53.5 (16.5) years. Diagnosis was SC in 4, ampiginous choroiditis in 3, and TB-related serpiginous-like choroiditis in 1 patient. Peripapillary involvement was present in 10 of 16 eyes. The area involved by FAF continued to progress under ADA treatment, however the progression rate was decreased ( = 0.143).The BCVA was preserved ( = 0.772). The number of systemic and local treatments decreased with ADA ( = 0.025 and 0.019, respectively). Additionally, the number of recurrences was reduced with ADA ( = 0.002). Median (IQR) follow-up was 45(28.75) months. Two patients experienced ADA-related side effects (pulmonary TBand rash).
CONCLUSIONS
Our findings suggest a promising role for ADA in halting the progression of SC and have implications for improving outcomes. Despite the evidence in the literature at the level of case reports, ADA can be used effectively with close monitoring for potential risks.
PubMed: 38829969
DOI: 10.1080/09273948.2024.2359002 -
Therapeutic Advances in Gastroenterology 2024Anti-tumor necrosis factor (TNF) monoclonal antibodies, especially infliximab (IFX) and adalimumab (ADA), are considered the first-line treatment for active Crohn's...
Development and validation of a novel therapeutic drug monitoring-based nomogram for prediction of primary endoscopic response to anti-TNF therapy in active Crohn's disease.
BACKGROUND
Anti-tumor necrosis factor (TNF) monoclonal antibodies, especially infliximab (IFX) and adalimumab (ADA), are considered the first-line treatment for active Crohn's disease (CD). However, the predictive role of therapeutic drug monitoring (TDM) of serum anti-TNF in monitoring the treatment of inflammatory bowel disease (IBD) remains controversial.
OBJECTIVES
To explore the correlation between serum anti-TNF levels and early endoscopic response in active CD using a TDM-based nomogram.
DESIGN
Cross-sectional study.
METHODS
The simplified endoscopic activity score for CD (SES-CD), Crohn's disease activity index (CDAI), laboratory parameters, and the serum trough levels of IFX and ADA were assessed.
RESULTS
The trough levels of IFX or ADA were significantly higher in patients with endoscopic response compared to non-responders in the development cohort ( < 0.001). The IFX and ADA levels showed a weak but significantly negative correlation with SES-CD ( < 0.001), CDAI ( < 0.001), and C-reactive protein (CRP) ( < 0.001) at week 14 post-IFX therapy in the development cohort. Furthermore, the receiver operating characteristic curve revealed that an optimal level of IFX (4.80 μg/mL) and ADA (8.80 μg/mL) exhibited the best performance in predicting endoscopic response. Concomitantly, we developed a novel nomogram prediction model based on the results of multivariate logistic regression analysis, which consisted of CRP, albumin (Alb), and anti-TNF trough levels at week 14. The nomogram showed significant discrimination and calibration for both IFX and ADA in the development cohort and performed well in the external validation cohort.
CONCLUSION
This study demonstrates a robust association between serum concentrations of IFX, ADA, Alb, and CRP and primary endoscopic response in active CD patients. Importantly, the TDM- and laboratory marker-based nomogram may be used to evaluate the primary endoscopic response to anti-TNF therapy, especially for optimizing treatment strategies and switching therapy in CD patients.
PubMed: 38827646
DOI: 10.1177/17562848241256237