Multidimensional Design and Analysis of a Data Mart Related to Healthcare Treatments with Biologic Drugs

The aim of the study was to assess clinical and economic effectiveness of netakimab compared to other genetically engineered biologic drugs (infliximab, adalimumab, etanercept, ustekinumab, secukinumab, ixekizumab, certolizumab pegol) for the treatment of adult patients with moderate to severe plaque psoriasis. We have conducted cost-benefit analysis, cost-minimisation analysis, and budget impact analysis. We have considered only direct medical costs. The results of the study show that netakimab has higher or comparable efficacy and significantly lower costs compared to other biologic drugs, that makes it the most preferable treatment option for patients with moderate to severe plaque psoriasis. Use of netakimab in clinical practice will significantly reduce budget expenditures and increase patient access to biologic therapy.

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Biologic Drugs for Analgesia: Redefining the Opportunity

Current Pharmaceutical Biotechnology ◽

10.2174/138920111798357384 ◽

2011 ◽

Vol 12 (10) ◽

pp. 1660-1670 ◽

Cited By ~ 1

Author(s):

Jane Hughes ◽

Jonathan P. Hatcher ◽

Iain P. Chessell

Keyword(s):

Biologic Drugs

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Craniectomy with microvascular flap reconstruction in a patient taking infliximab for vasculitis

BMJ Case Reports ◽

10.1136/bcr-2020-238614 ◽

2020 ◽

Vol 13 (12) ◽

pp. e238614

Author(s):

Ogonna N Nnamani Silva ◽

Audrey B Nguyen ◽

William Y Hoffman

Keyword(s):

Diabetes Mellitus ◽

Latissimus Dorsi ◽

Perioperative Management ◽

Large Cell ◽

Evidence Based ◽

Flap Reconstruction ◽

Biologic Drugs ◽

Temporal Arteries ◽

Immune Mediated ◽

Microvascular Flap

For patients whose vasculitis is managed with biologic medications, no reports or evidence-based guidance exists regarding the perioperative management of microvascular flaps. We present a case of a 78-year-old patient with Takayasu’s arteritis (TA) and diabetes mellitus who was taking infliximab and underwent wide local excision of squamous cell carcinoma, craniectomy and reconstruction with a latissimus dorsi flap. TA, an immune-mediated large cell vasculitis characterised by granuloma formation, tends to affect larger vessels and aortic branches. The typical localisation of this condition raises concerns about potentially compromised pedicle and recipient vessels (ie, superficial temporal arteries), which could hinder postoperative flap success. Discontinuation of infliximab 4 weeks before surgery and resumption 6 weeks after led to favourable results. This case addresses the gap in the literature concerning stopping and restarting biologic drugs in the perioperative setting and documents a successful course of a microvascular procedure in a patient with vasculitis.

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POS0675 THE COMPARATIVE 3-YEAR RETENTION RATE OF TARGETED-SYNTHETIC AND BIOLOGIC DRUGS FOR RHEUMATOID ARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN GISEA REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3557 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 582.1-582

Author(s):

E. G. Favalli ◽

F. Iannone ◽

E. Gremese ◽

R. Gorla ◽

R. Foti ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Adverse Events ◽

Retention Rate ◽

Large Population ◽

Real Life ◽

Mechanisms Of Action ◽

Biologic Drugs ◽

Real Life Setting ◽

Study Population ◽

Targeted Drug

Background:Long-term observational data on the real-life use of JAK inhibitors (JAKis) for rheumatoid arthritis (RA) and their comparison with biological drugs are still very limited. Large population-based registries have been increasingly used to investigate the performance of targeted drugs in a real-life setting.Objectives:The aim of this study is to evaluate and compare the 3-year retention rate of JAKis, TNF inhibitors (TNFis) and biologic drugs with other mechanisms of action (OMAs) in the large cohort of RA patients included in the Italian national GISEA registry.Methods:Data of all RA patients treated with targeted synthetic or biologic drugs were prospectively collected in the Italian multicentric GISEA registry. The analysis was limited to patients who started a first- or second-line targeted drug in the period after the first JAKi was marketed in Italy (1st December 2017). The 3-year retention rate was calculated by the Kaplan-Meier method and compared between different drug classes by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 1027 RA patients (79.8% females, mean age [±SD] 56.9 [±13.5] years, mean disease duration 9.8 [±9] years, mean baseline SDAI 17.5 [±11.9], ACPA positive 67.4%, RF positive 62.7%) who received JAKis (baricitinib or tofacitinib, n=297), TNFis (n=365), or OMAs (n=365) as first or second targeted drug. Main baseline characteristics of study population were overall well balanced between treatment groups. Retention rate was numerically but not statistically higher (p=0.18) in patients treated with JAKis compared with TNFis or OMAs (80.6, 78.9 and 76.4% at 1 year and 73, 56.8 and 63.8% at 3 years, respectively) (Figure 1). Drug survival was significantly higher in patients receiving concomitant methotrexate (MTX) compared with monotherapy only in TNFis (66.8 vs 47.1%, p=0.04) but not in JAKis (76.1 vs 70.1%, p=0.54) and OMAs (66.1 vs 61.9%, p=0.41) group. Therapy was discontinued in a total of 211 patients because of ineffectiveness (n=107), adverse events (n=88), or compliance/other reasons (n=16). The most frequent reason for treatment withdrawal was ineffectiveness in both JAKis (n=30 out of 56) and TNFis (n=45 out of 74) groups, whereas OMAs were discontinued more frequently because of adverse events (n=41 out of 81).Conclusion:Our data confirmed in a real-life setting a favorable 3-year retention rate of all available targeted mechanisms of action for RA therapy. As expected, concomitant MTX significantly impacted persistence on therapy of TNFis only. Discontinuations of JAKis for adverse events were infrequent overall, confirming the safety profile observed in randomized clinical trials.Figure 1.Three-year retention rate by treatment groupDisclosure of Interests:None declared

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Impact of immunogenicity on clinical efficacy and toxicity profile of biologic agents used for treatment of inflammatory arthritis in children compared to adults

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x211002685 ◽

2021 ◽

Vol 13 ◽

pp. 1759720X2110026

Author(s):

Chinar R. Parikh ◽

Jaya K. Ponnampalam ◽

George Seligmann ◽

Leda Coelewij ◽

Ines Pineda-Torra ◽

...

Keyword(s):

Side Effects ◽

Clinical Efficacy ◽

Inflammatory Arthritis ◽

Biologic Agents ◽

Adult Patients ◽

Therapeutic Drug ◽

Biologic Drugs ◽

Therapeutic Implications ◽

The Impact ◽

First Time

The treatment of inflammatory arthritis has been revolutionised by the introduction of biologic treatments. Many biologic agents are currently licensed for use in both paediatric and adult patients with inflammatory arthritis and contribute to improved disease outcomes compared with the pre-biologic era. However, immunogenicity to biologic agents, characterised by an immune reaction leading to the production of anti-drug antibodies (ADAs), can negatively impact the therapeutic efficacy of biologic drugs and induce side effects to treatment. This review explores for the first time the impact of immunogenicity against all licensed biologic treatments currently used in inflammatory arthritis across age, and will examine any significant differences between ADA prevalence, titres and timing of development, as well as ADA impact on therapeutic drug levels, clinical efficacy and side effects between paediatric and adult patients. In addition, we will investigate factors associated with differences in immunogenicity across biologic agents used in inflammatory arthritis, and their potential therapeutic implications.

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