scholarly journals Did the Introduction of Biosimilars Influence Their Prices and Utilization? The Case of Biologic Disease Modifying Antirheumatic Drugs (bDMARD) in Bulgaria

2021 ◽  
Vol 14 (1) ◽  
pp. 64
Author(s):  
Konstantin Tachkov ◽  
Zornitsa Mitkova ◽  
Vladimira Boyadzieva ◽  
Guenka Petrova
Keyword(s):  
Joint Disease ◽  
Defined Daily Dose ◽  
Qualitative And Quantitative Analysis ◽  
Inflammatory Joint Disease ◽  
Therapeutic Group ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
National Market ◽  
Daily Dose ◽  
Disease Modifying

The aim of this study is to evaluate the effect of the introduction of biosimilars in Bulgaria on the prices and utilization of biologic disease modifying antirheumatic drugs (bDMARD). It is a combined qualitative and quantitative analysis of time of entry of biosimilars on the national market and the respective changes in the prices and utilization during 2015–2020. We found 58 biosimilars for 16 reference products authorized for sale on the European market by the end of 2019, but for 2 of the reference products biosimilars were not found on the national market. Only inflammatory joint disease had more than one biosimilar molecule indicated for therapy. Prices of the observed bDMARD decreased by 17% down to 48%. We noted significant price decreases upon biosimilar entrance onto the market. In total, the reimbursed expenditures for the whole therapeutic group steadily increased from 72 to 99 million BGN. Utilization changed from to 0.5868 to 2.7215 defined daily dose (DDD)/1000inh/day. Our study shows that the entrance of biosimilars in the country is relatively slow because only half of the biosimilars authorized in Europe are reimbursed nationally. Introduction of biosimilars decreases the prices and changes the utilization significantly but other factors might also contribute to this.

Safety and Effectiveness of 6 Months’ Etanercept Monotherapy and Combination Therapy in Japanese Patients with Rheumatoid Arthritis: Effect of Concomitant Disease-modifying Antirheumatic Drugs

2013 ◽  
Vol 40 (10) ◽  
pp. 1658-1668 ◽  
Author(s):  
Takao Koike ◽  
Masayoshi Harigai ◽  
Shigeko Inokuma ◽  
Naoki Ishiguro ◽  
Junnosuke Ryu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Remission Rate ◽  
Previous Treatment ◽  
Japanese Patients ◽  
Joint Disease ◽  
Concomitant Disease ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Postmarketing Surveillance Study ◽  
Disease Modifying

Objective.To assess real-world safety, tolerability, and effectiveness of etanercept monotherapy, etanercept plus methotrexate (MTX), or etanercept plus other disease-modifying antirheumatic drugs (DMARD) in Japanese patients with active rheumatoid arthritis (RA) despite previous treatment with DMARD.Methods.In this 24-week, all-cases postmarketing surveillance study, adverse events (AE) were coded using the Medical Dictionary for Regulatory Activities. Effectiveness was assessed every 4 weeks using the 28-joint Disease Activity Score and the European League Against Rheumatism response criteria.Results.Of 13,861 patients (81% women) in the analysis, 3616, 2506, and 7739, respectively, were classified into etanercept monotherapy (ETN-mono), etanercept plus DMARD other than MTX (ETN + DMARD), and etanercept plus MTX (ETN + MTX) groups. Rates of AE and serious AE (SAE) in the ETN + MTX group were lower than in other groups. Risk of SAE or serious infections was not significantly increased with higher versus lower MTX doses at baseline or with concomitant use of salazosulfapyridine or bucillamine in ETN + DMARD versus ETN-mono groups. A greater likelihood of achieving clinical remission was seen with ETN + MTX versus ETN-mono (OR 1.36; 95% CI, 1.16–1.60; p < 0.001). Higher MTX dose at baseline was associated with a higher remission rate (> 8 mg vs 0 to ≤ 4 mg, OR 1.47, 95% CI 1.07–2.00, p = 0.016; 6 to ≤ 8 mg vs 0 to ≤ 4 mg, OR 1.27, 95% CI 1.01–1.60, p = 0.038).Conclusion.Combination therapies with etanercept plus MTX or other DMARD were reasonably well tolerated, and ETN + MTX at higher doses was more effective than ETN-mono in Japanese patients with RA.

scholarly journals Safety of Rituximab in Combination with Other Biologic Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis: An Open-label Study

2013 ◽  
Vol 40 (5) ◽  
pp. 599-604 ◽  
Author(s):  
William F.C. Rigby ◽  
Philip J. Mease ◽  
Ewa Olech ◽  
Mark Ashby ◽  
Swati Tole
Keyword(s):  
Rheumatoid Arthritis ◽  
Joint Disease ◽  
Inadequate Response ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Link Type ◽  
Disease Modifying

Objective.To characterize the safety of rituximab (RTX) in combination with biologic disease-modifying antirheumatic drugs (DMARD) in patients with rheumatoid arthritis (RA).Methods.We did an open-label study of the safety and efficacy of RTX in adult patients with active RA and an inadequate response to ≥ 1 biologic for ≥ 12 weeks (stable dose ≥ 4 weeks). RTX (2 × 500 mg) was added to patients’ current biologic and nonbiologic DMARD treatment. After 24 weeks, patients with 28-joint Disease Activity Score ≥ 2.6 were eligible for RTX retreatment. The primary endpoint was the proportion of patients developing a serious adverse event (SAE) within 24 weeks of initiating RTX.Results.Patients (n = 176) received RTX with 18 different biologic/DMARD combinations. Adalimumab alone (n = 46; 26.1%) or etanercept alone (n = 37; 21.0%) plus RTX were the most common combinations. Overall, 90.9% and 76.1% of patients completed 24 and 48 weeks, respectively; 147 patients (83.5%) received a second course of RTX. Over 24 weeks, 9.1% of patients reported SAE (24.3 events/100 patient-yrs, 95% CI 15.5–38.1). The SAE rate was similar over 48 weeks (22.4 events/100 patient-yrs, 95% CI 15.9–31.5). Four serious infections were reported over 48 weeks (2.7 events/100 patient-yrs, 95% CI 1.0–7.2). No SAE occurred within 24 h of any RTX infusion. Efficacy responses improved numerically at Week 48 compared with Week 24.Conclusion.The overall safety profile of RTX in combination with 1 other biologic was consistent with that previously reported for RTX plus methotrexate or other nonbiologic DMARD. (Clinicaltrials.govNCT00443651)

scholarly journals Anti-rheumatic treatment and prosthetic joint infection: An observational study in 494 elective hip and knee arthroplasties.

2019 ◽  
Author(s):  
Ylva Borgas ◽  
Anders Gülfe ◽  
Mikael Kindt ◽  
Anna Stefánsdóttir
Keyword(s):  
Periprosthetic Joint Infection ◽  
Joint Infection ◽  
Surgical Site Infections ◽  
Joint Disease ◽  
Tnf Alpha ◽  
First Year ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Prosthetic Joint ◽  
Disease Modifying

Abstract Background Surgical site infections are more frequent among patients with rheumatic disease. To which extent this is related to immunosuppressive antirheumatic drugs is unclear, as is the value of discontinuing medication perioperatively.Objectives To assess the rate of surgical site infections after knee and hip-replacement in patients with inflammatory joint disease, with emphasis on periprosthetic joint infection, and to investigate the importance of medical treatment in this regard.Methods Data was collected from 494 primary elective hip- (51.4%) and knee arthroplasties along with demographic and medication data and primary outcome was surgical site infections during the first year after surgery.Results In 78% (n=385) of the cases the patient medicated with 1 to 3 disease-modifying antirheumatic drugs perioperatively. Thirty two per cent (n=157) of patients were on a TNF-alpha inhibitor perioperatively. The rate of surgical site infections was 3.8% (n=19) The rate of periprosthetic joint infection was 1.4% (n=7), all of which were knee arthroplasties. Only in 1 case of periprosthetic joint infection the patient medicated perioperatively with a TNF-alpha inhibitor.Conclusion Surgical site infections was not associated with ongoing medication with disease-modifying antirheumatic drugs. Due to low event rate this should be interpreted with caution. Routines at our centre, not stopping biologic disease-modifying antirheumatic drugs perioperatively, will be unchanged.

scholarly journals Promising Therapeutic Targets for Treatment of Rheumatoid Arthritis

2021 ◽  
Vol 12 ◽  
Author(s):  
Jie Huang ◽  
Xuekun Fu ◽  
Xinxin Chen ◽  
Zheng Li ◽  
Yuhong Huang ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Therapeutic Targets ◽  
New Drugs ◽  
Joint Disease ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Sustained Development ◽  
Epigenetic Regulators ◽  
Disease Modifying ◽  
Hands And Feet

Rheumatoid arthritis (RA) is a systemic poly-articular chronic autoimmune joint disease that mainly damages the hands and feet, which affects 0.5% to 1.0% of the population worldwide. With the sustained development of disease-modifying antirheumatic drugs (DMARDs), significant success has been achieved for preventing and relieving disease activity in RA patients. Unfortunately, some patients still show limited response to DMARDs, which puts forward new requirements for special targets and novel therapies. Understanding the pathogenetic roles of the various molecules in RA could facilitate discovery of potential therapeutic targets and approaches. In this review, both existing and emerging targets, including the proteins, small molecular metabolites, and epigenetic regulators related to RA, are discussed, with a focus on the mechanisms that result in inflammation and the development of new drugs for blocking the various modulators in RA.

scholarly journals Two-year Efficacy and Safety of Subcutaneous Tocilizumab in Combination with Disease-modifying Antirheumatic Drugs Including Escalation to Weekly Dosing in Rheumatoid Arthritis

2017 ◽  
Vol 45 (4) ◽  
pp. 456-464 ◽  
Author(s):  
Alan Kivitz ◽  
Ewa Olech ◽  
Michael A. Borofsky ◽  
Beatriz Zazueta ◽  
Federico Navarro-Sarabia ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Joint Disease ◽  
Published Data ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Serious Adverse Events ◽  
Disease Modifying

Objective.To evaluate the longterm efficacy and safety of subcutaneous tocilizumab (TCZ-SC) every 2 weeks (q2w) over 2 years in patients with rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARD).Methods.Patients (n = 656) were randomized 2:1 to TCZ-SC 162 mg q2w or placebo-SC q2w plus DMARD. After a 24-week double-blind period, patients (n = 457) were rerandomized to open-label TCZ-SC q2w by means of prefilled syringe or autoinjector. Escape therapy with weekly TCZ-SC was available for patients with inadequate efficacy from Week 12. Maintenance of response and safety to 2 years was assessed. Analyses used nonresponder imputation.Results.The American College of Rheumatology (ACR) 20 response after TCZ-SC was maintained beyond Week 24 and was > 70% at each timepoint. ACR50/70, 28-joint Disease Activity Score remission, and ≥ 0.30 decrease from baseline in the Health Assessment Questionnaire–Disability Index response rates were also maintained after Week 24 in the TCZ-SC arm (≥ 50%, > 25%,> 32% and > 56%, respectively). Following escape for inadequate efficacy, many patients achieved ACR20 at the end of the study, 35% after escape from TCZ-SC, and 63% from placebo. The rates of serious adverse events [(11.20/100 patient-years (PY)] including serious infections (3.25/100 PY) were stable through Week 96. No association between anti-TCZ antibody development and loss of efficacy or adverse events was observed.Conclusion.Efficacy and safety of TCZ-SC q2w was maintained up to 2 years and remained comparable with previously published data for intravenous TCZ. Dose escalation to weekly TCZ-SC was associated with ACR responses in prior nonresponders and was well tolerated.

Indikationen und Wirksamkeit der Anti-TNF-Therapie

2009 ◽  
Vol 29 (04) ◽  
pp. 205-213
Author(s):  
M. Pierer ◽  
U. Wagner ◽  
C. Baerwald ◽  
O. Malysheva
Keyword(s):  
Rheumatische Erkrankungen ◽  
Sich Eine ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Fand Sich ◽  
Psoriasis Arthritis ◽  
Disease Modifying

ZusammenfassungRheumatische Erkrankungen sind schwere Erkrankungen, die mit anhaltenden Schmerzen einhergehen, zum Verlust an Lebensqualität, Funktion, Arbeitsfähigkeit und auch zur Verkürzung des Lebens führen können. Sie verursachen erhebliche Kosten für das Gesundheitssystem. Mehrere Biologika als neue „disease modifying antirheumatic drugs“ sind in die Therapie von rheumatoider Arthritis, Spondyloarthropathien, Psoriasis-Arthritis und idiopathischer juveniler Arthritis eingeführt worden. Es fand sich eine zum Teil große Effektivität der Biologika, wobei dieser Artikel sich auf die Anti-TNF-Therapien, nämlich Adalimumab, Etanercept und Infliximab, konzentriert. Weitere Anti-TNF Therapien sind in Entwicklung. Mit deren Zulassung ist in den nächsten Monaten zu rechnen.

Quality of life of patients with Sjogren’s disease with ongoing therapy with diseasemodifying antirheumatic drugs

2020 ◽  
pp. 33-38
Author(s):  
E. Yu. Gan ◽  
L. P. Evstigneeva
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Life Quality ◽  
Well Being ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Sf 36 ◽  
Disease Modifying ◽  
Sjögren’S Disease

Purpose of the study. Assessing the association between the life quality of patients with Sjogren’s Disease and ongoing therapy with various disease-modifying antirheumatic drugs.Material and methods. The study was conducted on the basis of the regional rheumatology center of the consultative diagnostic clinic of the Sverdlovsk Regional Clinical Hospital No. 1. This work is based on the results of a simultaneous study of 74 patients with primary Sjogren’s Disease (SD), distributed in three comparison groups receiving various disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine. The diagnosis of SD was carried out according to European-American criteria AECGC (2002) [18]. In order to analyze the quality of life of patients with SD, the 36-Item Short Form Health Survey (SF‑36) was used. Statistical data processing was carried out using Statistica 7.0 program.Results. Assessment of the quality of life of patients with SD, which is an integrative criterion of human health and well-being, revealed the absence of statistically significant differences (p > 0.05) on eight scales and two health components of the SF‑36 questionnaire in the analyzed groups that differ in the treatment of disease-modifying antirheumatic drugs chlorambucil, methotrexate and hydroxychloroquine.Conclusions. The obtained data indicate an equivalent quality of life in SD patients treated with different disease-modifying antirheumatic drugs methotrexate, chlorambucil and hydroxychloroquine, and therefore hydroxychloroquine can be considered as an alternative basic therapy in patients with SD with certain limitations and contraindications methotrexate and chlorambucil.

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