PMS27 Access Limitation of IMPACT on PCOS in Rheumatoid Arthritis Patients Treated with Tofacitinib or Biological Dmards in Real Life Conditions in Two LATIN-American Countries

2021 ◽  
Vol 24 ◽  
pp. S143
Author(s):  
Sanchez JM Reyes ◽  
Ardila M Gutierrez ◽  
H. Madariaga ◽  
de Leon D Ponce ◽  
T. Lukic
2021 ◽  
Vol 24 ◽  
pp. S142
Author(s):  
Ardila M Gutierrez ◽  
Sanchez JM Reyes ◽  
H. Madariaga ◽  
T. Lukic ◽  
de Leon D Ponce

2021 ◽  
Vol 61 (1) ◽  
Author(s):  
Gabriela Bittencourt Gonzalez Mosegui ◽  
Fernando Antõnanzas ◽  
Cid Manso de Mello Vianna ◽  
Paula Rojas

Abstract Background The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies’ databases. The pricing between countries was based on purchasing power parity (PPP). Results The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain’s price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusion The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.


2015 ◽  
Vol 74 (Suppl 2) ◽  
pp. 996.1-996
Author(s):  
R.M. Xavier ◽  
J. Morales-Torres ◽  
D.C.R. Ramos-Remus ◽  
P. Chalem ◽  
J.F. Molina ◽  
...  

2015 ◽  
Vol 44 (5) ◽  
pp. 506-513 ◽  
Author(s):  
Lydia Abasolo ◽  
Leticia Leon ◽  
Luis Rodriguez-Rodriguez ◽  
Aurelio Tobias ◽  
Zulema Rosales ◽  
...  

2019 ◽  
Vol 11 (1) ◽  
pp. 1-9
Author(s):  
Umut Kalyoncu ◽  
Ali İhsan Ertenli ◽  
Orhan Küçükşahin ◽  
Hüseyin Ediz Dalkılıç ◽  
Abdulsamet Erden ◽  
...  

Author(s):  
Umut Kalyoncu ◽  
Ali İhsan Ertenli ◽  
Abdulsamet Erden ◽  
Orhan Küçükşahin ◽  
Timuçin Kaşifoğlu ◽  
...  

2021 ◽  
Author(s):  
JM Reyes ◽  
MV Gutierrez ◽  
H Madariaga ◽  
W Otero ◽  
R Guzman ◽  
...  

Abstract Objective: To describe the efficacy, safety and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) treated with tofacitinib or biological DMARDs (bDMARDs) in real-life conditions.Methods: A noninterventional study was performed between March 2017 and September 2019 at 13 sites in Colombia and Peru. Demographic and clinical information was collected. Outcomes measured at baseline and at the 6-month follow-up were disease activity (RAPID3 [Routine Assessment of Patients Index Data] score), functional status (HAQ-DI [Health Assessment Questionnaire] score), and quality of life (EQ-5D-3L [EuroQol Questionnaire]). The Disease Activity Score-28 (DAS28-ESR) and frequency of adverse events (AEs) were also reported. Unadjusted and adjusted differences from baseline were estimated and expressed as the least squares mean difference (LMDs).Results: Data from 100 patients treated with tofacitinib and 70 patients with bDMARDs were collected. At baseline, the patients’ mean age was 53.53 years (SD 13.77), the mean disease duration was 6.31 years (SD 7.01) and the mean DAS28-ESR was 5.48 (SD 2.97). The change from baseline at month 6 was not statistically significant different in the adjusted LMD [SE] for tofacitinib vs. bDMARDs for RAPID3 score (-0.20 [0.69] vs. -0.32 [0.71]), HAQ-DI score (-0.56 [0.07] vs. -0.50 [0.08]), EQ-5D-3L score (0.23 [0.06] vs. 0.29 [0.06]) and DAS28-ESR (-3.86 [0.59] vs. -4.23 [0.61]). Patients from both groups presented similar proportions of nonserious and serious AEs. No deaths were reported. These results have noninterventional-study-specific limitations.Conclusion: Changes from baseline were not statistically significant different between tofacitinib and bDMARDs in terms of RAPID3 scores and the secondary outcomes (HAQ-DI score, EQ-5D-3L score and DAS28-ESR). Patients from both groups presented similar proportions of nonserious and serious AEs.Clinical trial number: NCT03073109


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