scholarly journals FRI0116 COMPARABLE EFFICACY AND SAFETY OF TWO REGIMENS OF RHEUMATOID ARTHRITIS TREATMENT WITH TOFACITINIB: DATA FROM RUSSIAN NATIONAL REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 639-639
Author(s):  
A. Babaeva ◽  
E. Kalinina ◽  
E. Nasonov ◽  
V. Mazurov ◽  
G. Lukina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Therapy Group ◽  
Target Therapy ◽  
Combined Therapy ◽  
National Registry ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
National Guidelines ◽  
Therapy Regimen ◽  
Conventional Dmards

Background:Current EULAR and national guidelines recommend use of synthetic target drug Tofacitinib (TOFA) for active rheumatoid arthritis (RA) treatment in case of resistance or intolerance to metotrexate (MTX) or other conventional DMARDs. Two treatment regimens are approved: TOFA mono-therapy and combination with conventional DMARD, preferably with MTX.Objectives:Aim of presented study was to compare efficacy and safety of TOFA given in two regimens: as mono-therapy and in combination with MTX.Methods:We analyzed data from Russian national registry of RA. 450 patients (pts) treated with TOFA in dose 10 mg daily have been enrolled in this investigation. Among them 169 pts have composed TOFA mono-therapy group (mono) and 281 pts treated with TOFA plus MTX have been included in combo-therapy group (combo). Period of treatment varied from 6 months to 3 years and even more. Treatment efficacy was evaluated on the basis of clinical and laboratory indices of RA activity: CDAI, SDAI, DAS28, HAQ, GPA (general pain assessment), TJC, SJC, CRP, ESR monthly during first 6 months, than in 1,2,3 years and after 3 year period of treatment.Results:There were no significant differences in pts demographic characteristic and disease longevity and/or severity in two separated groups. Majority of baseline indices were identical in these groups aside from SDAI, CRP (were higher in combo-group) and HAQ (was higher in mono-group). Pts monitoring have shown dramatically decrease of all used indices during the first several months of therapy in both groups. Moreover all clinical and laboratory parameters after 6-months treatment were comparable in mono- and combo- groups. Positive dynamics remained during further 3-year period in both groups. Significant differences between baseline and ultimate data after 3 year course therapy were revealed in CDAI, SDAI, DAS28, HAQ, GPA, TJC, SJC, CRP, ESR in both groups. In particular DAS28 index decreased from 5.38±0.08 to 2.88±0.07 (p<0.05) in mono-group and from 5.54±0.09 to 3.40±0.21 (p<0.05) in combo-group. Along with this comparing of endpoints in two analyzed groups have shown that levels of CDAI, SDAI, GPA were significant higher in combo-group than in mono-group (p<0.05). Adverse effects were registered in 4.73% pts from mono-group and in 4.98% pts from combo-group (p>0.05). Spectrum of adverse reactions was similar in compared groups: respiratory infection (in 2.96% and 3.36% cases respectively) and herpes infection (in 0.59% and 0.71% cases, respectively) were registered predominantly.Conclusion:Data gained from National RA registry have demonstrated that treatment with TOFA in mono-therapy regimen has the comparable efficacy with regimen of combined therapy, included MTX and TOFA. Safety of both regimens can be qualified as good. Obtained results confirm high efficacy and safety of target therapy with TOFA and prove the recommendation for use it in different regimens – mono-therapy or combination with MTX.References:[1]Smolen JS, et al. Ann Rheum Dis. 2017;0:1–18. doi:10.1136/annrheumdis-2016-210715[2]Boyle DL, et al. Ann Rheum Dis. 2015;74:1311-1316. doi:10.1136/annrheumdis-2014-206028Disclosure of Interests:Aida Babaeva: None declared, Elena Kalinina: None declared, Evgeny Nasonov Speakers bureau: Lilly, AbbVie, Pfizer, Biocad, R-Pharm, V Mazurov: None declared, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Antonina Davydova: None declared, Irina Semizarova: None declared, Olga Slyusar: None declared, Tatyana Rasevich: None declared, Ruzana Samigullina: None declared, Diana Abdulganieva: None declared

scholarly journals Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3)

2019 ◽  
Vol 78 (10) ◽  
pp. 1320-1332 ◽  
Author(s):  
Yoshiya Tanaka ◽  
Tsutomu Takeuchi ◽  
Sakae Tanaka ◽  
Atsushi Kawakami ◽  
Manabu Iwasaki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Response Rates ◽  
Janus Kinase ◽  
Phase Iii ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
Once Daily ◽  
Conventional Dmards

ObjectivesTo investigate the efficacy and safety of peficitinib, an oral Janus kinase inhibitor, in patients with rheumatoid arthritis (RA).MethodsIn this double-blind phase III study, patients with RA and an inadequate response to prior disease-modifying anti-rheumatic drugs (DMARDs) were randomised to peficitinib 100 mg once daily, peficitinib 150 mg once daily, placebo or open-label etanercept for 52 weeks’ treatment; placebo-treated patients were switched at week 12 to peficitinib 100 or 150 mg once daily. The primary endpoint was American College of Rheumatology (ACR)20 response at week 12/early termination (ET). Secondary endpoints (assessed throughout) included ACR20, ACR50 and ACR70 response, changes from baseline in disease activity scores (DAS)28 and ACR core parameters, adverse events (AEs) and changes in clinical or laboratory measurements.ResultsIn total, 507 patients received treatment. ACR20 response rates at week 12/ET were significantly higher in the peficitinib 100 mg (57.7%) and 150 mg (74.5%) groups versus placebo (30.7%) (p<0.001). ACR50/70 response rates were also higher for both peficitinib doses versus placebo. Improvements in ACR response were maintained until week 52. Changes from baseline in DAS28-C-reactive protein/erythrocyte sedimentation rate and the ACR core set were significantly greater for both peficitinib doses versus placebo at week 12/ET (p<0.001). AE incidence was similar across treatment arms. Incidence of serious infection and herpes zoster-related disease was higher with peficitinib versus placebo, but with no clear dose-dependent increase.ConclusionsIn patients with RA and inadequate response to DMARDs, peficitinib 100 mg once daily or 150 mg once daily was efficacious in reducing RA symptoms and was well tolerated compared with placebo.Trial registration numberNCT02308163.

scholarly journals Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4

2017 ◽  
Vol 76 (12) ◽  
pp. 1986-1991 ◽  
Author(s):  
Paul Emery ◽  
Jiří Vencovský ◽  
Anna Sylwestrzak ◽  
Piotr Leszczyński ◽  
Wieslawa Porawska ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Response Rates ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Term Efficacy ◽  
Open Label Extension ◽  
Extension Period

ObjectivesSB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In a randomised, double-blind, 52-week study, SB4 demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA). The open-label extension period evaluated long-term efficacy, safety and immunogenicity when continuing SB4 versus switching from ETN to SB4.MethodsIn the randomised, double-blind phase, patients received weekly subcutaneous administration of 50 mg SB4 or ETN with background methotrexate for up to 52 weeks. Patients in the Czech Republic and Poland who completed the 52-week visit were enrolled in the open-label extension period and received SB4 for 48 additional weeks. Efficacy, safety and immunogenicity were assessed up to week 100.ResultsOf 245 patients entering the extension period, 126 continued to receive SB4 (SB4/SB4) and 119 switched to SB4 (ETN/SB4). American College of Rheumatology (ACR) response rates were sustained and comparable between SB4/SB4 and ETN/SB4 with ACR20 response rates at week 100 of 77.9% and 79.1%, respectively. Other efficacy results, including radiographic progression, were also comparable between the groups. After week 52, rates of treatment-emergent adverse events were 47.6% (SB4/SB4) and 48.7% (ETN/SB4); one patient/group developed non-neutralising antidrug antibodies. No cases of active tuberculosis or injection-site reactions were reported during the extension period. One patient (SB4/SB4) died of hepatic cancer.ConclusionsSB4 was effective and well tolerated over 2 years in patients with RA. Efficacy, safety and immunogenicity were comparable between the SB4/SB4 and ETN/SB4 groups, showing no risk associated with switching patients from ETN to SB4.Trial registration numberNCT01895309; 2012-005026-30

Efficacy and Safety of CH-1504, a Metabolically Stable Antifolate, in Patients with Active Rheumatoid Arthritis: Results of a Phase II Multicenter Randomized Study

2011 ◽  
Vol 38 (9) ◽  
pp. 1875-1883 ◽  
Author(s):  
EDWARD C. KEYSTONE ◽  
VALERY S. SHIRINSKY ◽  
LEE S. SIMON ◽  
SIMON PEDDER ◽  
L. ARTHUR HEWITT ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Phase Ii ◽  
Active Rheumatoid Arthritis ◽  
Joint Disease ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Acr20 Response ◽  
Treatment Groups ◽  
Oral Doses

Objective.To investigate the potential efficacy, safety, and tolerability of daily use of CH-1504 in patients with active rheumatoid arthritis (RA). US National Institutes of Health database no. NCT00658047.Methods.In our phase II randomized double-blind double-dummy study, patients naive to methotrexate (MTX; n = 201) and having moderate to severe RA received either CH-1504 (0.25 mg, 0.5 mg, or 1.0 mg once-daily oral doses) or MTX (titrated to 20.0 mg once-weekly oral doses). All received weekly 10-mg folate supplementation. Efficacy and safety were assessed at 2, 4, 8, and 12 weeks, with a treatment-free followup at 16 weeks. Safety and tolerability were assessed. Primary efficacy endpoint was proportion of patients achieving ACR20 response at Week 12. Secondary endpoints included difference from baseline in the 28-joint Disease Activity Score (DAS28) and individual components of the American College of Rheumatology (ACR) composite index.Results.Demographic characteristics were similar in all treatment groups: mean age 54.3 ± 11.4 years, female sex 87%, mean baseline DAS28 6.6 ± 0.9. At Week 12, CH-1504 demonstrated comparable efficacy compared to MTX as measured by ACR20, DAS28, and ACR composite core-set measures, including tender and swollen joints. No dose-response relationship was observed. Adverse events across treatment groups were mild. Liver enzyme levels increased from baseline to Week 16 in the MTX group, with qualitatively lesser increases in the CH-1504 groups. Two patients in the MTX group withdrew because of gastrointestinal-related adverse events. CH-1504 appeared safe and well tolerated at all dose levels.Conclusion.CH-1504 has comparable efficacy to MTX and is safe and well tolerated. Metabolically stable antifolates are a promising therapeutic option that warrants further study.

scholarly journals Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study

2016 ◽  
Vol 76 (2) ◽  
pp. 355-363 ◽  
Author(s):  
Dae Hyun Yoo ◽  
Nenad Prodanovic ◽  
Janusz Jaworski ◽  
Pedro Miranda ◽  
Edgar Ramiterre ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Safety Data ◽  
Extension Study ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Open Label ◽  
Acr20 Response ◽  
American College Of Rheumatology ◽  
Switch Group ◽  
Maintenance Group

ObjectivesTo assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions.MethodsThis open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group).ResultsOverall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively).ConclusionsComparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years.Trial registration numberNCT01571219; Results.

scholarly journals Experience of using a genetically engineered biological drug biosimilar in patients with rheumatoid arthritis in real clinical practice

2020 ◽  
Vol 4 (8) ◽  
pp. 492-497
Author(s):  
E.V. Zhilyaev ◽  
◽  
E.N. Koltsova ◽  
E.I. Shmidt ◽  
K.A. Lytkina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Adverse Events ◽  
Treatment Efficacy ◽  
Genetically Engineered ◽  
Efficacy And Safety ◽  
Biological Drug ◽  
Therapy Regimen ◽  
Switching Therapy ◽  
Real Clinical Practice

The article presents the data of the Moscow Unified Arthritis Register (MUAR) and the results of rituximab therapy in patients with rheumatoid arthritis (RA).Aim: to evaluate the efficacy and safety of switching from the original rituximab (MabThera®) to its biosimilar (Acellbia®) in patients with RA in real clinical practice.Patients and Methods: patients with RA, included in MUAR register, were evaluated with an assessment of therapy efficacy and safety with the original rituximab (MabThera®), as well as after switching to the rituximab biosimilar (Acellbia®). A standard examination was performed to determine the number of swollen and tender joints, erythrocyte sedimentation rate, and C-reactive protein. Treatment efficacy was assessed using the DAS28 composite index, HAQ-DI (Health Assessment Questionnaire Disability Index) and RAPID-3 (Routine Assessment of Patient Index Data 3). In terms of safety, adverse events were recorded based on patient reports.Results: switching therapy regimen of 46 patients with RA from the original rituximab to the biosimilar was not accompanied by a decrease in the treatment efficacy. There was statistically significant increase in the proportion of the patients with low disease activity (DAS28<3.2) from 39.1% to 52.2% and remission (DAS28<2.6) from 17.4% to 23.9%, respectively. Further positive dynamics of HAQ-DI and RAPID-3 indices were noted. According to the authors, the increase in the frequency of a positive response to the treatment was associated with the duration of rituximab use in general. The frequency of adverse events during therapy with the original rituximab and its biosimilar was comparable: 9.22 and 10.9 per 100 patient years respectively.Conclusion: there were no significant differences between the original rituximab and its biosimilar. The results of switching therapy regimen of patients with RA from the original rituximab (MabThera®) to its biosimilar (Acellbia®), observed in real clinical practice, confirm their therapeutic equivalence.KEYWORDS: rheumatoid arthritis, rituximab, biosimilar, real clinical practice.FOR CITATION: Zhilyaev E.V., Koltsova E.N., Shmidt E.I. et al. Experience of using a genetically engineered biological drug biosimilar in patients with rheumatoid arthritis in real clinical practice. Russian Medical Inquiry. 2020;4(8):492–497. DOI: 10.32364/2587-6821-2020-4-8-492-497.

scholarly journals Effectiveness of iguratimod as monotherapy or combined therapy in patients with rheumatoid arthritis: a systematic review and meta-analysis of RCTs

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Chao-Jun Hu ◽  
Li Zhang ◽  
Shuang Zhou ◽  
Nan Jiang ◽  
Jiu-Liang Zhao ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomized Clinical Trials ◽  
Therapy Group ◽  
Combined Therapy ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Medical Network ◽  
Potential Alternative

Abstract Background This study aims to evaluate the efficacy and safety of the iguratimod (IGU) as monotherapy or combined therapy in patients with rheumatoid arthritis (RA) by using meta-analysis. Methods We searched Medline, EMBASE, Cochrane library, CNKI, Wanfang medical network from initial to 30 June, 2020, for randomized clinical trials (RCTs). Two authors independently screened the studies via reading the title, abstract, and full text. The risk of bias in individual studies was assessed using the Cochrane Risk of Bias tool. STATA 12.0 was used for pooled analysis of all included studies. Results A total of 23 RCTs were included in this analysis. Meta-analysis showed that patients in the IGU monotherapy or combined therapy group had significantly higher ACR20 (OR = 1.97, 95% CI 1.29 to 3.00, P = 0.002), lower DAS28-CRP (SMD = −3.49, 95% CI −5.40 to −1.58, P < 0.001) and DAS28-ESR (SMD = −2.61, 95% CI −3.64 to −1.57, P < 0.001), as well as shorter duration of morning stiffness (SMD = −2.06, 95% CI −2.86 to −1.25, P < 0.001) and lower HAQ score (SMD = −0.91, 95% CI −1.61 to −0.21, P = 0.011), than those received other disease-modifying antirheumatic drugs (DMARDs) monotherapy (primarily comprising methotrexate). For the safety profile, IGU monotherapy had similar risks for gastrointestinal reactions (P = 0.070), leucopenia (P = 0.309), increment in transaminase (P = 0.321), increase of ALT (P = 0.051), and liver damage (P = 0.182) to methotrexate monotherapy, and IGU combined with other DMARDs therapy did not increase the risks of these AEs (P > 0.05). Conclusions Our evidence suggests that IGU is effective and tolerant as monotherapy or combined therapy especially with methotrexate in patients with active RA. IGU may be regarded as a potential alternative to methotrexate, and a preferable choice when combined with other DMARDs for the treatment of RA.

Endovenous procedures in varicose veins

Phlebologie ◽  
2008 ◽  
Vol 37 (05) ◽  
pp. 229-236
Author(s):  
N. Cayne ◽  
G. Jacobowitz ◽  
P. Lamparello ◽  
T. Maldonado ◽  
C. Rockman ◽  
...  
Keyword(s):  
Varicose Veins ◽  
Treatment Options ◽  
Postoperative Recovery ◽  
Comparable Efficacy ◽  
Intense Pulse Light ◽  
Efficacy And Safety ◽  
Endovenous Laser Ablation ◽  
The Past ◽  
Early Evidence ◽  
Endovenous Treatment

SummaryOver the past ten years endoveous treatment options for varicose veins have evovled considerably, offering clinicians a multitude of options to meet the needs of their patients. The endothermal ablation procedures have moved to the forefront as the choice modality for treating truncal reflux. Both radiofrequency ablation and endovenous laser ablation are widely accepted and interchangeable, showing comparable efficacy and safety. Although numerous endovenous laser wavelengths exist, the data indicates that the differences do not affect the efficacy or postoperative recovery of the procedure. The endovenous laser innovation that has shown early evidence of improved patient outcome is the jacket-tip fiber. The versatility of sclerotherapy makes it a critical component in the endovenous treatment of varicosities. Although not approved by the Food and Drug Administration (USA), the use of a foamed sclerosing agent is the fastest growing segment of sclerotherapy and an important treatment modality in the future of varicose vein treatment. Cutaneous lasers and intense pulse light devices contribute a crucial element, enabling clinicians to treat minute veins that may be impossible to treat with other therapies.

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