Objective: To assess the efficacy and safety of tocilizumab (TCZ) in Caucasian patients with refractory Takayasu’s arteritis (TAK) in clinical practice. Methods: A multicenter study of Caucasian patients with refractory TAK who received TCZ. The outcome variables were remission, glucocorticoid-sparing effect, improvement in imaging techniques, and adverse events. A comparative study between patients who received TCZ as monotherapy (TCZMONO) and combined with conventional disease modifying anti-rheumatic drugs (cDMARDs) (TCZCOMBO) was performed. Results: The study comprised 54 patients (46 women/8 men) with a median [interquartile range (IQR)] age of 42.0 (32.5–50.5) years. TCZ was started after a median (IQR) of 12.0 (3.0–31.5) months since TAK diagnosis. Remission was achieved in 12/54 (22.2%), 19/49 (38.8%), 23/44 (52.3%), and 27/36 (75%) patients at 1, 3, 6, and 12 months, respectively. The prednisone dose was reduced from 30.0 mg/day (12.5–50.0) to 5.0 (0.0–5.6) mg/day at 12 months. An improvement in imaging findings was reported in 28 (73.7%) patients after a median (IQR) of 9.0 (6.0–14.0) months. Twenty-three (42.6%) patients were on TCZMONO and 31 (57.4%) on TCZCOMBO: MTX ( n = 28), cyclosporine A ( n = 2), azathioprine ( n = 1). Patients on TCZCOMBO were younger [38.0 (27.0–46.0) versus 45.0 (38.0–57.0)] years; difference (diff) [95% confidence interval (CI) = -7.0 (-17.9, -0.56] with a trend to longer TAK duration [21.0 (6.0–38.0) versus 6.0 (1.0–23.0)] months; diff 95% CI = 15 (-8.9, 35.5), and higher c-reactive protein [2.4 (0.7–5.6) versus 1.3 (0.3–3.3)] mg/dl; diff 95% CI = 1.1 (-0.26, 2.99). Despite these differences, similar outcomes were observed in both groups (log rank p = 0.862). Relevant adverse events were reported in six (11.1%) patients, but only three developed severe events that required TCZ withdrawal. Conclusion: TCZ in monotherapy, or combined with cDMARDs, is effective and safe in patients with refractory TAK of Caucasian origin.
Background:Tocilizumab (TCZ) was recently approved for Takayasu Arteritis (TAK) in Japan based on the results of the TAKT trial(1).However, data in clinical practice in Europe and America are scarce(2).Objectives:To assess efficacy and safety of TCZ in TAK of clinical practice in Spain.Methods:Observational, open-label multicentre study of 53 TAK patients treated with TCZ due to refractoriness or adverse events of previous therapy. Outcomes variables were improvement of clinical features, acute phase reactants and glucocorticoid-sparing effect.Results:53 patients (46w/7m); mean age, 40.6±14.6 years at TCZ onset. TCZ was started after a median of 12 [3.0-48.0] months from TAK diagnosis. In addition to systemic corticosteroids and before TCZ they received conventional immunosuppressant drugs (n=42) and biologic therapy (n=14). TCZ was prescribed as standard I.V. (n=42; 79.2%) or subcutaneous (n=11; 20.8%). The initial dose was 8 mg/kg/IV/4 weeks or 162 mg/SC/week, respectively. TCZ was used in monotherapy or combined with immunosuppressants (n=32; 60.4%): methotrexate (n=27), azathioprine (n=2), cyclosporine (n=3). Main clinical features at TCZ onset were: malaise (n=30),limb claudication (n=22), headache (n=18), fever (n=14), abdominal pain (n=10), and chest pain (n=9). Most of the patients experienced a rapid and maintained clinical, analytical improvement(TABLE).After a median follow-up of 18.0 [7.0-45.0] months, TCZ was discontinued in 20 patients due to: sustained remission (n=6), relapse (n=6), adverse event (n=5), gestation (n=3). Most relevant adverse side effects were serious infections: pneumonia (n=2), herpes zoster (n=1), abdominal sepsis (n=1).Table.Basal(N=53)Month 1(N=53)Month 3(N=46)Month 6(N=44)Month 12(N=34)Clinical improvement, n/N(%)Complete17/53 (32.1)19/46 (41.3)23/44 (52.3)26/34 (76.5)Partial30/53 (54.6)26/46 (56.5)18/44 (40.9)8/34 (23.5)No improvement6/53 (11.3)1/46 (2.2)3/44 (6.8)0/34 (0.0)Analytical markers,ESR (mm/1sth),median [IQR]35.0 [16.0-52.0]7.5 [3.0-14.0] *3.5 [2.0-8.0]*5.0[2.0-6.0]*5.0 [2.0-8.5]*CRP (mg/dL),median [IQR]1.7 [0.6 -3.5]0.21 [0.05-0.6]*0.14 [0.05-0.5]*0.14 [0.04-0.4]*0.10 [0.03-0.30]*Hb (g/dL),mean±SD12.3±1.512.8±1.2*12.9±1.3*12.9±1.4*12.9±1.4*Prednisone dose (mg/day),median [IQR]30.0 [15.0-50.0]20.0 [10.0-37.5]*10.0 [5.0-20.0]*5.0 [5.0-12.5]*5.0 [0.0-7.5]**Wilcoxon test p < 0.001.Conclusion:TCZ appears to be effective and safe in patients with refractory TAK in clinical practice.References:[1]Nakaoka Y et al. Ann Rheum Dis. 2018;77:348-354[2]Loricera J et al. Clin Exp Rheumatol. 2016; 34: S44-53.Disclosure of Interests:D. Prieto-Peña: None declared, Monica Calderón-Goercke: None declared, Pilar Bernabéu: None declared, Paloma Vela-Casasempere: None declared, J. Narváez: None declared, Carlos Fernández-López: None declared, Mercedes Freire González: None declared, Beatriz González-Alvarez: None declared, Roser Solans-Laqué: None declared, Jose Luis Callejas-Rubio: None declared, Norberto Ortego: None declared, Carlos Fernández-Díaz Speakers bureau: Brystol Meyers Squibb, Esteban Rubio Romero: None declared, SALVADOR GARCÍA MORILLO: None declared, Mauricio Minguez: None declared, Cristina Fernández-Carballido Consultant of: Yes, I have received fees for scientific advice (Abbvie, Celgene, Janssen, Lilly and Novartis), Speakers bureau: Yes, I have received fees as a speaker (Abbvie, Celgene, Janssen, Lilly, MSD, Novartis), Eugenio de Miguel Grant/research support from: Yes (Abbvie, Novartis, Pfizer), Consultant of: Yes (Abbvie, Novartis, Pfizer), Paid instructor for: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Speakers bureau: yes (AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi), Sheila Melchor: None declared, Eva Salgado-Pérez: None declared, Beatriz Bravo: None declared, Susana Romero-Yuste: None declared, J Salvatierra: None declared, Cristina Hidalgo: None declared, Sara Manrique Arija: None declared, C. Romero-Gómez: None declared, Patricia Moya: None declared, Noelia Alvarez-Rivas: None declared, Javier Mendizabal: None declared, Francisco Miguel Ortiz Sanjuan: None declared, I. Pérez de Pedro: None declared, Javier Loricera: None declared, Santos Castañeda: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, Ricardo Blanco Grant/research support from: AbbVie, MSD, Roche, Consultant of: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Speakers bureau: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma. MSD
Background:With the arrival of biosimilar drugs and savings policies to make the health system sustainable, hospital managers have chosen to make changes from original molecules to biosimilar drugs.Objectives:This work aims to reflect what happens when making these switchings.Methods:We reviewed 235 patients who started Etanercept original in Rheumatology at Navarra Hospital Complex and Henares University Hospital and their switch to Etanercept biosimilar with a follow-up of 6 months.Results:The switch was performed in 174 patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), juvenile idiopathic arthritis, SAPHO and spondyloarthritis.9.8% discontinued treatment: 6 RA (8.1%), 5 PsA (9.8 %) and 6 AS (20.7%); all of them in the injection presentation. 12 patient stopped treatment due to ineffecacy, 2 due to reaction at the injection site, 2 due to diarrhea and 1 due to headache. Among 88.2% of patients who returned to Etanercept original, 28.6% did not achieve good response and had to change of treatment. The median time from Etanercept original beginning until the moment of switching was 54 (40-87) months.Conclusion:In our series, approximately 10% of switching patients failed after a 6-month of follow-up; when trying to return to Etanercept original 28.6% did not achieve response.The median persistence time in the original molecule and the percentage of failures observed in AS could be two conditions to consider before switching.A longer-term follow-up and a greater number of patients are necessary to ratify these data.Table 1DISEASESTOPPED CAUSEBACK TO Etanercept originalCONTINUE Etanercept originalTIME UNTIL SWITCH (meses)ASReaction at the injection siteYesYes28ASHeadacheYesYes54ASIneffecacyYesYes126RAIneffecacyYesNo25ASDiarrheaYesYes87RAIneffecacyYesYes37PsAIneffecacyNoNo43RAIneffecacyYesYes54PsAIneffecacyYesNo93PsAIneffecacyNoNo132PsAIneffecacyYesYes62RAIneffecacyYesYes142RAReaction at the injection siteYesYes51RAIneffecacyYesNo56PsAIneffecacyYesNo40ASIneffecacyYesYes26ASDiarrheaYesYes48Disclosure of Interests:Vicente Aldasoro Speakers bureau: Roche, Abbvie, MSD, UCB, Pfizer, Menarini, Grunenthal, Gebro, Novartis, Janssen, Javier Mendizabal: None declared, Sara Perez Garcia: None declared, Guillen Sada Urmeneta: None declared, Juliana Restrepo Vélez: None declared, Natividad del Val del Amo: None declared, Inmaculada Paniagua Zudaire: None declared, Ricardo Gutiérrez Polo: None declared, Loreto Horcada: None declared, Laura Garrido Courel: None declared, C. Fito-Manteca: None declared
Background:Biosimilar drugs has supposed a huge savings in our health systems and there are data that conclude that they work as original molecules when we making these switchings. There are limited studies that analize these patients across the time (1-3).Objectives:Long term follow up of patients after switching from original etanercept to biosimilar drug.Methods:We reviewed 187 patients who started Etanercept original in Rheumatology department at Navarra Hospital Complex and their switch to Etanercept biosimilar with a follow-up of 18 months.Results:The switch was performed in 176 patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) and psoriatic arthritis (PsA).At 18 months of follow-up 26,1% discontinued treatment; 13% at 6 months, 9,1% at 12 months and 4% patients at 18 months. The median time in etanercept original drug before switching was 52 months.There were 46 withdrawal patients with etanercept biosimilar: 34 inefficacy, 3 skin reaction, 2 malignancies (lymphoma and GIST), 1 injection site reaction, 1 headache, 1 diarrhea, 1 recurrent urinary infection, 1 heart failure and 2 deaths. 25 patients returned to Etanercept original but 3 did not achieve good response; all of them in RA group.Conclusion:In our series 50 % of withdrawal happened at 6 months of follow-up. 73,9% had a good response with etanercept biosimilar at 18 months. The main reason to stop biosimilar drug was inefficacy.Longer-term follow-up and greater number of patients are necessary to ratify these data.References:[1]Selmi C, et al. BENEFIT: real-world effectiveness of SB4 after transition from reference etanercept in rheumatoid arthritis and axial spondyloarthritis. Clin Exp Rheumatol. 2020 Jun 30. Epub ahead of print.[2]Glintborg B, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019 Feb;78(2):192-200.[3]Tweehuysen L, et al. Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: Six-Month Results From a Controlled Cohort Study. Arthritis Rheumatol. 2018 Sep;70(9):1408-1418.Table 1.WITHDRAWAL (months)BACK TO ENBREL (n)CONTINUEENBREL (n)TIME TO SWITCH (months)REASON FOR WITHDRAWALInefficacyA.event*CancerDeathRA2211853 14521PsA166653,515001SpA888455300TOTAL4625225234822*Infections (1), Heart failure (1), skin reaction (3), injection point reaction (1)RA: rheumatoid arthritis; PsA: psoriatic artrhritis; SpA: spondyloarthritisDisclosure of Interests:None declared
Background:Tocilizumab (TCZ) has shown to be effective for large vessel vasculitis including Takayasu arteritis (TAK) (1-3). Most evidence in TAK comes from Asian patients. However, white patients seem to have different clinical and prognostic features.Objectives:Our aims were to: a) assess the efficacy and safety of TCZ in white patients with refractory TAK, b) determine if clinical improvement correlates with imaging outcomes, c) compare TCZ in monotherapy (TCZMONO) vs combined with conventional immunosuppressive drugs (TCZCOMBO)Methods:Multicenter study of white patients with refractory TAK who received TCZ.Outcomes variables were remission, glucocorticoid-sparing effect, improvement in imaging techniques, and adverse events. A comparative study between patients who received TCZMONO and TCZCOMBO was performed.Results:54 patients (46 women/8 men; median age 42.0 [32.5-50.5] years). TCZ was started after 12.0 [3.0-31.5] months since TAK diagnosis. Remission was achieved in 12/54 (22.2%), 19/49 (38.8%), 23/44 (52.3%) and 27/36 (75%) at 1, 3, 6 and 12 months, respectively. Prednisone dose was reduced from 30.0 [12.5-50.0] to 5.0 [0.0-5.6] mg/day at 12 months (Table 1). 10 (26.3%) of the 38 patients in whom an imaging follow-up test was performed showed no radiographic improvement after a median of 9.0 [6.0-14.0] months. 4 of them were in clinical remission.23 (42.6%) patients were on TCZMONO and 31 (57.4%) on TCZCOMBO: MTX (n=28), cyclosporine A (n=2), azathioprine (n=1). Patients on TCZCOMBO were younger (38.0 [27.0-46.0] vs 45 [38.0-57.0] years; p= 0.048), with a trend to longer TAK duration (21.0 [6.0-38.0] vs 6.0 [1.0-23.0] months; p= 0.08) and higher C-reactive protein (2.4 [0.7-5.6] vs 1.3 [0.3-3.3] mg/dL; p=0.16). Despite these differences, similar outcomes were observed in both groups (log rank p=0.862) (Figure 1). Relevant adverse events were reported in 6 (11.1%) patients, but only 3 developed severe events that required TCZ withdrawal.Table 1.Baselinen=54Month 1N=54Month 3N=49Month 6N=44Month 12N=36Clinical remission, n (%)12 (22.2)19 (38.8)23 (52.3)27 (75.0)Laboratory improvementCRP (mg/dL), median [IQR]1.5 [0.5-3.5]0.2 [0.1-0.7]*0.2 [0.5-0.5]*0.2 [0.1-0.5]*0.1 [0.0-0.4]*ESR (mm/1sthour), median [IQR]30.5 [8.7-52.7]7.0 [3.0-14.0]*4.5 [2.0-8.0]*5.0[2.0-6.0]*4.0 [2.0-9.5]*Hemoglobin (g/dL), mean ± SD12.4 ±1.513.0 ±1.2*13.0 ±1.4*13.2 ±1.5*12.9 ±1.6*Prednisone dose, median [IQR]30.0 [12.5-50.0]20.0 [10.0-30.0]*10.0 [5.0-20.0]*5.0 [5.0-10.5]*5.0 [0.0-5.6]*CRP: C-Reactive Protein; ESR: Erythrocyte Sedimentation Rate; IQR: interquartile range; n: number. *p<0.01 vs baseline (Wilcoxon test).Conclusion:TCZ is effective and safe in white patients with refractory TAK. A discordance between clinical and imaging activity assessment may exist.References:[1]Prieto Peña D et al. Clin Exp Rheumatol 2020 Nov 27. PMID: 33253103.[2]Loricera J, et al. Clin Exp Rheumatol 2016; 34:S44-53. PMID: 27050507.[3]Calderón-Goercke M, et al. Semin Arthritis Rheum 2019; 49:126-35. PMID: 30655091Disclosure of Interests:Diana Prieto-Peña Grant/research support from: DP-P has received research support from UCB Pharma, Roche, Sanofi, Pfizer, AbbVie and Lilly., Pilar Bernabéu: None declared, Paloma Vela-Casasempere: None declared, J. Narváez: None declared, Carlos Fernández-López: None declared, Mercedes Freire González: None declared, Beatriz González-Alvarez: None declared, Roser Solans-Laqué: None declared, Jose Luis Callejas-Rubio: None declared, Norberto Ortego: None declared, Carlos Fernández-Díaz: None declared, Esteban Rubio Romero: None declared, SALVADOR GARCÍA MORILLO: None declared, Mauricio Minguez: None declared, Cristina Fernández-Carballido: None declared, Eugenio de Miguel: None declared, Sheila Melchor: None declared, Eva Salgado-Pérez: None declared, Beatriz Bravo: None declared, Susana Romero-Yuste: None declared, Juan Salvatierra: None declared, Cristina Hidalgo: None declared, Sara Manrique Arija: None declared, C. Romero-Gómez: None declared, Patricia Moya: None declared, Noelia Alvarez-Rivas: None declared, Javier Mendizabal: None declared, Francisco Miguel Ortiz Sanjuan: None declared, I. Pérez de Pedro: None declared, JOSE LUIS ALONSO VALDIVIESO: None declared, Pérez Sánchez Laura: None declared, Roldán Molina Rosa: None declared, Nagore Fernández-Llanio: None declared, Ricardo Gómez de la Torre: None declared, Silvia Suarez: None declared, María Jesús Montesa: None declared, Monica Delgado Sanchez: None declared, J. Loricera: None declared, Belén Atienza-Mateo: None declared, Santos Castañeda: None declared, Miguel A González-Gay Grant/research support from: MAG-G received grants/research supports from Abbvie, MSD, Jansen and Roche and had consultation fees/participation in company sponsored speaker´s bureau from Abbvie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Ricardo Blanco Grant/research support from: RB received grants/research supports from Abbvie, MSD and Roche, and had consultation fees/participation in company sponsored speaker´s bureau from Abbvie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD.
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