Retention rate of a second line with a biologic DMARD after failure of a first-line therapy with abatacept, tocilizumab, or rituximab: results from the Italian GISEA registry.


Journal

Clinical rheumatology
ISSN: 1434-9949
Titre abrégé: Clin Rheumatol
Pays: Germany
ID NLM: 8211469

Informations de publication

Date de publication:
Oct 2021
Historique:
received: 02 01 2021
accepted: 07 04 2021
revised: 02 04 2021
pubmed: 22 4 2021
medline: 29 9 2021
entrez: 21 4 2021
Statut: ppublish

Résumé

EULAR recommendations do not suggest which biologic disease-modifying anti-rheumatic drug (bDMARD) should be preferred after failure of a first bDMARD in the treatment of rheumatoid arthritis (RA). In particular, few data are available regarding the effectiveness of a second-line bDMARD after failure of abatacept (ABA), tocilizumab (TCZ), and rituximab (RTX). The aim of this study was to analyze the retention rate of a second line with tumor necrosis factor inhibitors (TNFi) or other mechanisms of action (MoAs), after the failure of either RTX, TCZ, or ABA. Two hundred and seventy-eight RA patients from the Italian GISEA registry were included in the study. RTX was the first bDMARD in 18% of patients, ABA in 45.7%, and TCZ in 36.3%, while the second bDMARD was a TNFi (group 1) in 129 patients and an agent with a different MoA (group 2) in 149. During a median follow-up of 22 months (IQR 68), 129 patients discontinued their treatment; patients of group 1 discontinued the treatment more frequently than patients of group 2 (p<0.001) with retention rates of 33.6±5.7% and 63.6±4.6% after 104 weeks for group 1 and group 2, respectively (p<0.001). At multivariate analysis, the mechanism of action was the only predictor for the maintenance in therapy. According to our data, ABA, RTX, and TCZ seem to maintain a good retention rate also when used as a second-line therapy, suggesting their use after the failure of a non-TNFi as first-line therapy. However, specifically designed studies are needed to evaluate the more appropriate therapeutic strategies in RA, according to the first-line drug, including new targeted synthetic DMARDs. Key Points • A large proportion of rheumatoid arthritis patients fail the first biologic DMARD. • Few data are available about the efficacy of biologic DMARD after the failure of a non-TNF inhibitor. • Abatacept, rituximab, or tocilizumab seem to maintain a good retention rate after the failure of a first-course therapy with a non-TNF inhibitor.

Identifiants

pubmed: 33881676
doi: 10.1007/s10067-021-05734-3
pii: 10.1007/s10067-021-05734-3
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Antirheumatic Agents 0
Biological Products 0
Rituximab 4F4X42SYQ6
Abatacept 7D0YB67S97
tocilizumab I031V2H011

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

4039-4047

Investigateurs

Elena Galli (E)
Francesco Paolo Cantatore (FP)
Claudia Lomater (C)
Fabiola Atzeni (F)
Roberto Gorla (R)
Enrico Fusaro (E)
Fausto Salaffi (F)
Fabrizio Conti (F)
Alberto Cauli (A)
Piercarlo Sarzi-Puttini (P)
Antonio Carletto (A)
Giuseppe Lopalco (G)

Informations de copyright

© 2021. International League of Associations for Rheumatology (ILAR).

Références

Epstein FH, Harris ED (1990) Rheumatoid arthritis. N Engl J Med 322:1277–1289
doi: 10.1056/NEJM199005033221805
Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP (2008) Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 117:244–279
doi: 10.1016/j.pharmthera.2007.10.001
Keystone EC (2004) Safety issues related to emerging therapies for rheumatoid arthritis. Clin Exp Rheumatol 22:S148–S150
pubmed: 15552529
Lipsky PE, van der Heijde DM, St Clair EW et al (2000) Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 343:1594–1602
doi: 10.1056/NEJM200011303432202
Schiff MH, von Kempis J, Goldblum R, Tesser JR, Mueller RB (2014) Rheumatoid arthritis secondary non-responders to TNF can attain an efficacious and safe response by switching to certolizumab pegol: a phase IV, randomised, multicentre, double-blind, 12-week study, followed by a 12-week open-label phase. Ann Rheum Dis 73:2174–2177
doi: 10.1136/annrheumdis-2014-205325
Pierreisnard A, Issa N, Barnetche T, Richez C, Schaeverbeke T (2013) Meta-analysis of clinical and radiological efficacy of biologics in rheumatoid arthritis patients naive or inadequately responsive to methotrexate. Jt Bone Spine 80:386–392
doi: 10.1016/j.jbspin.2012.09.023
Jobanputra P, Maggs F, Deeming A, Carruthers D, Rankin E, Jordan AC, Faizal A, Goddard C, Pugh M, Bowman SJ, Brailsford S, Nightingale P (2012) A randomised efficacy and discontinuation study of etanercept versus adalimumab (RED SEA) for rheumatoid arthritis: a pragmatic, unblinded, non-inferiority study of first TNF inhibitor use: outcomes over 2 years. BMJ Open 2:e001395
doi: 10.1136/bmjopen-2012-001395
Favalli EG, Bugatti S, Biggioggero M, Caporali R (2014) Treatment comparison in rheumatoid arthritis: head-to-head trials and innovative study designs. Biomed Res Int 2014:831603
doi: 10.1155/2014/831603
Smolen JS, Landewé R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, Nam J, Ramiro S, Voshaar M, van Vollenhoven R, Aletaha D, Aringer M, Boers M, Buckley CD, Buttgereit F, Bykerk V, Cardiel M, Combe B, Cutolo M, van Eijk-Hustings Y, Emery P, Finckh A, Gabay C, Gomez-Reino J, Gossec L, Gottenberg JE, Hazes JMW, Huizinga T, Jani M, Karateev D, Kouloumas M, Kvien T, Li Z, Mariette X, McInnes I, Mysler E, Nash P, Pavelka K, Poór G, Richez C, van Riel P, Rubbert-Roth A, Saag K, da Silva J, Stamm T, Takeuchi T, Westhovens R, de Wit M, van der Heijde D (2017) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 76:960–977
doi: 10.1136/annrheumdis-2016-210715
Østergaard M, Unkerskov J, Linde L, Krogh NS, Ravn T, Ringsdal VS, Petri A, Andersen LS, Tarp U, Hansen A, Hjardem E, Hetland ML (2007) Low remission rates but long drug survival in rheumatoid arthritis patients treated with infliximab or etanercept: results from the nationwide Danish DANBIO database. Scand J Rheumatol 36:151–154
doi: 10.1080/03009740601089267
Janke K, Biester K, Krause D et al (2020) Comparative effectiveness of biological medicines in rheumatoid arthritis: systematic review and network meta-analysis including aggregate results from reanalysed individual patient data. BMJ 370:m2288
doi: 10.1136/bmj.m2288
Grabner M, Boytsov NN, Huang Q, Zhang X, Yan T, Curtis JR (2017) Costs associated with failure to respond to treatment among patients with rheumatoid arthritis initiating TNFi therapy: a retrospective claims analysis. Arthritis Res Ther 19:92
doi: 10.1186/s13075-017-1293-1
Karpes Matusevich AR, Suarez-Almazor ME, Cantor SB, Lal LS, Swint JM, Lopez-Olivo MA (2020) Systematic review of economic evaluations of cycling versus swapping medications in patients with rheumatoid arthritis after failure to respond to tumor necrosis factor inhibitors. Arthritis Care Res 72:343–352
doi: 10.1002/acr.23859
Todoerti M, Favalli EG, Iannone F et al (2018) Switch or swap strategy in rheumatoid arthritis patients failing TNF inhibitors? Results of a modified Italian Expert Consensus. Rheumatology 57:vii42–vii53
doi: 10.1093/rheumatology/key195
Lapadula G, Ferraccioli G, Ferri C, Punzi L, Trotta F, GISEA (2011) GISEA: an Italian biological agents registry in rheumatology. Reumatismo 63:155–164
doi: 10.4081/reumatismo.2011.155
Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO III, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JMW, Hobbs K, Huizinga TWJ, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Ménard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovský J, Wolfe F, Hawker G (2010) 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 62:2569–2581
doi: 10.1002/art.27584
Chan W (2013) Statistical methods in medical research. Model Assist Stat Appl 8:83–84
Akiyama M, Kaneko Y, Kondo H, Takeuchi T (2016) Comparison of the clinical effectiveness of tumour necrosis factor inhibitors and abatacept after insufficient response to tocilizumab in patients with rheumatoid arthritis. Clin Rheumatol 35:2829–2834
doi: 10.1007/s10067-016-3227-8
Henaux S, Ruyssen-Witrand A, Cantagrel A, Barnetche T, Fautrel B, Filippi N, Lukas C, Raffeiner B, Rossini M, Degboé Y, Constantin A (2018) Risk of losing remission, low disease activity or radiographic progression in case of bDMARD discontinuation or tapering in rheumatoid arthritis: systematic analysis of the literature and meta-analysis. Ann Rheum Dis 77:515–522
doi: 10.1136/annrheumdis-2017-212423
Singh JA, Saag KG, Bridges SL et al (2016) 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res 68:1–25
doi: 10.1002/acr.22783
Gottenberg J-E, Brocq O, Perdriger A, Lassoued S, Berthelot JM, Wendling D, Euller-Ziegler L, Soubrier M, Richez C, Fautrel B, Constantin AL, Mariette X, Morel J, Gilson M, Cormier G, Salmon JH, Rist S, Lioté F, Marotte H, Bonnet C, Marcelli C, Sellam J, Meyer O, Solau-Gervais E, Guis S, Ziza JM, Zarnitsky C, Chary-Valckenaere I, Vittecoq O, Saraux A, Pers YM, Gayraud M, Bolla G, Claudepierre P, Ardizzone M, Dernis E, Breban MA, Fain O, Balblanc JC, Aberkane O, Vazel M, Back C, Candon S, Chatenoud L, Perrodeau E, Sibilia J, Ravaud P (2016) Non–TNF-targeted biologic vs a second anti-TNF drug to treat rheumatoid arthritis in patients with insufficient response to a first anti-TNF drug. JAMA 316:1172–1180
doi: 10.1001/jama.2016.13512
Kobayakawa T, Kojima T, Takahashi N, Hayashi M, Yabe Y, Kaneko A, Shioura T, Saito K, Hirano Y, Kanayama Y, Miyake H, Asai N, Funahashi K, Hirabara S, Hanabayashi M, Asai S, Ishiguro N (2015) Drug retention rates of second biologic agents after switching from tumor necrosis factor inhibitors for rheumatoid arthritis in Japanese patients on low-dose methotrexate or without methotrexate. Mod Rheumatol 25:251–256
doi: 10.3109/14397595.2014.953668
Du Pan SM, Scherer A, Gabay C, Finckh A (2012) Differential drug retention between anti-TNF agents and alternative biological agents after inadequate response to an anti-TNF agent in rheumatoid arthritis patients. Ann Rheum Dis 71:997–999
doi: 10.1136/annrheumdis-2011-200882
Gomez-Reino JJ, Maneiro JR, Ruiz J, Roselló R, Sanmarti R, Romero AB, MIRAR Study Group (2012) Comparative effectiveness of switching to alternative tumour necrosis factor (TNF) antagonists versus switching to rituximab in patients with rheumatoid arthritis who failed previous TNF antagonists: the MIRAR Study. Ann Rheum Dis 71:1861–1864
doi: 10.1136/annrheumdis-2012-201324
Emery P, Gottenberg JE, Rubbert-Roth A, Sarzi-Puttini P, Choquette D, Martínez Taboada VM, Barile-Fabris L, Moots RJ, Ostor A, Andrianakos A, Gemmen E, Mpofu C, Chung C, Gylvin LH, Finckh A (2015) Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study. Ann Rheum Dis 74:979–984
doi: 10.1136/annrheumdis-2013-203993
Malottki K, Barton P, Tsourapas A, Uthman AO, Liu Z, Routh K, Connock M, Jobanputra P, Moore D, Fry-Smith A, Chen YF (2011) Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a tumour necrosis factor inhibitor: a systematic review and economic evaluation. Health Technol Assess 15:1–278
doi: 10.3310/hta15140
Lauper K, Mongin D, Iannone F, Kristianslund EK, Kvien TK, Nordström DC, Pavelka K, Pombo-Suarez M, Rotar Z, Santos MJ, Codreanu C, Lukina G, Gale SL, John M, Luder Y, Courvoisier DS, Gabay C (2020) Comparative effectiveness of TNF inhibitors and tocilizumab with and without conventional synthetic disease-modifying antirheumatic drugs in a pan-European observational cohort of bio-naïve patients with rheumatoid arthritis. Semin Arthritis Rheum 50:17–24
doi: 10.1016/j.semarthrit.2019.06.020
Vial G, De Pouilly A, Scouppe L et al (2020) Factors influencing the choice of biologic therapy following rituximab in patients with rheumatoid arthritis: a retrospective study using propensity score. Jt Bone Spine 87:43–48
doi: 10.1016/j.jbspin.2019.07.008
Walker UA, Jaeger VK, Chatzidionysiou K, Hetland ML, Hauge EM, Pavelka K, Nordström DC, Canhão H, Tomšič M, van Vollenhoven R, Gabay C (2016) Rituximab done: what’s next in rheumatoid arthritis? A European observational longitudinal study assessing the effectiveness of biologics after rituximab treatment in rheumatoid arthritis. Rheumatology 55:230–236
doi: 10.1093/rheumatology/kev297
Das S, Vital EM, Horton S, Bryer D, el-Sherbiny Y, Rawstron AC, Ponchel F, Emery P, Buch MH (2014) Abatacept or tocilizumab after rituximab in rheumatoid arthritis? An exploratory study suggests non-response to rituximab is associated with persistently high IL-6 and better clinical response to IL-6 blocking therapy. Ann Rheum Dis 73:909–912
doi: 10.1136/annrheumdis-2013-204417
Gaujoux-Viala C, Gossec L, Cantagrel A, Dougados M, Fautrel B, Mariette X, Nataf H, Saraux A, Trope S, Combe B, French Society for Rheumatology (2014) Recommendations of the French Society for Rheumatology for managing rheumatoid arthritis. Jt Bone Spine 81:287–297
doi: 10.1016/j.jbspin.2014.05.002
Monti S, Klersy C, Gorla R, Sarzi-Puttini P, Atzeni F, Pellerito R, Fusaro E, Paolazzi G, Rocchetta PA, Favalli EG, Marchesoni A, Caporali R (2017) Factors influencing the choice of first- and second-line biologic therapy for the treatment of rheumatoid arthritis: real-life data from the Italian LORHEN Registry. Clin Rheumatol 36:753–761
doi: 10.1007/s10067-016-3528-y
Alemao E, Postema R, Elbez Y, Mamane C, Finckh A (2020) Presence of anti-cyclic citrullinated peptide antibodies is associated with better treatment response to abatacept but not to TNF inhibitors in patients with rheumatoid arthritis: a meta-analysis. Clin Exp Rheumatol 38:455–466
pubmed: 31770089
Conigliaro P, Triggianese P, Chimenti MS, Lucchetti R, Kroegler B, Perricone R (2016) Serological markers associated with disease activity in patients with rheumatoid arthritis treated with rituximab. J Int Med Res 44:53–57
doi: 10.1177/0300060515593240
Bendtzen K, Geborek P, Svenson M, Larsson L, Kapetanovic MC, Saxne T (2006) Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor α inhibitor infliximab. Arthritis Rheum 54:3782–3789
doi: 10.1002/art.22214
Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, Dijkmans BAC, Tak PP, Wolbink GJ (2007) Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 66:921–926
doi: 10.1136/ard.2006.065615

Auteurs

Marco Sebastiani (M)

Rheumatology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria Policlinico di Modena, Via del Pozzo, 41125, Modena, Italy. marco.sebastiani@unimore.it.

Vincenzo Venerito (V)

Department of Emergency and Organ Transplantation, Rheumatology Unit, University of Bari, Bari, Italy.

Serena Bugatti (S)

Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, University of Pavia, Pavia, Italy.

Chiara Bazzani (C)

Unit of Rheumatology and Clinical Immunology, ASST Spedali Civili, Brescia, Italy.

Martina Biggioggero (M)

Department of Rheumatology, Gaetano Pini Institute, Milan, Italy.

Luca Petricca (L)

Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy.

Rosario Foti (R)

Rheumatology Unit, A.O.U. Policlinico San Marco, Catania, Italy.

Alessandra Bortoluzzi (A)

Section of Rheumatology, Department of Medical Sciences, University of Ferrara and Azienda Ospedaliera-Universitaria di Ferrara, Ferrara, Italy.

Silvia Balduzzi (S)

Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, University of Pavia, Pavia, Italy.

Elisa Visalli (E)

Rheumatology Unit, A.O.U. Policlinico San Marco, Catania, Italy.

Bruno Frediani (B)

Rheumatology Unit, Department of Medical Sciences, Surgery e Neurosciences, University of Siena, Siena, Italy.

Andreina Manfredi (A)

Rheumatology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria Policlinico di Modena, Via del Pozzo, 41125, Modena, Italy.

Elisa Gremese (E)

Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy.

Ennio Favalli (E)

Department of Rheumatology, Gaetano Pini Institute, Milan, Italy.

Florenzo Iannone (F)

Department of Emergency and Organ Transplantation, Rheumatology Unit, University of Bari, Bari, Italy.

Gianfranco Ferraccioli (G)

Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy.

Giovanni Lapadula (G)

Department of Emergency and Organ Transplantation, Rheumatology Unit, University of Bari, Bari, Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH