OBJECTIVE: To assess the efficacy and safety of anakinra (ANK) as an add-on therapy in RA patients with inadequate response to monotherapy with non-biological DMARDs. METHODS: A 48-week comparative, prospective study of patients with active RA [mean 28-joint disease activity score (DAS28): 6.81], despite MTX (n = 48), or LEF (n = 42), or CSA (n = 38) treatment, in whom ANK (100 mg/daily SC) was given with corticosteroid cream topical application. RESULTS: At 24 and 48 weeks the patient percentages meeting the ACR20 response criteria were 57 and 73%, respectively, 33 and 41% met ACR50, while 15 and 23% met ACR70. Significant improvements in number of swollen and tender joints, HAQ, pain, global disease assessment, CRP and haemoglobin from baseline to 24 and 48 weeks were evident. DAS28 decreased at 24 weeks (- 1.68; 95% CI - 1.46, - 1.90; P < 0.0001), as well as at study end (- 2.24; 95% CI - 2.01, - 2.47; P < 0.0001). Subgroup analysis revealed a significantly weaker response in terms of pain and DAS28 in patients treated with concomitant CSA. The most common ANK-related adverse event was injection-site reaction (29%), being less frequent in male patients, as well as in patients treated with CSA. There were 17 withdrawals, 6 of them due to inefficacy. No opportunistic infections or new safety signals were observed. CONCLUSION: Considering the limitations of an open-label study, addition of ANK appears to be an effective and well-tolerated treatment option for many RA patients with inadequate responses to non-biologic DMARDs in clinical practice.
OBJECTIVE: To assess the efficacy and safety of anakinra (ANK) as an add-on therapy in RApatients with inadequate response to monotherapy with non-biological DMARDs. METHODS: A 48-week comparative, prospective study of patients with active RA [mean 28-joint disease activity score (DAS28): 6.81], despite MTX (n = 48), or LEF (n = 42), or CSA (n = 38) treatment, in whom ANK (100 mg/daily SC) was given with corticosteroid cream topical application. RESULTS: At 24 and 48 weeks the patient percentages meeting the ACR20 response criteria were 57 and 73%, respectively, 33 and 41% met ACR50, while 15 and 23% met ACR70. Significant improvements in number of swollen and tender joints, HAQ, pain, global disease assessment, CRP and haemoglobin from baseline to 24 and 48 weeks were evident. DAS28 decreased at 24 weeks (- 1.68; 95% CI - 1.46, - 1.90; P < 0.0001), as well as at study end (- 2.24; 95% CI - 2.01, - 2.47; P < 0.0001). Subgroup analysis revealed a significantly weaker response in terms of pain and DAS28 in patients treated with concomitant CSA. The most common ANK-related adverse event was injection-site reaction (29%), being less frequent in male patients, as well as in patients treated with CSA. There were 17 withdrawals, 6 of them due to inefficacy. No opportunistic infections or new safety signals were observed. CONCLUSION: Considering the limitations of an open-label study, addition of ANK appears to be an effective and well-tolerated treatment option for many RApatients with inadequate responses to non-biologic DMARDs in clinical practice.
Authors: Jurgen Sota; Antonio Vitale; Antonella Insalaco; Paolo Sfriso; Giuseppe Lopalco; Giacomo Emmi; Marco Cattalini; Raffaele Manna; Rolando Cimaz; Roberta Priori; Rosaria Talarico; Ginevra de Marchi; Micol Frassi; Romina Gallizzi; Alessandra Soriano; Maria Alessio; Daniele Cammelli; Maria Cristina Maggio; Stefano Gentileschi; Renzo Marcolongo; Francesco La Torre; Claudia Fabiani; Serena Colafrancesco; Francesca Ricci; Paola Galozzi; Ombretta Viapiana; Elena Verrecchia; Manuela Pardeo; Lucia Cerrito; Elena Cavallaro; Alma Nunzia Olivieri; Giuseppe Paolazzi; Gianfranco Vitiello; Armin Maier; Elena Silvestri; Chiara Stagnaro; Guido Valesini; Marta Mosca; Salvatore de Vita; Angela Tincani; Giovanni Lapadula; Bruno Frediani; Fabrizio De Benedetti; Florenzo Iannone; Leonardo Punzi; Carlo Salvarani; Mauro Galeazzi; Rossella Angotti; Mario Messina; Gian Marco Tosi; Donato Rigante; Luca Cantarini Journal: Clin Rheumatol Date: 2018-05-17 Impact factor: 2.980
Authors: Christina Kaiser; Ann Knight; Dan Nordström; Tom Pettersson; Jonas Fransson; Ebba Florin-Robertsson; Björn Pilström Journal: Rheumatol Int Date: 2011-09-01 Impact factor: 2.631
Authors: Giovanny Hernandez; Taylor S Mills; Jennifer L Rabe; James S Chavez; Susan Kuldanek; Gregory Kirkpatrick; Leila Noetzli; Widian K Jubair; Michelle Zanche; Jason R Myers; Brett M Stevens; Courtney J Fleenor; Biniam Adane; Charles A Dinarello; John Ashton; Craig T Jordan; Jorge Di Paola; James R Hagman; V Michael Holers; Kristine A Kuhn; Eric M Pietras Journal: Haematologica Date: 2019-05-17 Impact factor: 9.941