Reducing or Maintaining the Dose of Subcutaneous Tocilizumab in Patients With Rheumatoid Arthritis in Clinical Remission: A Randomized, Open-Label Trial

Raimon Sanmarti, Douglas J. Veale, Emilio Martin-Mola, Alejandro Escudero-Contreras, Carlos González, Liliana Ercole, Rocío Alonso, João E. Fonseca, Cristina Alcañiz, José María Álvaro-Gracia, Alejandro Balsa, José Luis de Pablos, Consuelo Díaz Miguel, José Manuel Rodríguez, Jose Alves, Elena Aurrecoechea, Jaime Calvo, Joaquín Belzunegui, Francisco Blanco, Rafael CalizJavier Calvo, José Román Ivorra, Helena Canhão, Helena Santos, Eugenio Chamizo, Javier del Pino, Concepción Delgado, César Díaz, Antonio Fernández Nebro, Alexander Fraser, Antonio Gomez, Blanca Hernández, Federico Navarro, Juan Povedano, Antonio Juan Mas, David Kane, Bryan Whelan, Carlos Marras, Juan Moreno, José Pérez Venegas, Manuel Pombo, Elena Riera, Antonio Rosas, John Ryan, José Santos, Maria Santos, Jesús Tornero, Juan Víctor Tovar, Eduardo Ucar, Carlos Vasconcelos

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7 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy and safety of increasing the dose interval of subcutaneous tocilizumab (TCZ-SC) in patients with rheumatoid arthritis (RA) who are in clinical remission. Methods: RA patients with active disease and an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or to a biologic agent were entered into a single-arm treatment phase with 162 mg of TCZ-SC administered once weekly (TCZ-SC 162 mg qw) as monotherapy or in combination with a csDMARD for 24 weeks. Patients who achieved clinical remission at weeks 20 and 24 were randomized to continue with the same regimen or to switch to 162 mg TCZ-SC administered every 2 weeks (TCZ-SC 162 mg q2w) for 24 weeks (open-label). Patients with a Disease Activity Score in 28 joints (DAS28) of <2.6 were considered to be in clinical remission. Results: In total, 179 (45%) of 401 patients in the single-arm phase achieved clinical remission and were randomized to continue to receive TCZ-SC 162 mg qw (n = 89) or to switch to TCZ-SC 162 mg q2w (n = 90) for 24 weeks. At week 48, significantly more patients treated with TCZ-SC 162 mg qw remained in clinical remission compared to patients who received TCZ-SC 162 mg q2w (90% versus 73%; P = 0.004). The results of other efficacy measures revealed greater efficacy with TCZ-SC 162 mg qw, but none of the efficacy outcomes in this group were significantly different from those in patients treated with TCZ-SC 162 mg q2w, except for the mean change from baseline in the DAS28 score at week 48 (mean change −4.07 points [SD 1.29] versus −3.65 points [SD 1.35]; P = 0.034). Tolerability and safety parameters were similar between the treatment groups. Conclusion: Increasing the dose interval of TCZ-SC in patients with RA was associated with a lower likelihood of maintaining remission after 24 weeks and was not associated with better tolerability. However, most patients were able to sustain remission with a half-dose of TCZ-SC, and therefore this strategy deserves further investigation.

Original languageEnglish
Pages (from-to)1616-1625
Number of pages10
JournalArthritis and Rheumatology
Volume71
Issue number10
DOIs
Publication statusPublished - 1 Oct 2019

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