Journal Information
Vol. 18. Issue 3.
Pages 188-189 (March 2022)
Vol. 18. Issue 3.
Pages 188-189 (March 2022)
Letter to the Editor
Full text access
Efficacy and Safety of Baricitinib in Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic DMARDs and/or Biological DMARDs: Data from a Local Registry
Eficacia y seguridad de baricitinib en pacientes con artritis reumatoide y respuesta inadecuada a FAME convencionales sintéticos o biológicos: datos de un registro local
Visits
2153
José Rosasa,b,c,
Corresponding author
j.rosas.gs@gmail.com

Corresponding author.
, José Miguel Senabre-Gallegoa,b,c, Gregorio Santos-Solera,b,c, José Antonio Bernala,b,c, Ana Pons Basa,b,c, Grupo Aire-Mb
a Sección de Reumatología, Hospital Marina Baixa, Villajoyosa, Alicante, Spain
b Sección de Enfermedades Infecciosas, Hospital General Universitario de Elche, Alicante, Spain
c CIO-Universidad Miguel Hernández, Elche, Alicante, Spain
This item has received
Article information
Full Text
Bibliography
Download PDF
Statistics
Tables (1)
Table 1. Patients treated with BARI as D1 or D2-D5: DAS28-ESR and mean CDAI baseline and at last visit. Ten patients were excluded: 8because they came from clinical trials and two due to treatment with BARI < 1 month.
Full Text
Dear Editor,

Intracellular JAK inhibitors (JAKi) are a new group of drugs, effective orally, for the treatment of rheumatoid arthritis (RA). They work at the intracellular level by inhibiting several group I and II cytokines.1 Although, in general, the increase in infections is similar to that of other biological drugs, there appears to be a higher incidence of herpes zoster infection, in particular related to age and steroid treatment.2

Baricitinib (BARI) is a selective JAK1-JAK2 inhibitor that, when administered as a single daily dose, has been shown to be effective and safe in clinical trials in patients with RA who have not responded to conventional synthetic disease modifying drugs (csDMARDs) or biological drugs (bDMARDs).3–7 However, there is little information in patients from clinical practice.8–11

The aim of this study, conducted in a real-life situation, was to determine the response to BARI in patients with inadequate response to csDMARDs or bDMARDs.

From October 2017 to June 2019 we collected patient characteristics (age, gender, comorbidity, BMI), characteristics of RA and of treatment when starting BARI and at the last recorded visit (disease duration, RF and ACPA, DAS28-ESR and CDAI, previous or concomitant treatment with FAMEcs or FAMEb, time on BARI, reason for discontinuation of treatment, severe adverse effects).

Of 230 RA patients in our centre who received a bDMARD or JAKi, 50 (22%) were treated with BARI. Eighty-four percent were female, with a mean age of 59 ± 10.5 years, the mean BMI was 28.3 ± 7 and mean duration of RA was 10.5 ± 8.5 years (range: 1–39 years). The RF and ACPA were positive at 80% and 82% respectively. Forty-seven (94%) patients received a concomitant csDMARD: methotrexate: 28 (56%), leflunomide: 15 (30%), hydroxychloroquine: 3 (6%), and salazopyrin: one (2%). At the start of treatment with BARI 23 (57%) patients were treated with prednisone daily (mean: 7.2 ± 4.7 mg; median: 5 mg; range: 2.5–20 mg).

BARI was the first drug after failure of a csDMARD (F1) in 27 (54%) patients, and after failure of a bDMARD in 23 (46%): the second drug (D2) in 4 (8%), third (D3) in 6 (12%), fourth (D4) in 8 (16%) and fifth (D5) in 5 (10%) patients.

For the analysis, during time under treatment with BARI, 10 patients were discarded: 8 because they came from clinical trials and 2 because they had been under treatment for less than a month, leaving 20 patients in the D1 group and 20 patients in the D2-D5 group. The overall average time on BARI was 9.6 ± 3.2 months, and D1, D2, D3, D4, D5, at 7.5, 7, 7.4, 7.7 and 11 months, respectively. The average time on BARI was 5.4 months. It was discontinued in 10/40 (25%) patients: in 5 (12.5%) patients due to loss of effectiveness, in 4 (10%) due to complications and in one (2.5%) patient due to transfer home.

When comparing patients treated with BARI as D1 versus group D2-D5, significant differences were detected in the mean duration of RA (7.1 ± 6.8 vs. 14.3 ± 8.5, P = .003). Of the D2-D5 patients, prior to starting on BARI, 9 (45%) D2 patients had failed to achieve one therapeutic target (TT), 8 (40%) D3 patients had failed to achieve 2 TT, and 3 (15%) D4-D5 patients had failed to achieve 3 TT. When comparing the results of DAS-ESR and CDAI from the baseline visit and the last visit, significant differences were obtained in all groups (Table 1).

Table 1.

Patients treated with BARI as D1 or D2-D5: DAS28-ESR and mean CDAI baseline and at last visit. Ten patients were excluded: 8because they came from clinical trials and two due to treatment with BARI < 1 month.

  [0,2–3]DAS28-ESRP  [0,5–6]CDAIP 
  Baseline  Last visit    Baseline  Last visit   
BARI D1  5.1  2.6  .0001  23.3  5.5  .001 
BARI D2-D5  5.6  3.2  .0001  29.8  8.8  .001 

BARI treatment was discontinued in 4 (20%) patients: 2 due to herpes zoster (one 58-year-old patient, on treatment with 2.5 mg of prednisone daily; one 71-year-old patient without corticoid treatment; both on methotrexate treatment at a dose of 15 mg weekly), one patient due to anaemia with haemoglobin less than 8 g/dL and the remaining patient due to increased transaminases, not controlled by reducing the BARI dose to 2 mg. During the time of the study, none of the patients presented a thrombotic event.

In this real-life study BARI was effective and safe. It can achieve clinical remission or low disease activity even in patients who have previously failed with various bDMARDs or several therapeutic targets. BARI losses of 20% in the first year of treatment usually occur in the first six months of treatment.

Conflict of interests

J Rosas has participated in consultancies with Janssen, Lilly and has received honoraria for talks from: Abbvie, Celgene, Lilly, MSD, Novartis, Pfizer. JM Senabre-Gallego has received honoraria for talks from: Janssen, Novartis, Pfizer. JA Bernal has received honoraria for talks from: Grünenthal, Pfizer. G Santos-Soler, has received honoraria for talks from: Grünenthal, Pfizer.

A Pons-Bas has no conflict of interests to declare.

Acknowledgements

The study was supported by a research grant from the Asociación para la Investigación en Reumatología de la Marina Baixa (AIRE-MB).

References
[1]
K. Bechman, S. Subesinghe, S. Norton, F. Atzeni, M. Galli, A.P. Cope, et al.
A systematic review and meta-analysis of infection risk with small molecule JAK inhibitors in rheumatoid arthritis.
Rheumatology., 58 (2019), pp. 1755-1766
[2]
J.R. Curtis, F. Xie, S. Yang, S. Bernatsky, L. Chen, H. Yun, et al.
Herpes Zoster in Tofacitinib: risk is further increased with glucocorticoids but not methotrexate.
Arthritis Care Res (Hoboken)., 71 (2019), pp. 1249-1254
[3]
J.J. O’shea, S.M. Holland, L.M. Staudt.
JAKs and STATs in immunity, immunodeficiency, and cancer.
N Engl J Med., 368 (2013), pp. 161-170
[4]
S. Kubo, S. Nakayamada, Y. Tanaka.
Baricitinib for the treatment of rheumatoid arthritis.
Expert Rev Clin Immunol., 12 (2016), pp. 911-919
[5]
E.C. Keystone, P.C. Taylor, E. Drescher, D.E. Schlichting, S.D. Beattie, P.Y. Berclaz, et al.
Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate.
Ann Rheum Dis., 74 (2015), pp. 333-340
[6]
M.C. Genovese, J. Kremer, O. Zamani, C. Ludivico, M. Krogulec, L. Xie, et al.
Baricitinib in patients with refractory rheumatoid arthritis.
N Engl J Med., 374 (2016), pp. 1243-1252
[7]
P.C. Taylor, E.C. Keystone, D. Van Der Heijde, M.E. Weinblatt, L. Del Carmen Morales, J. Reyes Gonzaga, et al.
Baricitinib versus placebo or adalimumab in rheumatoid arthritis.
N Engl J Med., 376 (2017), pp. 652-662
[8]
R van Vollenhoven, C Helt, V Arora, J. Zhong, A.P. Correia, I. de la Torre, et al.
Safety and efficacy of baricitinib in patients receiving conventional synthetic disease-modifying antirheumatic drugs or corticosteroids.
Rheumatol Ther., 5 (2018), pp. 525-536
[9]
J.S. Smolen, M.C. Genovese, T. Takeuchi, D.L. Hyslop, W.L. Macias, T. Rooney, et al.
Safety profile of baricitinib in patients with active rheumatoid arthritis with over 2 years median time in treatment.
J Rheumatol., 46 (2019), pp. 7-18
[10]
J. Tan, S. Davies, S. Linton.
E061. Retrospective cohort study of early real-life experience with baricitinib in rheumatoid arthritis.
[11]
J. Fitton, S. Dass, P. Emery, J. Nam, H.B. Maya.
087. Janus kinase inhibitors demonstrate effectiveness in a real-world multi-biologic DMARD refractory rheumatoid arthritis population.

Please cite this article as: Rosas J, Senabre-Gallego JM, Santos-Soler G, Antonio Bernal J, Pons Bas A, Grupo Aire-Mb. Eficacia y seguridad de baricitinib en pacientes con artritis reumatoide y respuesta inadecuada a FAME convencionales sintéticos o biológicos: datos de un registro local. Reumatol Clin. 2022;18:188–189.

Copyright © 2020. Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología
Idiomas
Reumatología Clínica (English Edition)
Article options
Tools
es en

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?