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Zeitschrift für Rheumatologie

Erschienen in:

06.09.2018 | Originalien

Comparison of the efficacy and safety of tofacitinib and baricitinib in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials

verfasst von: S.-C. Bae, MD, PhD, Y. H. Lee, MD, PhD

Erschienen in: Zeitschrift für Rheumatologie | Ausgabe 6/2019

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Abstract

Objectives

The relative efficacy and safety of tofacitinib and baricitinib were assessed in patients with rheumatoid arthritis (RA) with an inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) or biologics.

Methods

We performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) to examine the efficacy and safety of tofacitinib and baricitinib in combination with DMARDs in RA patients with an inadequate DMARD or biologic response.

Results

Twelve RCTs including 5883 patients met the inclusion criteria. There were 15 pairwise comparisons including 10 direct comparisons of 6 interventions. Tofacitinib 10 mg + methotrexate (MTX) and baricitinib 4 mg + MTX were among the most effective treatments for active RA with an inadequate DMARD or biologic response, followed by baricitinib 2 mg + MTX, tofacitinib 5 mg + MTX, and adalimumab + MTX. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that tofacitinib 10 mg + MTX had the highest probability of being the best treatment to achieve the ACR20 response rate (SUCRA = 0.865), followed by baricitinib 4 mg + MTX (SUCRA = 0.774), baricitinib 2 mg + MTX (SUCRA = 0.552), tofacitinib 5 mg + MTX (SUCRA = 0.512), adalimumab + MTX (SUCRA = 0.297), and placebo + MTX (SUCRA <0.001). No significant differences were observed in the incidence of serious adverse events after treatment with tofacitinib + MTX, baricitinib + MTX, adalimumab + MTX, or placebo + MTX.

Conclusions

In RA patients with an inadequate response to DMARDs or biologics, tofacitinib 10 mg + MTX and baricitinib 4 mg + MTX were the most efficacious interventions and were not associated with a significant risk of serious adverse events.

Aletaha D, Landewe R, Karonitsch T et al (2008) Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Care Res 59(10):1371–1377

Brown S, Hutton B, Clifford T et al (2014) A Microsoft-Excel-based tool for running and critically appraising network meta-analyses—an overview and application of NetMetaXL. Syst Rev 3(1):110PubMedPubMedCentral

Burmester GR, Benda B, Gruben D et al (2013) Tofacitinib for rheumatoid arthritis—Authors’ reply. Lancet 381(9880):1812–1813PubMed

Caldwell DM, Ades A, Higgins J (2005) Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ 331(7521):897PubMedPubMedCentral

Catalá-López F, Tobías A, Cameron C et al (2014) Network meta-analysis for comparing treatment effects of multiple interventions: an introduction. Rheumatol Int 34(11):1489–1496PubMed

Changelian PS, Flanagan ME, Ball DJ et al (2003) Prevention of organ allograft rejection by a specific Janus kinase 3 inhibitor. Science 302(5646):875–878PubMed

Chrencik JE, Patny A, Leung IK et al (2010) Structural and thermodynamic characterization of the TYK2 and JAK3 kinase domains in complex with CP-690550 and CMP-6. J Mol Biol 400(3):413–433PubMed

Dias S, Welton NJ, Sutton AJ et al (2013) Evidence synthesis for decision making 4 inconsistency in networks of evidence based on randomized controlled trials. Med Decis Making 33(5):641–656PubMedPubMedCentral

Dougados M, van der Heijde D, Chen Y‑C et al (2015) LB0001 Baricitinib, an oral Janus Kinase (JAK) 1/JAK2 inhibitor, in patients with active Rheumatoid Arthritis (RA) and an inadequate response to CDMARD therapy: results of the phase 3 RA-build study. Ann Rheum Dis 74(Suppl 2):79–79

10.

Fleischmann R, Cutolo M, Genovese MC et al (2012) Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum 64(3):617–629PubMed

11.

Fleischmann R, Kremer J, Cush J et al (2012) Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 367(6):495–507PubMed

12.

Fleischmann R, Takeuchi T, Schlichting DE et al (2015) Baricitinib, methotrexate, or baricitinib plus methotrexate in patients with early rheumatoid arthritis who had received limited or no treatment with disease-modifying anti-rheumatic drugs (DMARDs): phase 3 trial results. In: Arthritis & Rheumatology. Wiley-Blackwell, Hoboken

13.

Genovese MC, Kremer J, Zamani O et al (2016) Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med 374(13):1243–1252PubMed

14.

Ghoreschi K, Laurence A, O’Shea JJ (2009) Janus kinases in immune cell signaling. Immunol Rev 228(1):273–287PubMedPubMedCentral

15.

Ghoreschi K, Laurence A, O’Shea JJ (2009) Janus kinases in immune cell signaling. Immunol Rev 228(1):273–287PubMedPubMedCentral

16.

Greenwald M, Fidelus-Gort R, Levy R et al (2010) A randomized dose-ranging, placebo-controlled study of INCB028050, a selective JAK1 and JAK2 inhibitor in subjects with active rheumatoid arthritis. Arthritis Rheum 62(Suppl 10):2172

17.

Higgins J, Jackson D, Barrett J et al (2012) Consistency and inconsistency in network meta-analysis: concepts and models for multi-arm studies. Res Synth Methods 3(2):98–110PubMedPubMedCentral

18.

Hochberg MC, Chang RW, Dwosh I et al (1992) The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 35(5):498–502PubMed

19.

Jadad AR, Moore RA, Carroll D et al (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17(1):1–12PubMed

20.

Keystone EC, Taylor PC, Drescher E et al (2015) 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(2):333–340PubMed

21.

Kremer J, Li ZG, Hall S et al (2013) Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med 159(4):253–261PubMed

22.

Kremer JM, Bloom BJ, Breedveld FC et al (2009) The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum 60(7):1895–1905PubMed

23.

Kremer JM, Cohen S, Wilkinson BE et al (2012) A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum 64(4):970–981PubMed

24.

Kubo S, Yamaoka K, Kondo M et al (2013) The JAK inhibitor, tofacitinib, reduces the T cell stimulatory capacity of human monocyte-derived dendritic cells. Ann Rheum Dis 73:2192–2198PubMed

25.

Lee EB, Fleischmann R, Hall S et al (2014) Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med 370(25):2377–2386PubMed

26.

Lee Y‑H, Bae S‑C, Song G‑G (2012) Omega-3 polyunsaturated fatty acids and the treatment of rheumatoid arthritis: a meta-analysis. Arch Med Res 43(5):356–362PubMed

27.

Lee Y, Bae S‑C (2018) Comparative efficacy and safety of baricitinib 2 mg and 4 mg in patients with active rheumatoid arthritis. Z Rheumatol 77(4):335–342PubMed

28.

Lee Y, Bae S, Song G (2013) Hepatitis B virus (HBV) reactivation in rheumatic patients with hepatitis core antigen (HBV occult carriers) undergoing anti-tumor necrosis factor therapy

29.

Lee YH, Bae S‑C, Song GG (2015) Comparative efficacy and safety of tofacitinib, with or without methotrexate, in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials. Rheumatol Int 35(12):1965–1974PubMed

30.

Meyer DM, Jesson MI, Li X et al (2010) Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm (Lond) 7:41

31.

Moher D, Liberati A, Tetzlaff J et al (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 151(4):264–269PubMed

32.

Norman P (2014) Selective JAK inhibitors in development for rheumatoid arthritis. Expert Opin Investig Drugs 23(8):1067–1077PubMed

33.

Park Y‑W, Kim K‑J, Yang H‑I et al (2017) Comparing effectiveness rituximab (Mabthera®) to other second-line biologics for rheumatoid arthritis treatment in patients refractory to or intolerant of first-line anti-tumor necrosis factor agent: an observational study. J Rheum Dis 24(4):227–235

34.

Roskoski R Jr. (2016) Janus kinase (JAK) inhibitors in the treatment of inflammatory and neoplastic diseases. Pharmacol Res 111:784–803PubMed

35.

Salanti G, Ades A, Ioannidis JP (2011) Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol 64(2):163–171PubMed

36.

Schindler C, Levy DE, Decker T (2007) JAK-STAT signaling: from interferons to cytokines. J Biol Chem 282(28):20059–20063PubMed

37.

Shi JG, Chen X, Lee F et al (2014) The pharmacokinetics, pharmacodynamics, and safety of baricitinib, an oral JAK 1/2 inhibitor, in healthy volunteers. J Clin Pharmacol 54(12):1354–1361PubMed

38.

Smolen JS, Aletaha D, McInnes IB (2016) Rheumatoid arthritis. Lancet 388(10055):2023–2038. https://doi.org/10.1016/S0140-6736(16)30173-8 CrossRefPubMed

39.

Tanaka Y, Emoto K, Cai Z et al (2016) Efficacy and safety of baricitinib in Japanese patients with active rheumatoid arthritis receiving background methotrexate therapy: a 12-week, double-blind, randomized placebo-controlled study. J Rheumatol 43(3):504–511PubMed

40.

Tanaka Y, Suzuki M, Nakamura H et al (2011) Phase II study of tofacitinib (CP-690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Care Res 63(8):1150–1158

41.

Taylor PC, Keystone EC, Van Der Heijde D et al (2015) Baricitinib versus placebo or adalimumab in patients with active rheumatoid arthritis (RA) and an inadequate response to background methotrexate therapy: results of a phase 3 study. In: Arthritis & rheuamtology. Wiley-Blackwell, Hoboken

42.

Traynor K (2012) FDA approves tofacitinib for rheumatoid arthritis. Am J Health Syst Pharm 69(24):2120PubMed

43.

Valkenhoef G, Lu G, Brock B et al (2012) Automating network meta-analysis. Res Synth Methods 3(4):285–299PubMed

44.

van der Heijde D, Tanaka Y, Fleischmann R et al (2013) Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study. Arthritis Rheum 65(3):559–570PubMed

45.

van Vollenhoven RF, Fleischmann R, Cohen S et al (2012) Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 367(6):508–519PubMed

Titel: Comparison of the efficacy and safety of tofacitinib and baricitinib in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials
verfasst von: S.-C. Bae, MD, PhD
Y. H. Lee, MD, PhD
Publikationsdatum: 06.09.2018
Verlag: Springer Medizin
Erschienen in: Zeitschrift für Rheumatologie / Ausgabe 6/2019
Print ISSN: 0340-1855
Elektronische ISSN: 1435-1250
DOI: https://doi.org/10.1007/s00393-018-0531-5

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Comparison of the efficacy and safety of tofacitinib and baricitinib in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials

Abstract

Objectives

Methods

Results

Conclusions

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