Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis

Roy M Fleischmann, Tom W J Huizinga, Arthur F Kavanaugh, Bethanie Wilkinson, Kenneth Kwok, Ryan DeMasi, Ronald F van Vollenhoven

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

INTRODUCTION: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib monotherapy was previously shown to inhibit structural damage, reduce clinical signs and symptoms of RA, and improve physical functioning over 24 months in methotrexate (MTX)-naive adult patients with RA. In this post hoc analysis, we compared efficacy and safety of tofacitinib in patients with early (disease duration <1 year) versus established (≥1 year) RA.

METHODS: MTX-naive patients ≥18 years with active RA received tofacitinib monotherapy (5 or 10 mg two times a day, or MTX monotherapy, in a 24-month Phase 3 trial.

RESULTS: Of 956 patients (tofacitinib 5 mg two times a day, n=373; tofacitinib 10 mg two times a day, n=397; MTX, n=186), 54% had early RA. Baseline disease activity and functional disability were similar in both groups; radiographic damage was greater in patients with established RA. At month 24, clinical response rates were significantly greater in patients with early versus established RA in the tofacitinib 5 mg two times a day group. Both tofacitinib doses had greater effects on clinical, functional and radiographic improvements at 1 and 2 years compared with MTX, independent of disease duration. No new safety signals were observed.

CONCLUSIONS: Treatment response was generally similar in early and established RA; significantly greater improvements were observed at month 24 with tofacitinib 5 mg two times a day in early versus established RA. Tofacitinib 5 and 10 mg two times a day demonstrated greater efficacy versus MTX irrespective of disease duration. No difference in safety profiles was observed between patients with early or established RA.

TRIAL REGISTRATION NUMBER: NCT01039688; Results.

Original languageEnglish
Pages (from-to)e000262
JournalRMD Open
Volume2
Issue number2
DOIs
Publication statusPublished - 2016

Cite this

Fleischmann, Roy M ; Huizinga, Tom W J ; Kavanaugh, Arthur F ; Wilkinson, Bethanie ; Kwok, Kenneth ; DeMasi, Ryan ; van Vollenhoven, Ronald F. / Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. In: RMD Open. 2016 ; Vol. 2, No. 2. pp. e000262.
@article{a6f4b265fca943028c7b403337124fa7,
title = "Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis",
abstract = "INTRODUCTION: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib monotherapy was previously shown to inhibit structural damage, reduce clinical signs and symptoms of RA, and improve physical functioning over 24 months in methotrexate (MTX)-naive adult patients with RA. In this post hoc analysis, we compared efficacy and safety of tofacitinib in patients with early (disease duration <1 year) versus established (≥1 year) RA.METHODS: MTX-naive patients ≥18 years with active RA received tofacitinib monotherapy (5 or 10 mg two times a day, or MTX monotherapy, in a 24-month Phase 3 trial.RESULTS: Of 956 patients (tofacitinib 5 mg two times a day, n=373; tofacitinib 10 mg two times a day, n=397; MTX, n=186), 54{\%} had early RA. Baseline disease activity and functional disability were similar in both groups; radiographic damage was greater in patients with established RA. At month 24, clinical response rates were significantly greater in patients with early versus established RA in the tofacitinib 5 mg two times a day group. Both tofacitinib doses had greater effects on clinical, functional and radiographic improvements at 1 and 2 years compared with MTX, independent of disease duration. No new safety signals were observed.CONCLUSIONS: Treatment response was generally similar in early and established RA; significantly greater improvements were observed at month 24 with tofacitinib 5 mg two times a day in early versus established RA. Tofacitinib 5 and 10 mg two times a day demonstrated greater efficacy versus MTX irrespective of disease duration. No difference in safety profiles was observed between patients with early or established RA.TRIAL REGISTRATION NUMBER: NCT01039688; Results.",
keywords = "Journal Article",
author = "Fleischmann, {Roy M} and Huizinga, {Tom W J} and Kavanaugh, {Arthur F} and Bethanie Wilkinson and Kenneth Kwok and Ryan DeMasi and {van Vollenhoven}, {Ronald F}",
year = "2016",
doi = "10.1136/rmdopen-2016-000262",
language = "English",
volume = "2",
pages = "e000262",
journal = "RMD Open",
issn = "2056-5933",
publisher = "BMJ Publishing Group",
number = "2",

}

Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. / Fleischmann, Roy M; Huizinga, Tom W J; Kavanaugh, Arthur F; Wilkinson, Bethanie; Kwok, Kenneth; DeMasi, Ryan; van Vollenhoven, Ronald F.

In: RMD Open, Vol. 2, No. 2, 2016, p. e000262.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis

AU - Fleischmann, Roy M

AU - Huizinga, Tom W J

AU - Kavanaugh, Arthur F

AU - Wilkinson, Bethanie

AU - Kwok, Kenneth

AU - DeMasi, Ryan

AU - van Vollenhoven, Ronald F

PY - 2016

Y1 - 2016

N2 - INTRODUCTION: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib monotherapy was previously shown to inhibit structural damage, reduce clinical signs and symptoms of RA, and improve physical functioning over 24 months in methotrexate (MTX)-naive adult patients with RA. In this post hoc analysis, we compared efficacy and safety of tofacitinib in patients with early (disease duration <1 year) versus established (≥1 year) RA.METHODS: MTX-naive patients ≥18 years with active RA received tofacitinib monotherapy (5 or 10 mg two times a day, or MTX monotherapy, in a 24-month Phase 3 trial.RESULTS: Of 956 patients (tofacitinib 5 mg two times a day, n=373; tofacitinib 10 mg two times a day, n=397; MTX, n=186), 54% had early RA. Baseline disease activity and functional disability were similar in both groups; radiographic damage was greater in patients with established RA. At month 24, clinical response rates were significantly greater in patients with early versus established RA in the tofacitinib 5 mg two times a day group. Both tofacitinib doses had greater effects on clinical, functional and radiographic improvements at 1 and 2 years compared with MTX, independent of disease duration. No new safety signals were observed.CONCLUSIONS: Treatment response was generally similar in early and established RA; significantly greater improvements were observed at month 24 with tofacitinib 5 mg two times a day in early versus established RA. Tofacitinib 5 and 10 mg two times a day demonstrated greater efficacy versus MTX irrespective of disease duration. No difference in safety profiles was observed between patients with early or established RA.TRIAL REGISTRATION NUMBER: NCT01039688; Results.

AB - INTRODUCTION: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib monotherapy was previously shown to inhibit structural damage, reduce clinical signs and symptoms of RA, and improve physical functioning over 24 months in methotrexate (MTX)-naive adult patients with RA. In this post hoc analysis, we compared efficacy and safety of tofacitinib in patients with early (disease duration <1 year) versus established (≥1 year) RA.METHODS: MTX-naive patients ≥18 years with active RA received tofacitinib monotherapy (5 or 10 mg two times a day, or MTX monotherapy, in a 24-month Phase 3 trial.RESULTS: Of 956 patients (tofacitinib 5 mg two times a day, n=373; tofacitinib 10 mg two times a day, n=397; MTX, n=186), 54% had early RA. Baseline disease activity and functional disability were similar in both groups; radiographic damage was greater in patients with established RA. At month 24, clinical response rates were significantly greater in patients with early versus established RA in the tofacitinib 5 mg two times a day group. Both tofacitinib doses had greater effects on clinical, functional and radiographic improvements at 1 and 2 years compared with MTX, independent of disease duration. No new safety signals were observed.CONCLUSIONS: Treatment response was generally similar in early and established RA; significantly greater improvements were observed at month 24 with tofacitinib 5 mg two times a day in early versus established RA. Tofacitinib 5 and 10 mg two times a day demonstrated greater efficacy versus MTX irrespective of disease duration. No difference in safety profiles was observed between patients with early or established RA.TRIAL REGISTRATION NUMBER: NCT01039688; Results.

KW - Journal Article

U2 - 10.1136/rmdopen-2016-000262

DO - 10.1136/rmdopen-2016-000262

M3 - Article

VL - 2

SP - e000262

JO - RMD Open

JF - RMD Open

SN - 2056-5933

IS - 2

ER -