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You are here: Home / Articles / Tofacitinib with Methotrexate Not Inferior to Adalimumab with Methotrexate

Tofacitinib with Methotrexate Not Inferior to Adalimumab with Methotrexate

July 13, 2017 • By Thomas R. Collins

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Highlights from the 2017 EULAR Congress

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MADRID—Tofacitinib (a JAK inhibitor) used with methotrexate (MTX) is not inferior to adalimumab (a TNF inhibitor) plus MTX in rheumatoid arthritis (RA) patients who’ve had an inadequate response to MTX alone, according to results of a Phase 3B/4 trial presented in a session at the Annual European Congress of Rheumatology (EULAR).

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The findings came in a one-year trial, called the ORAL Strategy, with three active treatment arms, meant to compare tofacitinib alone with tofacitinib plus MTX, tofacinitib alone with adalimumab plus MTX, and tofacitinib plus MTX with adalimumab plus MTX (see Table 1, below).1

Table 1: ORAL Strategy

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Enrollment: 1132
Study Start Date: August 2014
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tofacitinib 5 mg twice daily with methotrexate Drug: Tofacitinib with methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months
Methotrexate (previous stable dose 15–25 mg) every week, oral for 12 months
Placebo for adalimumab every other week, subcutaneous for 12 months
Experimental: Tofacitinib 5 mg twice daily monotherapy Drug: Tofacitinib without methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months
Placebo for methotrexate (previous stable dose) every week, oral for 12 months
Placebo for adalimumab every other week, subcutaneous for 12 months
Active Comparator: Adalimumab with methotrexate Biological: Adalimumab with methotrexate; Placebo for tofacitinib twice daily, oral for 12 months
Methotrexate (previous stable dose 15–25 mg) every week, oral for 12 months
Adalimumab 40 mg every other week, subcutaneous for 12 months

Source: ClinicalTrials.gov, NCT02187055

In the other comparisons, performed using an efficacy threshold derived from a meta-analysis of adalimumab trials, tofacitinib alone landed in a kind of statistical limbo when compared with adalimumab plus MTX: It wasn’t shown to be worse, nor was it shown to be superior. The same was found for tofacitinib alone compared with tofacitinib plus MTX.

The main point of the trial was to settle remaining questions from tofacitinib’s Phase 3 trial, which suggested that perhaps tofacitinib alone was better than tofacitinib with MTX—which was found not to be true in this trial—and that tofacitinib with MTX was better than adalimumab.

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The Trial

One thousand one hundred and forty-six patients were randomized: 384 were treated with 5 mg tofacitinib monotherapy orally twice a day, 5 mg tofacitinib twice a day plus MTX or adalimumab plus MTX.

There was no significant difference between the groups, with 46% of the tofacitinib plus MTX patients achieving an ACR50 response after six months, compared with 43.8% of adalimumab plus MTX patients and 38.3% of the tofacitinib-alone patients. In a subsequent analysis, tofacitinib plus MTX was not found to be superior to adalimumab plus MTX.

Pages: 1 2 3 | Single Page

Filed Under: DMARDs & Immunosuppressives, Drug Updates, Meeting Reports Tagged With: EULAR 2017

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