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06-04-2018 | Spondyloarthropathies | Feature | Article

At a glance: Trials of tofacitinib in spondyloarthritis

Following the approval of tofacitinib as the first Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis by the US FDA in 2012, the drug has also demonstrated efficacy in patients with spondyloarthritis. The majority of these trials were conducted in patients with psoriatic arthritis (PsA), and in December 2017 the indication of tofacitinib was expanded to include PsA in the USA.

Here is a quick-reference guide to the published and ongoing clinical trials of tofacitinib for the treatment of spondyloarthritis, all of which are sponsored by the drug’s manufacturer Pfizer.

OPAL BROADEN: PsA

Phase III

Patient population: Active PsA and an inadequate response to conventional DMARDs

Treatment groups: Tofacitinib 5 mg or 10 mg twice daily, adalimumab, or placebo

Status: Published

https://clinicaltrials.gov/show/NCT01877668

The findings from OPAL BROADEN, published in The New England Journal of Medicine in October 2017, showed that patients treated with tofacitinib 5 mg or 10 mg were significantly more likely to achieve at least a 20% improvement in ACR criteria (ACR20) after 3 months of treatment than placebo-treated patients, with corresponding rates of 50% and 61% versus 33%. The ACR20 response rate was 52% in the adalimumab group.

Patients in the tofacitinib 5 mg and 10 mg groups also experienced significantly greater reductions in mean Health Assessment Questionnaire–Disability Index (HAQ–DI) scores than those in the placebo group (0.35 and 0.40 versus 0.18 points).

Related news story: Towards new treatment options for psoriatic arthritis

OPAL BEYOND: PsA

Phase III

Patient population: Active PsA and an inadequate response to TNF inhibitors

Treatment groups: Tofacitinib 5 mg or 10 mg twice daily, or placebo

Status: Published

https://clinicaltrials.gov/show/NCT01882439

The OPAL BEYOND results were also published in The New England Journal of Medicine in October 2017. The investigators demonstrated that ACR20 response rates at the 3-month follow-up were significantly higher among patients treated with tofacitinib 5 mg or 10 mg versus placebo, at 50% and 47% versus 24%, respectively. Similarly to the OPAL BROADEN results, tofacitinib-treated patients had significantly greater improvements in HAQ–DI scores, with average reductions of 0.39 and 0.35 points versus 0.14 points for the placebo group.

Related news story: Phase III results support tofacitinib for psoriatic arthritis

NCT01519089: PsA

Phase III

Patient population: Japanese patients with moderate-to-severe plaque psoriasis and/or psoriatic arthritis

Treatment groups: Tofacitinib 5 mg or 10 mg twice daily

Status: Published

https://clinicaltrials.gov/ct2/show/NCT01519089

The results of this trial, published in The Journal of Dermatology in February 2016, demonstrated that 62.8% of patients receiving tofacitinib 5 mg and 72.7% of those given the 10 mg dose achieved at least a 75% reduction in Psoriasis Area and Severity Index (PASI75) score from baseline. All PsA patients achieved an ACR20 response at week 16.

OPAL BALANCE: PsA

Phase III

Patient population: Patients with active PsA who previously participated in a randomized trial of tofacitinib

Treatment groups: Tofacitinib 5 mg or 10 mg twice daily, methotrexate, or placebo

Status: Ongoing

https://clinicaltrials.gov/ct2/show/NCT01976364

This long-term open-label extension study will evaluate the safety, tolerability, and efficacy of tofacitinib for up to 36 months. A sub-study will assess the safety and efficacy profile of tofacitinib 5 mg given after methotrexate withdrawal compared with that of the same dose of tofacitinib given in combination with methotrexate.

NCT01786668: Ankylosing spondylitis

Phase II

Patient population: Active ankylosing spondylitis and no prior biologic DMARD treatment

Treatment groups: Tofacitinib 2 mg, 5 mg, or 10 mg twice daily, or placebo

Status: Published

https://clinicaltrials.gov/ct2/show/NCT01786668

As reported in the Annals of the Rheumatic Diseases in January 2017, the proportion of patients achieving at least a 20% improvement in Assessment of SpondyloArthritis International Society (ASAS) criteria at week 12 was 51.9%, 80.8%, and 55.8% in the tofacitinib 2 mg, 5 mg, and 10 mg groups, respectively. By comparison, 41.2% of placebo-treated patients achieved an ASAS20 response. Although all active treatment groups had numerically higher ASAS20 response rates than the placebo group, the difference only reached statistical significance with tofacitinib 5 mg.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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