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21-02-2019 | Spondyloarthropathies | Feature | Article

Trials of JAK inhibitors in spondyloarthritis: A round-up

Findings from a number of randomized controlled trials have demonstrated that Janus kinase (JAK) inhibitors – including tofacitinib and filgotinib – may be a promising drug class for the treatment of spondyloarthritis, and tofacitinib is now approved for psoriatic arthritis (PsA) in the USA and Europe. To accompany our interview with Dafna Gladman on the role of JAK inhibitors in PsA therapy, here is a round-up of the completed and ongoing clinical trials investigating JAK inhibitors in patients with PsA and ankylosing spondylitis.

Tofacitinib (JAK1/3 inhibitor)

Findings from the seven published and ongoing clinical trials of tofacitinib for the treatment of PsA and ankylosing spondylitis are summarized in this article.

Filgotinib (selective JAK1 inhibitor)


EQUATOR: PsA

Phase II

Patient population: Moderate-to-severe PsA and an insufficient response or intolerance to at least one conventional DMARD

Treatment groups: Filgotinib 200 mg/day or placebo for 16 weeks

Status: Published

https://clinicaltrials.gov/ct2/show/NCT03101670

As reported at the 2018 ACR/ARHP Annual Meeting in Chicago, Illinois, USA, and published in The Lancet in October 2018, the EQUATOR trial investigated the efficacy and safety profiles of the selective JAK1 inhibitor filgotinib in PsA patients from seven European countries. A significantly higher proportion of patients treated with filgotinib compared with placebo achieved an ACR20 response at week 16 (80 vs 33%), and the investigators say that no new safety concerns were identified.

Related news story: Filgotinib shows promise in psoriatic arthritis treatment

TORTUGA: Ankylosing spondylitis

Phase II

Patient population: Ankylosing spondylitis and an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs (NSAIDs)

Treatment groups: Filgotinib 200 mg/day or placebo for 12 weeks

Status: Published

https://clinicaltrials.gov/ct2/show/NCT03117270

Also published in The Lancet in October 2018, the results of the TORTUGA trial suggest that ankylosing spondylitis patients who are treated with filgotinib may experience greater reductions in disease activity than those given placebo. The average reduction in ASDAS from baseline to week 12 was 1.47 points in the filgotinib group versus 0.57 points in the placebo group, a significant difference, and patients experienced improvements in disease activity after 1 week of treatment.

Related news story: Further investigation of filgotinib warranted in ankylosing spondylitis patients

Upadacitinib (selective JAK1 inhibitor)


SELECT-PsA 1

Phase III

Patient population: Moderate-to-severe PsA and an inadequate response to at least one nonbiologic DMARD

Treatment groups: Upadacitinib once daily, placebo, or adalimumab every other week (specific dosing information not currently available)

Status: Recruiting

https://clinicaltrials.gov/ct2/show/NCT03104400

The SELECT-PsA 1 trial will compare the efficacy, safety, and tolerability of two different doses of upadacitinib, placebo, and the active comparator adalimumab. Recruitment is currently underway, and the estimated completion date is November 2022.

SELECT-PsA 2

Phase III

Patient population: Moderate-to-severe PsA and an inadequate response to at least one biologic DMARD

Treatment groups: Upadacitinib once daily or placebo (specific dosing information not currently available)

Status: Recruiting

https://clinicaltrials.gov/ct2/show/NCT03104374

SELECT-PsA 2 is a placebo-controlled trial of two doses of upadacitinib for the treatment of PsA. Along with SELECT-PsA 1, the trial is currently recruiting participants and is expected to complete in February 2022.

SELECT Axis 1: Ankylosing spondylitis

Phase II/III

Patient population: Ankylosing spondylitis patients with an inadequate response to at least two NSAIDs

Treatment groups: Upadacitinib once daily or placebo (specific dosing information not currently available)

Status: Ongoing

https://clinicaltrials.gov/ct2/show/NCT03178487

SELECT Axis 1 is expected to complete in November 2020, and will investigate the efficacy and safety profiles of upadacitinib in ankylosing spondylitis patients.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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