Pfizer reports positive top-line results from OPAL Beyond trial of Xeljanz in patients with PsA

8th June 2016 (Last Updated June 8th, 2016 18:30)

US drugmaker Pfizer has reported positive results from Oral Psoriatic Arthritis trial (OPAL) Beyond of Xeljanz (tofacitinib citrate) in treating active psoriatic arthritis (PsA).

US drugmaker Pfizer has reported positive results from Oral Psoriatic Arthritis trial (OPAL) Beyond of Xeljanz (tofacitinib citrate) in treating active psoriatic arthritis (PsA).

OPAL Beyond is a Phase III, randomised, double-blind, placebo-controlled trial conducted on a duration of six months to evaluate the safety and efficacy of tofacitinib administered in two dosages, 5mg and 10mg twice daily to PsA afflicted patients who previously had an inadequate response to at least one tumour necrosis factor inhibitor (TNFi).

The trial reported an overall safety across the broader rheumatology clinical development programme for tofacitinib.

PsA is a chronic inflammatory multisystem disease that causes symptoms such as joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis, and irreversible joint damage.

"There is a significant need for additional PsA treatment options as many people living with the condition do not respond well to available therapies."

Pfizer global innovative pharmaceuticals business inflammation and immunology category development lead Michael Corbo said: "There is a significant need for additional PsA treatment options as many people living with the condition do not respond well to available therapies.

"The positive results of both Phase III PsA studies, OPAL Broaden in DMARD-IR patients and OPAL Beyond in TNFi-IR patients demonstrate that tofacitinib, if approved, may have the potential to be an important treatment option to help address unmet needs for patients with PsA."

Xeljanz is a prescription medicine inhibiting the intracellular, nonreceptor tyrosine kinase, Janus kinase (JAK) and is taken by the patient orally and once per day.

The drug is approved to be used in more than 45 countries to treat moderate to severe rheumatoid arthritis (RA), following the failure of one or more disease-modifying antirheumatic drugs (DMARDs).