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AbbVie builds case for arthritis blockbuster-in-waiting upadacitinib

Patients with RA reported an improvement in mobility pain on the JAK1 inhibitor

AbbVieAbbVie’s run of positive results for upadacitinib in rheumatoid arthritis continues with new data at EULAR on patients’ experience with the drug.

The orally-administered JAK1 inhibitor has already been shown in phase III trials to be more effective than AbbVie’s injectable TNF blocker Humira (adalimumab) when it comes to clinical responses gauged by doctors. Now, data gleaned from three pivotal trials show that patients also report significant improvement in pain, physical functioning, and morning joint stiffness, as well as fatigue and work instability.

"These results show upadacitinib's potential to address the challenges rheumatoid arthritis patients face when performing everyday activities,” commented AbbVie’s head of immunology development Marek Honczarenko.

AbbVie says patient-reported outcome data are “an important component of understanding how rheumatoid arthritis patients perceive the physical, psychological and social impact of their disease”.

Outperforming both placebo and Humira - the top-selling drug in the world with sales of $18bn last year - has analysts excited that an oral drug could rival injectable biologics in RA, and Jefferies has predicted that sales could eventually reach $3.5bn.

They think the drug could overtake Pfizer’s Xeljanz (tofacitinib), the first JAK inhibitor to reach the market for RA with sales of $1.35bn last year, but say this could be an under-estimate given that a third JAK inhibitor - Eli Lilly and Incyre’s Olumiant (baricitinib) - has been dogged by regulatory problems.

Olumiant was finally approved by the FDA for RA a couple of weeks ago, but has been saddled with a black box warning about the risk of thrombotic side effects such as pulmonary embolism (PE) or deep vein thrombosis (DVT) and an uncompetitive dose.

The US regulator approved only the lower of two tested in trials, and only the higher dose bested Humira in trials. Lilly has said it will continue trying to build evidence for the safety of the higher dose and in the interim has priced its drug low - undercutting Humira by around 60% - to try to compensate.

Thrombotic risks have also been a point of scrutiny in AbbVie’s development programme for upadacitinib, but the company insists that while the drug does cause a decrease in platelets - cells in the blood involved in clotting - the effect is transient and resolves over time.

AbbVie has positive results from four of five pivotal trials of upadacitinib in RA and, according to the company’s chief executive Richard Gonzalez, “each study has reinforced our view that upadacitinib is truly a best-in-class asset.” The results of the fifth trial are due in the coming months and – barring any unforeseen problems - should be followed by regulatory filings in the second half of the year.

Meanwhile, following the same path as Xeljanz, upadacitinib is also being tested in a string of other indications, including psoriatic arthritis, Crohn’s disease, ulcerative colitis and atopic dermatitis.

13th June 2018

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