AbbVie’s star Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib), has met its primary endpoints in a second Phase III study in alopecia areata.
In Study 1 of the UP-AA clinical programme (NCT06012240), the inflammation blocker triggered a statistically significant increase in scalp hair coverage, with 45.2% and 55% of patients reaching 80% scalp hair coverage after 24 weeks of treatment with 15mg and 30mg daily doses, respectively. This was measured through the Severity of Alopecia Tool (SALT) scores.
In addition, 45.8% of patients given the higher dose of Rinvoq reached scalp coverage of more than 90% while this phenomenon was noted in 35.2% of patients given 15mg of Rinvoq daily.
According to a 21 August statement, some patients obtained full scalp hair coverage during the trial, while others experienced improvements in eyebrow and eyelash growth. AbbVie has yet to disclose specific details on these findings.
The safety profile of the drug was also generally manageable for a JAK inhibitor, with 1.1% and 1.5% of patients given 15mg and 30mg of Rinvoq, respectively, discontinuing use due to treatment-associated adverse events (TEAEs).
This comes several weeks after AbbVie announced that in Study 2 of the UP-AA programme, 44.6% and 54.3% of patients with severe alopecia areata treated with Rinvoq 15mg and 30mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by SALT scores.
Moving forward, AbbVie will submit the results of both studies to regulatory bodies for Rinvoq’s approval in this indication. The drug has already been authorised for use in a range of immune-related inflammatory diseases in adults, including rheumatoid arthritis, ulcerative colitis (UC) and Crohn’s disease.
According to GlobalData’s estimates, the drug could gain approval by 2029 for alopecia areata. GlobalData is the parent company of Clinical Trials Arena.
If Rinvoq were to receive approval from the US Food and Drug Administration (FDA), it would be one of a chain of JAK inhibitors that have gained approval in the indication, joining Eli Lilly and Incyte’s Olumiant (baricitinib), Pfizer’s Litfulo (ritlecitinib) and Sun Pharma’s Leqselvi (deuruxolitinib) on the market.
However, Rinvoq could be set to dominate the market if approved, as it exhibits a strong efficacy profile compared with its main competitor, Olumiant, as the latter only triggered 80% scalp hair coverage in 32-35% of participants given the highest dose in the Phase III BRAVE-AA1 and BRAVE-AA2 trials (NCT03570749, NCT03899259).
Though this drug class is effective in a range of inflammatory diseases, it has been controversial with regulators due to its association with serious adverse events – including cancer, heart attack, stroke and serious infections.
This has led the FDA to place restrictions on their use, with the regulator requiring pharma companies to display a “black box warning” on the packaging of their JAK inhibitor, which discloses the major risks associated with their use.
The European Medicines Agency (EMA) later echoed this sentiment, advising that JAK inhibitors should only be used in older patients, individuals at risk of cardiovascular events, smokers and those at increased risk of cancer if there is no other suitable treatment option available.
However, these restrictions have not stopped the growth of Rinvoq in other inflammatory disease markets, as the drug made $5.9bn for AbbVie in 2024 – a 47.5% boost from the $4bn it pulled in in 2023.
It is a similar story for Litfulo and Leqselvi, with analysts at GlobalData predicting that both drugs’ sales will continue to rise up to 2031, reaching more modest highs of $540m and $397m, respectively, during that year.
The same cannot be said for Olumiant, which peaked at sales of $1.1bn in 2021, experiencing a $284m decline to $831m in 2022 before plateauing at $957m in 2024. Moving forward, analysts at GlobalData forecast that the drug will experience a slight dip in sales, bringing in $817m for Lilly and Incyte by 2031.
