AbbVie may see its star Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib) enter its eighth indication following the positive results of two late-stage trials in non-segmental vitiligo (NSV).
In the Viti-Up studies (NCT06118411), the drug met its primary endpoint, triggering a 50% reduction in total vitiligo area scoring index (T-VASI 50) in 19.4% and 21.5% of patients in study one and two, respectively, compared with baseline.
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Treatment with Rinvoq also offered improvements to facial vitiligo area scoring index (F-VASI 75) values, with 25.2% and 23.4% of patients achieving 75% vitiligo facial clearance at week 48.
Meanwhile, Rinvoq met its secondary endpoint, demonstrating a 50% clearance of facial vitiligo in 48.1% and 43.4% of patients receiving Rinvoq, respectively, across the two studies.
From a safety perspective, Rinvoq performed similarly in NSV to how it has in its other approved indications, with the most common treatment-emergent adverse events (TEAEs) being nasopharyngitis, upper respiratory tract infections and acne.
There were serious adverse events (SAEs) observed in 3.9% and 4% of patients in the Rinvoq arm, but none of these were major cardiovascular or venous thromboembolism events.
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By GlobalDataAccording to Thierry Passeron, professor and chair of the department of dermatology at Université Côte d’Azur, these results indicate that “targeting the underlying inflammation” associated with NSV could offer patients a treatment option that “helps achieve visible results”.
The promising results of the Viti-Up studies follow Rinvoq’s double Phase III success in alopecia areata, which prompted AbbVie to file for the drug’s approval with the US Food and Drug Administration (FDA).
Both of these outcomes will be a win for AbbVie, which is now counting on its immunology portfolio – particularly Skyrizi (risankizumab) and Rinvoq – to balance the sales loss of its bestseller Humira, which recently fell off the patent cliff.
To prolong Rinvoq’s value, AbbVie recently extended the drug’s market exclusivity by four years to 2037. The US-based pharma achieved this by striking deals with generic manufacturers, who were looking to commercialise copycat drugs by the drug’s patent expiry date of 2033.
Cracking the vitiligo market
If Rivoq were to obtain approval in vitiligo, it would become one of two targeted drugs available on the market, as Incyte Corporation’s topical JAK inhibitor, Opzelura (ruxolitinib), got the FDA go-ahead in 2022.
Analysts at GlobalData predict that Opzelura will take the market lead over Rinvoq if it were to obtain approval in the indication. AbbVie’s drug is forecast to bring in $562m globally in NSV in 2031.
Meanwhile, analysts at GlobalData estimate that Opzelura will make global sales of $590m in the NSV indication alone by 2031. This likely stems from Opzelura’s topical administration, which boosts patient convenience.
GlobalData is the parent company of Clinical Trials Arena.
However, Rinvoq is not the only oral JAK inhibitor looking for a slice of the NSV market, as Pfizer’s Litfulo (ritlecitinib) is currently being explored in the Phase III Tranquillo (NCT05583526) study. This trial is set for completion in March 2026, according to ClinicalTrials.gov.
Outside of NSV, Rinvoq’s sales are expected to hit mega blockbuster status by 2027, with the drug’s sales peaking in 2031 at $15bn.
