AbbVie’s ABBV-066 (risankizumab) for moderate-to-severe plaque psoriasis will likely face market hurdles despite highly expected regulatory approvals. Plaque psoriasis is the most common form of psoriasis and appears as patches of thick, red, scaly skin.

Although the drug has potential as a best-in-class treatment, as financial analysts widely predict, caveats remain with pricing and geographical uptake. AbbVie has not disclosed pricing plans for risankizumab. Risankizumab’s uptake may also be impeded if it does not have an effect on plaque psoriasis comorbidities such as psoriatic arthritis.

Regulatory approvals are anticipated based on positive Phase III safety and efficacy data. A PASI100 at week 52 secondary endpoint in two of the Phase III trials affirms approval outlook more than the primary endpoint of PASI90 at week 16 in all four trials, experts said. Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. The number attached to the score is the desired reduction in psoriasis attributes.

Risankizumab has a Prescription Drug User Fee Act (PDUFA) date of 25 April 2019, by which point the US FDA must make a decision on approval. The company announced in May it submitted a Marketing Authorisation Application to the EMA for approval.

Analysts predict risankizumab to be the best in class for psoriasis due to significant trial results for PASI90 compared to Johnson & Johnson’s Tremfya (guselkumab), which was FDA-approved in July 2017 and EMA-approved in November 2017 for moderate-to-severe plaque psoriasis.

Analysts predict peak sales for risankizumab to be $2.3bn worldwide. AbbVie has a market cap of $137bn.

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AbbVie did not respond to a request for comment.

Strong data potentially hampered by market dynamics

Four randomised, double-blind, placebo-controlled Phase III trials were conducted for risankizumab, with all having statistically significant results. They were the 500-patient ultIMMa-1 (NCT02684370) versus J&J’s Stelara (ustekinumab), the 500-patient ultIMMa-2 (NCT02684357) also versus Stelara, the 507-patient IMMhance (NCT02672852) with no active comparator and the 605-patient IMMvent (NCT02694523) versus AbbVie’s Humira (adalimumab).

Stelara was FDA-approved in September 2009 and EMA-approved in January 2009 for plaque psoriasis. Humira was FDA-approved in January 2008 and EMA-approved in December 2007 for moderate-to-severe plaque psoriasis.

Risankizumab demonstrated superiority to Stelara and placebo in both ultIMMa-1 and ultIMMa-2, which highlights that risankizumab may potentially be favoured among clinicians, said Dr Rolland Gyulai, chair, Department of Dermatology, Venereology and Dermatooncology, University of Pécs, Hungary, and Dr Alexander Egeberg, dermatologist, Department of Dermatology and Allergy, Copenhagen University Hospital, Denmark, speaking on the sidelines of the recent European Academy of Dermatology and Venereology (EADV) conference in Paris.

In addition, risankizumab’s dosing regimen of an injection every 12 weeks gives it preference over Tremfya’s injectable dosing regimen of every eight weeks, said Dr Jashin Wu, director of dermatology research, Kaiser Permanente Los Angeles Medical Center, California, and Dr Tiago Torres, dermatologist, University of Porto, Portugal.

However, although risankizumab’s efficacy profile is much stronger than current treatment options, uptake will differ by country, said Gyulai. Pricing may be an issue for adoption, said Gyulai, Egeberg, Wu and Torres. Pricing will also differ from country to country, affecting market uptake, said Torres and Gyulai.

In the US, clinicians would most likely be only allowed to prescribe risankizumab once patients have failed another two biologics such as Humira or Novartis’s Cosentyx (secukinumab) due to anticipated high costs, said Wu. The pricing will probably place it in the highest formulary tier in the US, said Wu, but did not comment on the exact price.

Risankizumab’s US cost may be similar to Tremfya’s, said Dr Randy Vogenberg, founding partner, National Institute of Collaborative Healthcare, Greenville, South Carolina. The average retail price of Tremfya in the US is $11,800 per 1 mL, according to public information.

In mid-October, the US government will release guidance on drug pricing that will be useful for patients, insurers, hospitals and physicians, said Vogenberg. That guidance can guide risankizumab’s pricing, he said.

EU uptake would be very dependent on price, said Gyulai. In Portugal, risankizumab’s price may be similar to that of Tremfya, of around €12,000 ($14,125), or even more annually, said Torres. When approved by the EMA, clinicians in Portugal would be able to prescribe risankizumab as a first-line treatment after methotrexate, as it shows more statistically significant and clinically significant data than interleukin 17 (IL-17) and tumour necrosis factor-α (TNF-alpha) inhibitors used to treat psoriasis, said Torres.

In Denmark, risankizumab’s uptake depends on the government’s policy of a national tender, whereby a country-wide decision is made for the recommended treatment for therapeutic indications, said Egeberg. At the moment, the preferred psoriasis therapies are IL-17 inhibitors, with the least expensive not necessarily having dominance, he said. The tender takes place every year, and with risankizumab’s strong data, there is a high chance that in the coming year, if approved, risankizumab will be on top, Egeberg said.

Besides the data for plaque psoriasis, market uptake will depend on the drug targeting psoriatic arthritis, a potential comorbidity, Gyulai, Torres and Egeberg said.

If risankizumab is approved, it may be used as an off-label treatment for psoriatic arthritis, said Torres, Egeberg and Gyulai. However, as Cosentyx is approved for both psoriasis and psoriatic arthritis, it may be a preferred treatment option for patients with moderate-to-severe plaque psoriasis, said Gyulai.

Strong approval prospects nonetheless

The strong data from the four trials supports approval, experts agreed. The ultIMMa-1 trial showed 75% of patients with a PASI90 at week 16 compared to 42% of patients on Stelara. The IMMvent results demonstrated that 72% of patients with risankizumab compared to 47% patients with Humira achieved PASI90 at week 16. At week 52, in the ultIMMa-1 study, 56% of risankizumab patients achieved PASI100 compared to 21% of Stelara patients, highlighting risankizumab’s clinical and statistical significance, in addition to superiority over Tremfya and Humira, enhancing approval prospects, said Gyulai, Torres, Wu and Egeberg.

Although the Phase III trials’ primary endpoint was PASI90 at week 16, the better clinical measure was the secondary outcome measure of PASI100 at week 52 for ultIMMa-1 and ultIMMa-2, said Wu and Egeberg. They explained the latter endpoint indicates complete clearance of plaque psoriasis. For IMMhance, PASI100 at week 52 was defined as other outcome measures and for IMMvent, PASI100 at week 44 was a secondary endpoint.

The four Phase III trials showed treatment-emergent adverse event profiles that were similar across treatment groups with no unexpected safety findings. This highlights risankizumab’s positive safety profile, supporting approval, said Wu, Gyulai, Egeberg and Torres.

The strong safety profile of risankizumab, an interleukin 23 (IL-23) inhibitor, is similar to that of Cosentyx, an IL-17 inhibitor, said Gyulai, Torres and Egeberg. Cosentyx was FDA-approved in February for moderate-to-severe plaque psoriasis. Unlike IL-23s and IL-17s, TNF-α inhibitors such as J& J’s Remicade (infliximab) do not have strong safety profiles, as they increase infection risks, said Torres and Gyulai.

by Arafa Salam, PhD, in London

Arafa Salam, PhD, is a reporter for Pharmaceutical Technology parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.