PracticalDermatology

AbbVie Buys Rights to Boehringer Psoriasis Drug for $595 Million

AbbVie Inc. and Boehringer Ingelheim are collaborating to develop and commercialize BI 655066, an anti-IL-23 monoclonal biologic antibody in Phase 3 development for psoriasis. AbbVie has acquired the marketing rights for the experimental drug for an initial upfront payment of $595 million.

According to the companies, anti-IL-23 antibody demonstrated greater efficacy over ustekinumab in Phase 2 clinical studies with a potential for quarterly dosing.

In addition, AbbVie has gained rights to an anti-CD-40 antibody, BI 655064, currently in Phase 1 development. Boehringer Ingelheim will be responsible for further development of BI 655064, while AbbVie may elect to advance the program after completion of certain undisclosed clinical achievements.

In the initial period, both companies will share responsibility for future development of BI 655066. AbbVie will be responsible for commercialization of BI 655066, while Boehringer Ingelheim will retain an option to co-promote the compound in asthma. The companies plan to establish a joint Steering Committee for the development as well as the initial commercialization phase.

Ixekizumab Demonstrates High Levels of Skin Clearance

Eli Lilly and Company shared Phase 3 clinical trial data showing that patients with moderate-to-severe plaque psoriasis who did not respond to treatment with etanercept achieved significant improvement in their psoriasis plaques when treated with ixekizumab. Detailed results of the UNCOVER-2 study were presented during the 2016 American Academy of Dermatology (AAD) Annual Meeting in Washington, DC

In UNCOVER-2, 64 percent (229/358) of patients treated with bi-weekly etanercept did not respond to treatment at 12 weeks. These nonresponders were treated with placebo at 12 weeks, then received ixekizumab every four weeks from Weeks 16 through 60. This study’s co-primary efficacy endpoints at 12 weeks of ixekizumab therapy were PASI 75 and sPGA 0 or 1.

Among those patients who did not respond to etanercept, the following was observed at 24 weeks of the study, 12 weeks following treatment with ixekizumab:

• 83.5 percent of patients achieved PASI 75;
• 57 percent of patients achieved PASI 90;
• 22 percent of patients achieved complete resolution of psoriasis plaques (PASI 100).

At 48 weeks following treatment with ixekizumab, the following was also observed at week 60 of the study among those who did not respond to etanercept:

• 82.5 percent of patients achieved PASI 75
• 68.5 percent of patients achieved PASI 90;
• 43.5 percent of patients achieved complete resolution of psoriasis plaques (PASI 100).

Additionally, 73 percent of those patients who did not respond to etanercept achieved sPGA 0 or 1 12 weeks after starting treatment with ixekizumab.

The majority of treatment-emergent adverse events were mild or moderate. The safety profile after receiving ixekizumab treatment was comparable among patients who initially received etanercept and patients who initially received placebo in this clinical trial.

Cosentyx Demonstrated Sustained Superiority in Skin Clearance

Novartis presented late-breaking data from the head-to-head CLEAR study, showing that Cosentyx (secukinumab) was superior in achieving a key secondary efficacy endpoint of near clear skin on the Psoriasis Area Severity Index (PASI 90) in significantly more moderate-to-severe psoriasis patients compared to ustekinumab at Week 52. These findings were presented for the first time at the 2016 AAD Meeting

Cosentyx, a fully human interleukin-17A (IL-17A) antagonist, is approved to treat adult patients with moderate to severe plaque psoriasis, with almost 15,000 U.S. patients prescribed to date. Cosentyx also was recently FDA-approved for the treatment of psoriatic arthritis and ankylosing spondylitis.

Meeting the primary and all secondary endpoints at both Week 16 (PASI 90 response for the Cosentyx treatment group was 80.1 percent vs 59 percent for the Stelara treatment group; P<0.0001) and Week 52, Cosentyx demonstrated it remained superior to Stelara in achieving PASI 90 (76.2 percent vs. 60.6 percent; P<0.0001) at Week 52. As previously presented, this study also demonstrated 50.0% of Cosentyx patients achieved PASI 75 at Week 4 compared to 20.6 percent of Stelara patients (P<0.0001).

In an exploratory analysis, a higher percentage of Cosentyx patients achieved completely clear skin (PASI 100) compared to Stelara patients at Week 52 (45.9 percent vs. 35.8 percent; P=0.0103.) Cosentyx also showed significantly greater Dermatology Life Quality Index (DLQI) 0/1 responses versus Stelara (71.6 percent vs. 59.2 percent; P=0.0008).

The safety profile of Cosentyx was consistent with previously reported Phase III trials and similar to Stelara. 

Steroids, Steroid/Vitamin D Combo Best Bets for Scalp Psoriasis

Steroids and the two-compound combination of a steroid plus vitamin D are the most effective treatments for scalp psoriasis, according to a new Cochrane review.

Statistically, the combination product was more effective than the steroid alone, but clinically the benefit was questionable.

The new review included 59 randomized controlled trials with a total of 11,561 participants. Thirty studies were either conducted or sponsored by the manufacturer of the study medication.  Most findings were limited to short-term treatments, since most studies were conducted for less than six months. Only one trial investigated long-term therapy (12 months). Most studies did not measure improvement in quality of life. The authors graded the quality of evidence to three major comparisons: steroid versus vitamin D, two-compound combination of steroid and vitamin D versus steroid monotherapy and versus vitamin D. There was not enough evidence to assess the efficacy and safety of other topical treatments, such as salicylic acid, tar or dithranol.

Going forward, long-term studies as well as those that assess quality of life are warranted, the review authors note. Other questions that remain include “Is there truly no difference in terms of effectiveness or safety between topical corticosteroids of different strength? Does the vehicle preparation have any influence on how the active agent works? Which topical treatment leads to disease control over a long time span without risking patient’s safety?” n