AbbVie celebrated a double victory on Thursday, after announcing the successful completion of two clinical trials. The Phase III INSPIRE study revealed that the drug Skyrizi (risankizumab) exceeded its primary and secondary endpoints in ulcerative colitis (UC). This breakthrough provides a much-needed advancement in the treatment of this condition.
Rinvoq (upadacitinib) has just made a huge breakthrough in the treatment of systemic lupus erythematosus (SLE), as the results of its Phase II SLEek trial have shown its therapeutic potential. This is a major step forward in the search for a reliable treatment for SLE sufferers, giving hope to those who have been struggling with the debilitating symptoms of the condition.
The INSPIRE trial, which was randomized, double-blinded, and placebo-controlled, enrolled a total of 1,554 patients with moderately to severely active UC. Participants in the trial received 1,200-mg intravenous doses of Skyrizi every four weeks for 12 weeks after which the efficacy of the medication was measured in terms of clinical remission, as indicated by the Adapted Mayo Score. The results of this trial are eagerly anticipated to provide further insight into the effectiveness of Skyrizi in treating UC.
Skyrizi delivered a remarkable outcome, with a 20.3% clinical remission rate compared to an insignificant 6.2% in the placebo group, according to AbbVie. This shows that Skyrizi is a powerful and effective treatment for those struggling with their conditions.
The study found that Skyrizi treatment showed significant improvements in secondary efficacy endpoints such as clinical response, endoscopic improvement, and histologic-endoscopic mucosal improvement, when compared to placebo. In other words, Skyrizi proved to be an effective treatment for the condition.
The groundbreaking study conducted by INSPIRE has revealed the potential of risankizumab to treat various forms of inflammatory bowel diseases. According to Dr. Edouard Louis, one of the study’s investigators, risankizumab could offer a promising new option for those living with these diseases.
Skyrizi has come up trumps once again, with a safety profile that is consistent with its previous studies across other indications. Adverse events were experienced by a mere 2.3% of patients using Skyrizi, compared to a much higher 10.2% in the placebo group. All in all, this medication has proven to be a safe and effective treatment option for many.
Tragically, the Skyrizi group experienced a fatality due to complications from COVID-19.
This month, AbbVie unveiled Phase IIIb results for Skyrizi, a promising new treatment for plaque psoriasis, which showed that patients with moderate to severe disease who had previously failed to respond to IL-17A inhibitors secukinumab or ixekizumab experienced significant symptom improvements. The results mark an important milestone in the fight against psoriasis, offering hope for those who have not found relief with existing treatments.
Rinvoq Moves to Phase III
On Thursday, AbbVie announced some exciting news: Rinvoq, a once-daily medication given as a monotherapy or in combination with a BTK inhibitor, had met its primary endpoint in the Phase II SLEek study. This development will bring the program to Phase III and could potentially revolutionize the treatment of systemic lupus erythematosus.
Rinvoq, a potential treatment for those with moderately to severely active SLE, was tested in 341 patients in the SLEek trial. By evaluating its effects on disease activity and steroid dose without worsening overall condition or triggering new organ system involvement, researchers were able to measure the efficacy of the drug in treating SLE.
Rinvoq’s 30-mg dose was found to be safe in a recent study, with no new safety signals arising. The safety profile was consistent with previous studies, showing the drug is just as safe as before.
AbbVie is eagerly anticipating the opportunity to showcase their data and analyses at an upcoming medical congress, eager to demonstrate their findings to the medical community.
AbbVie’s clinical successes are paving the way for a bright future, despite the impending drop in sales of the blockbuster drug Humira (adalimumab) due to biosimilar competition. With these impressive clinical achievements, AbbVie is well-positioned to weather the storm and continue its success.
At the 41st J.P. Morgan Healthcare Conference in January, Rick Gonzalez, CEO, made a bold prediction that AbbVie’s two medicines, projected to bring in more than $17.5 billion by 2025, and more than $21 billion in expected sales by 2027, would exceed even Humira’s peak revenue.