Psoriatic arthritis is an inflammatory disorder, which is characterized by joint inflammation. This systemic inflammatory disease, once considered harmless, has been shown to cause other health dysfunctions such as cardiovascular diseases. Around 0.25% of the world population suffers from this disease. The prevalence of the disease is approximately 40% in patients with psoriasis.
The current treatment for psoriatic arthritis includes non-steroidal anti-inflammatory drugs, immunosuppressive drugs, or joint replacement surgeries. On November 5th, swiss biopharma giant Novartis announced encouraging results from its Phase IIIb trial for psoriatic arthritis with their blockbuster drug Cosentyx (1,2).
In a first of its kind Phase IIIb clinical trial that enrolled 414 participants, a time-dependent response to Cosentyx in patients with active psoriatic arthritis was analyzed for 12 weeks using Power Doppler ultrasonography. This imaging technique can be used to detect and monitor psoriatic arthritis. Standardized ultrasound synovitis score (GLOESS), which was used as a primary endpoint, showed that Cosentyx significantly improved synovitis compared to the placebo group.
Cosentyx also improved secondary endpoints, and the safety profile of the drug was consistent with previous clinical trials. This study will continue for 24 weeks to further test the safety and efficacy of the drug. The biopharma intends to present detailed results at the ongoing American College of Rheumatology (ACR) All-Virtual Annual Meeting.
Dr. Maria A. D’Agostino, Professor of Rheumatology at the Catholic University of Rome, said, “Psoriatic arthritis can have a significant impact on a patient’s joints. Joint lining inflammation, also known as synovitis, if left untreated, can cause pain to worsen, joint damage, and may decrease physical function. These data are highly encouraging, showing Cosentyx can significantly reduce synovitis at Week 12 versus placebo with results seen as early as Week 1, and that ultrasound is a sensitive and objective tool to monitor joint inflammation in PsA patients.”
Dr. Catherine Bakewell, an investigator in the ULTIMATE study, commented on the diagnostic approach of the clinical trial, “As a strong believer in the diagnostic and treatment monitoring benefits of ultrasound, this first large randomized, double-blind placebo-controlled clinical trial in PsA with an ultrasonographic primary endpoint is incredibly exciting. The ability to use a sensitive imaging technique to assess synovitis and enthesitis in PsA represents a breakthrough in how we conceptualize treatment goals. In addition to other measures, PDUS helps to provide earlier insight into treatment response, and that patients are more effectively treated across multiple domains of this heterogeneous psoriatic disease spectrum.” (3,4)
Cosentyx, Novartis’s superhit drug, is an inhibitor of interleukin-17A (IL-17A). IL-17 is a pro-inflammatory cytokine that plays an important role in the host immune response. Hyperactivation of the immune system leading to systemic inflammatory diseases can lead to high levels of IL-17. Since its first approval in 2015, Cosentyx has bagged multiple acceptances, the latest being approval from the European Union to treat pediatric psoriasis. More than 40,000 people have received Cosentyx for various inflammatory disorders (3,5).
Cosentyx faces stiff competition from Amgen’s drug Otezla, one of the few approved oral pills, as well as Bristol Myer Squibb’s Deucravacitinib, which recently announced encouraging Phase III trial data. Currently, Amgen’s Otezla has a monopoly over the market, and with the COVID-19 pandemic, orally available pills are being preferred over drugs that have to be injected.
Amgen paid $13.4 billion to acquire the drug, and it paid off immediately, with Otezla racking up around $600 million in one quarter during the pandemic. But that may well change shortly as Bristol Myer Squibb’s Deucravacitinib showed that their drug is better than Otezla. With Novartis entering the competition, it will be a three-way battle between these pharmaceutical giants.
By T. Chakraborty, Ph.D.
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