New AbbVie RA Drug Approved by the FDA

New AbbVie RA Drug Approved by the FDA

Humira, generically known as adalimumab, has been the gold standard for treatment of RA particularly in patients that have not responded to other forms of treatment. In 2016 4 million prescriptions for Adalimumab were given out. This is a biologic drug and like other TNF inhibitors, it is an immunosuppressive medication.

In August the manufacturers of adalimumab, AbbVie, were awarded FDA approval for a new RA DMARD (disease-modifying antirheumatic drug). The drug, Rinvoq (upadacitinib), is a Janus kinase (JAK) inhibitor. AbbVie used five distinct clinical outcome measurements to compare its two drugs. Rinvoq scored better than Humira on all five measures of efficacy.

Three of these measured outcomes were established on the American College of Rheumatology’s measurements of improvement in the systems of rheumatoid arthritis — ACR20, ACR50, and ACR70, which revealed a 20%, 50%, and 70% improvement, respectively. Seventy-one percent of patients taking Rinvoq achieved an ACR20 response, compared with 63% of patients taking Humira. ACR50 response rates showed Rinvoq to be superior, with 45% of patients achieving the level of improvement versus 29% for patients receiving Humira. Nearly double the patients taking Rinvoq achieved an ACR70 response compared with those on Humira (25% compared to 13%).

Furthermore, a significantly higher percentage of patients taking Rinvoq achieved clinical remission (29%) than patients receiving Humira (18%). Low disease activity was observed in 45% of patients taking Rinvoq compared to 29% of patients taking Humira.

JAK inhibitors are therefore used effectively to ease joint pain and swelling. This class of drugs works by turning down an over active immune system in order to prevent damage to a patient’s joints. Previous to this approval there were two JAK inhibitors already on the market baricitinib (Olumiant by Eli Lilly) and tofacitinib (Xeljanz by Pfizer). Adalimumab is set to compete with these two drugs.

How JAK Inhibitors Work

Patients with RA have an overproduction of proteins known as cytokines. These proteins have a significant role in inflammation and inflammatory processes. Certain cytokines when binding to their cognate receptor result in cell signalling that further increases the production of cytokines. JAK inhibitors work by blocking this signalling pathway limiting further production of cytokines. This helps to calm the immune system and decrease RA symptoms. Around 65% of patients treated with older drugs such as  adalimumab or methotrexate (Trexall) get relief, for the remaining 35% JAK inhibitors can provide and effective alternative.

A noteworthy advantage of JAK inhibitors is the ability for them to be taken orally. Older drugs needed to be administered by injection or infused by doctors into the bloodstream. Having a drug that can be given as a pill increases ease of use and patient compliance.

The Other Side of the Story

As with most drug therapies, JAK inhibitors are not without side effects. As the immune system is halted to a degree, patients taking these drugs can be prone to developing infections. However, as the half-life of these drugs is short if a patient stops taking them their ability to fight infections will restore relatively rapidly.

JAK inhibitors effect a protein necessary to produce red blood cells. Some patients can, therefore, become anaemic when on this therapy. White blood cell count can also be lowered, compounded the risk of reduced ability to fight infection.

JAK inhibitors could increase cholesterol numbers but this can be easily overcome with secondary treatment using a statin drug, such as atorvastatin (Lipitor), at the same time.

Lastly, concerns have been raised that drugs that block immune system processes could increase the risk of cancer and blood clots.

It is therefore important to discuss the potential side effects with your treating doctor who will also be able to address whether there is the potential for drug interaction with any of your current medications.

The Future of Rinvoq

Earlier in 2019, market researcher EvaluatePharma ranked Rinvoq as the second most valuable pipeline drug in development. It was predicted that Rinvoq would be the second-biggest new drug launch of 2019. At the time, EvaluatePharma estimated that the drug would generate sales of $2.2 billion by 2024. Currently, however, EvaluatePharma has increased this figure to a huge $2.5 billion in projected sales of Rinvoq by 2024.

 


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ANRF
Article Author
Arthritis National Research Foundation
arthritisresearch@curearthritis.org

The Arthritis National Research Foundation's mission is to provide initial research funding to brilliant, investigative scientists with new ideas to cure arthritis and related autoimmune diseases. Writing articles about the patients affected and the science being done to find a cure shows why we need to come together to #CureArthritis!

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