Once-Daily Rheumatoid Arthritis Pill Shows Promise

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rheumatoid arthritis baricitinib EULAR 2012 congress

Ed Keystone, MD, of the University of Toronto, presented preliminary findings from a trial of a one-a-day Rheumatoid Arthritis medication, baricitinib.

A new, once-daily Rheumatoid Arthritis pill looks set to revolutionize treatment of the autoimmune joint disease as trial data is released for Baricitinib. Last month the FDA approved a twice-daily drug for RA called tofacitinib and some rheumatologists are singing the praises of this latest move towards the ‘holy grail’ of RA treatment, the one-a-day oral medication. Rheumatoid Arthritis, which can cause symptoms of fatigue, fever, joint swelling, and neck pain, is thought to affect 1.3 million people in the US, with three times more women than men affected.

Patients currently have a range of biologics, anti-inflammatories, and immunosuppressants available to control and manage symptoms, such as neck pain, of the autoimmune joint disease. However, drugs such as Humira, Orencia, and NSAIDs, do not work for some patients, or cause intolerable side-effects, making news of a new RA medication extremely welcome for those suffering chronic pain.

New Drugs for Rheumatoid Arthritis

Presenting the findings of a Phase IIb trial at the European League Against Rheumatism (EULAR) Congress 2012, lead author Edward Keystone, MD, noted that there were significant differences in response compared to placebo just two weeks into the trial with baricitinib. The medication is being investigated by Eli Lilly & Co and Incyte Corp and is a JAK1/JAK2 inhibitor like Pfizer’s tofacitinib. What this means is that it works differently to medications such as methotrexate, oral steroids, NSAIDs, and biologics and is being viewed as something of a shift in the paradigm for treating Rheumatoid Arthritis. A particular benefit of this new type of drug is that it is cheaper to manufacture than other RA medications.


Significant RA Symptom Improvement with Baricitinib

In this study, which included 301 patients with active RA on a stable dose of methotrexate, baricitinib was given in doses of 1mg, 2mg, 4mg, and 8mg once daily, with a control group given a placebo instead. In the groups taking the 4mg and 8mg dose of baricitinib, 76% achieved the primary outcome of the study, which was a 20% improvement in joint swelling at twelve weeks according to the American College of Rheumatology 20 (ACR20). In the placebo group, 41% of the patients achieved this response, making the difference statistically significant in favor of baricitinib.

RA Symptoms Reduced by One-A-Day Pill

Other factors assessed in the study included secondary endpoints of ACR50 and ACR70, with 35% of those taking 4mg daily, and 40% of those taking 8mg daily achieving a 50% improvement in joint swelling (vs. 10% of the placebo group). A 70% improvement in RA joint swelling was seen in 23% of the 4mg group and 30% of the 8mg compared to 2% of the placebo group in the trial.

rheumatoid arthritis jak1 jak 2 pathway medication target

The JAK1/JAK2 signalling pathway is the target of these new RA medications.

Side-Effects of Baricitinib

Adverse events associated with baricitinib were experienced by some patients, with infections being the most common. However, differences between placebo and treatment groups were minimal in this regard, with 12% of the controls suffering infections and 14% of the baricitinib group developing infections during the trials. No deaths occurred in the active treatment groups, although seven serious adverse events were reported in six patients: two in the placebo group, four in the 2mg group, and one in the 8mg group.

The Future of Rheumatoid Arthritis Treatment

A large number of patients with Rheumatoid Arthritis are unresponsive to currently available treatments and so these new drugs, working on inhibiting the important JAK1/JAK2 signalling pathway, could represent a viable choice for such patients. More research needs doing to determine the efficacy and safety of these new types of medication for RA, and patients responding well to current treatments such as methotrexate are unlikely to be switched to these new drugs even if approved. Although the study’s authors are wary of comparing baricitinib to tofacitinib they did note that side-effects and efficacy appear similar, with baricitinib offering the added advantage of being a one-a-day pill for Rheumatoid Arthritis.

Reference


European League Against Rheumatism (EULAR) Congress 2012. Abstract #LB0005. Presented June 8, 2012.

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