Rheumatoid arthritis (RA) patients may suffer needle pricks no longer if a new pill, tofacitinib, joins the platform of joint protectors following approval by the FDA.
The twice-daily pill functions by essentially muffling the immune system’s attack on its own joints and organs; according to experts, this makes it a therapy that gets to the point sans syringe and discomfort.
"It’s pretty important and pretty exciting, and some have described it as a biological drug in a pill," Jeffrey R. Curtis, MD, MPH, director of the Arthritis Clinical Intervention Program at the University of Alabama at Birmingham told WebMD Health News.
While previous biologics have done their share in transforming RA treatment, they have always required supplementary injection to function properly. Coupled studies published in the New England Journal of Medicine describe the composition of the new quasi-biologic and confirm that it can be just as comfortable in its singledom as comparable drug, Humira.
The studies found that pills like tofacitinib reduce the amount of swelling and pain in joints for twice as many patients compared to those who were administered a placebo. Comprised of a subject pool of more than 1,300 RA sufferers, the studies observed the immediate affects of the pill on patients. Researchers noted that significant changes in physical comfort were observed, but could not apply any longevity to such results as the studies have yet to reach mature status.
Currently, the FDA is considering whether it should approve tofacitinib or not based on both the above fact as well as the potential for the pill to accumulate numerous side effects over its lifespan. As the drug serves to block Janus kinase enzymes inside the cell, thus acting earlier in the immune system’s response, tofacitinib is expected to have broader effects on the body. Side effects discovered in the study period were upper respiratory tract infection, headache, diarrhea and reduction of white blood cell count. Patients subjected to tofacitinib were also more prone to viral and bacterial infection, with two participants -- on the highest dose regimen -- contracting tuberculosis.
Despite these threats, a panel of advisors voted in May for the FDA to approve Pfizer’s new pill. The FDA’s decision, pending for this month, is expected to be delayed as more information has been requested from the organization to further inform its ruling.
EvaluatePharma estimates that if tofacitinib is approved by the FDA, it will generate sales of more than $1 billion each year. And if the FDA approves the pill on the grounds that it must be applied with methotrexate, some physicians say they’re still ready.
"Will I use it with every patient? Probably not because I will start with methotrexate," said Roy Fleischmann, MD. But if patients don’t respond to that cheaper, common choice, Fleischmann had few qualms about trying tofacitinib as an alternative.
That being said, some experts remain unclear regarding the nature of the relationship between methotrexate and tofacitinib -- a union the FDA may honor in their upcoming decision.
“Will this drug get added to methotrexate? Will [it be a] substitute for methotrexate? Will it be used before a biologic or after biologic failure? That will depend on experience, on talking to other doctors, on seeing what the insurance companies allow us,” Richard Furie, MD, chief of the division of rheumatology at North Shore Long Island Jewish Health System in New York concluded.