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Pill for Rheumatoid Arthritis Works as Well as Shot

Experimental Pill Tofacitinib Could Offer Option for RA Patients Who Dislike Injections

Tofacitinib vs. Humira

The new, 12-month study involved 717 people with moderate to severe rheumatoid arthritis who had not fully responded to methotrexate. They continued methotrexate and also took the pill tofacitinib, Humira injections, or a placebo pill.

Among the findings:

  • About half of people who received tofacitinib or Humira had a significant improvement in disease activity and symptoms after six months of treatment, compared with about one-fourth of those who received a placebo.
  • Scores on a questionnaire that asked about dressing, arising, eating, walking, hygiene, reach, grip, and activities improved more than twice as much in people taking tofacitinib or Humira, compared with placebo.

People on tofacitinib and Humira had similar improvements, van Vollenhoven says.

Safety Results

Over a six-month period, serious side effects occurred in 5% of those on a lower tofacitinib dose, 4% of patients on a higher dose, and 3% of patients on either Humira or placebo.

There were two deaths: one from bloodstream infection in the lower-dose tofacitinib group and one cardiac arrest in the Humira group. Also, two people in tofacitinib developed lung tuberculosis.

People taking tofacitinib were also more likely to experience drops in white blood cell count and increases in LDL "bad" cholesterol levels. In findings that muddied the water, however, there was also an increase in HDL "good" cholesterol levels in some patients on tofacitinib.

"As with all drugs, we need long-term information on safety. But from both an effectiveness and safety view, tofacitinib looks to be very promising," Matteson says.

When Other Drugs Fail

Another study presented at the meeting was the first to evaluate tofacitinib in people who weren't helped by other biologic drugs or who could not tolerate them.

In the 399-person study, about 45% of people on tofacitinib had a significant improvement in disease activity and symptoms after three months of treatment, compared with about one-fourth of those who received a placebo.

The company also is testing tofacitinib for other autoimmune conditions such as psoriasis and inflammatory bowel disease. One study found no benefit for Crohn's disease.

These findings were presented at a medical conference. They should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.

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