RA Patients’ Long-Term Response to Rx

Secukinumab brought long term improvement to RA patients who did not respond to other treatments

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Rheumatoid arthritis can be treated with a variety of medications, depending on what works best for a patient. Sometimes, however, effective medications come with unwanted side effects.

A research group recently studied secukinumab, an injectable antibody made by Novartis Pharmaceutical, to determine its effectiveness and safety for long-term use.

These researchers found the medication to be effective, but more than half the patients experienced mild to moderate side effects.

Secukinumab has yet to be approved by US regulators for use in patients.

"Discuss RA treatment options with your rheumatologist."

Dr. Mark C. Genovese from Stanford University in California and his team conducted this research.

This study was a continuation of a previous study investigating the effectiveness and safety of secukinumab. This research was a Phase II clinical trial where researchers looked at the long-term safety of the medication from weeks 20 to 60 and its effectiveness from weeks 20 to 52.

Medications are studied in phases, and the Food and Drug Administration (FDA) uses research findings from all phases in its decision to approve a medication. Sekukinumab is still under investigation and is not currently approved by the FDA.

The study involved 237 rheumatoid arthritis (RA) patients who had failed to respond to other anti-rheumatologic medications and biologics and who were presently being treated with methotrexate.

The patients were split into five groups and received 25, 75, 150 or 300 mg of secukinumab or placebo (fake medication) for 48 weeks. Doses were adjusted based on assessments of effectiveness at 16 weeks. At that point, patients in the placebo group were given 150 mg of secukinumab until the end of the study.

The results of the study showed that patients who took 150 mg of secukinumab saw improvement in their RA through week 52 of the study.

Between weeks 20 to 60, 65 percent of the patients experienced side effects. Most reactions were mild to moderately severe and included cold-like symptoms in 13 percent of the participants, RA symptoms in about 6 percent and urinary tract infections in about 5 percent of the participants.

More serious side effects were seen in 29 patients, of which six were due to infection. Three people developed different cancers. No deaths were reported up to week 60 of the study.

Some patients dropped out of the study, citing lack of benefit from their treatment. Eleven of these were in the groups that initially received 25 or 75 mg of secukinumab, two were in the 300 mg group and two were in the placebo group. No one left the 150 mg secukinumab group due to lack of treatment benefit.

The researchers noted that a limitation of their research was that patients were included in this study no matter what their previous treatment was. This might have affected the response rate to secukinumab.

“Patients with active RA who had failed to respond to disease-modifying antirheumatic drugs and other biologics showed an improvement in signs and symptoms of their disease with longterm treatment with 150 mg of secukinumab," Dr. Genovese and team wrote.

“The frequency of adverse events remained stable over time and secukinumab had a consistent safety profile over 60 weeks,” they wrote.

This study was published in the January issue of The Journal of Rheumatology.

A grant from Novartis Pharma provided funding for this study.

The research team did not disclose any conflicts of interest.

Review Date: 
February 20, 2014
Last Updated:
February 21, 2014