Rituxan safe for long-term use in rheumatoid arthritis

Rituxan (rituximab) has a consistent safety profile through multiple courses over 11 years of observation, according to a new long-term study published in the online edition of The Journal of Rheumatology.

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The research, led by Ronald F. van Vollenhoven, MD, chief of the Unit for Clinical Therapy Research, Inflammatory Disease at Karolinska Institute in Stockholm, Sweden, was based on a pooled observed case analysis of data from 3,595 patients with moderate to severe, active rheumatoid arthritis (RA) in a global clinical trial program more than 11 years. The study represented 2,854 additional patient-years of follow-up with the inclusion of another 401 patients treated with Rituxan.

Dr van Vollenhoven“The importance of the study lies in the fact that rheumatoid arthritis, a serious disease of the joints, requires many years of treatment, and there is always the concern that new side effects will emerge with time. Thankfully, in this long-term study, there were no new safety signals detected, even with the additional years of exposure from the previous report,” Dr Vollenhoven told Formulary Watch.

The study offers the longest observation time of all studies published to date, Vollenhoven added.

No new safety signals or increasing reporting rates of any types of adverse events were observed with increasing duration of exposure to Rituxan, according to the Vollenhoven. The overall serious infection event (SIE) rate was 3.76/100 PY (2.71/100 PY in patients observed for > 5 yrs) and comparable with rates reported previously at 9.5 years (3.94/100 PY and 3.26/100 PY, respectively).

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The incidence of adverse events was the highest during the first 6 months of exposure, mainly attributed to infusion reactions. The rates of adverse events declined and reminded stable throughout the observation time.

In addition, the rates of adverse events and serious adverse events remained similar in the Rituxan all-exposure, Rituxan long-term and placebo populations, while serious opportunistic infections remained rare. The most frequent events reported were lower respiratory tract infections, predominantly pneumonia (2%).

The study was fully sponsored by Genentech (Roche).

In related news, Genentech initiated a phase 3 clinical trial investigating the use of Rituxan in patients with pemphigus vulgaris (PV), a rare, chronic and potentially fatal, blistering skin disease. The aim of the study, called PEMPHIX, is to determine the efficacy and safety of Rituxan for the treatment of PV. The current standard of care includes high doses of corticosteroids taken for several weeks and corticosteroids in combination with the off-label use of corticosteroid-sparing immunosuppressive drugs for many months, which can cause significant, long-term side effects, according to Genentech.

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