Rituxan Injections as Safe as IV

The British Journal of Haematology has published the results of a phase 3 study that shows that subcutaneous Rituxan (and injection) is just as safe as the intravenous method.

Many of us have had Rituxan (or MabThera as it is known in some parts of the world) through intravenous administration. That was my experience -- six hours in a chair, the Rituxan very slowly dripping into a vein. The slow rate was necessary, since it is common for patients to have an allergic reaction, especially to the first round. The slow drip helps to control the reaction. I did have a reaction to the first round, and my five later rounds were a little quicker -- but not all that quick (4-5 hours).

Subcutaneous Rituxan, given a shot under the skin, has been available in the U.S. for a couple of years now, and even longer in other parts of the world. It is much, much quicker -- only 5 to 7 minutes in most cases -- and is available to patients who did not have allergic reactions, or whose reactions were under control. The subcutaneous version of Rituxan is called Rituxan Hycela in the U.S., and it was approved by the FDA based on clinical trials.

The BJH article reports on another clinical trial, this one from Spain. Its main goal was to test the safety of subcutaneous Rituxan by comparing it to IV Rituxan. The trial looked at the two types of Rituxan as part of a combination with chemotherapy. It found that most patients (there were a totla, of 111 with Follicular Lymphoma) did have some kind of reaction, including numbness, fatigue, and rash. About 38.6% of patients had a grade 3 or greater reaction (considered the most serious), but about half of them came from the chemo, rather than the Rituxan. In comparing the two types of Rituxan, there was no difference in safety. In other words, subcutaneous is as safe as IV Rituxan.

The study also tried to measure some other things, including effectiveness (seems to be as effective, but they're still gathering some data). More importantly, they tried to also measure Quality of Life.

They did this by asking patients to fill out a survey, and about 60% of them did. They found that Quality f Life was as good or better with subcutaneous Rituxan. This makes a lot of sense -- my QoL would have been greatly improved if I didn't have to send 4-6 hours on six consecutive Fridays sitting in a chair with an IV in my arm. In general, the cost is less, too, since the patient doesn't need to be supervised for that long. Patients also said that they didn't have any problems with moving around, taking care of themselves, or just doing their usual activities, and didn't have problems with long-term pain or anxiety and depression.

In some ways, the study confirms what we already knew -- subcutaneous Rituxan is as good as the old IV version, and in some ways even better.

But more importantly, the study focused on why it's even better, and that's where the Quality of Life data comes in. Safety and effectiveness are very important, obviously -- we want all of our treatments to be effective, and to not cause additional health problems. But so few studies now include Quality of Life data that would show that a new treatment is worth the cost because it allows us to not just stay alive, but to live a life that's meaningful and fulfilling.

This is a good time to remind you that the good folks at Lymphomation.org are still collecting signatures for a petition that asks the FDA to require that ALL clinical trials collect Quality of Life data. If you haven't had a chance to read the petition and sign it, take a few minutes to do it now.

There are lots of ways to measure success for a treatment. Let's make sure that researchers measure the ones that matter.