This week I received my 12th Benlysta infusion, and am glad to report moderate success with it as a contributor to controlling my lupus. While I had keenly anticipated it might be as miraculous as the Rituxan (Rituximab) infusions I received several years ago, it has fallen far short of that hope. However, the drug I received during the phase three clinical trials of Rituximab proved to have remarkable effectiveness for some lupus patients, but treatment with it presented grave danger for others.
While I entered a five-year dramatic near remission of my lupus after receiving just two infusions of Rituximab, a few unfortunate patients in the clinical trials lost their lives to a fatal brain infections. A normally harmless common childhood virus was re-awakened in some of the clinical trial patients, causing their untimely deaths. The number of these deaths was compared to the total number of patients in the trial, and it was clear the fatalities were too many to be a coincidence.
Benefits of effective drugs may not outweigh the risks
The Rituximab deaths demonstrated that lupus patients seemed to have too much risk to take the drug, and the excitement about Rituximab as a treatment for lupus cooled off quickly. The FDA did not approve it and many insurance companies will not pay for Rituximab to treat Lupus. Although Rituximab is FDA approved and widely used with outstanding results for rheumatoid arthritis, certain cancers and many other auto-immune diseases, Rituximab proved much too risky for lupus patients. The potential benefits of Rituximab for Lupus clearly did not outweigh the great risks.
I also thank God for many answered prayers and His gracious protection through the clinical trial, and that I was spared from developing a horrible infection. I am thankful for the many people who prayed for me during the time I was receiving Rituximab* infusions, knowing there were possible great risks, and even a remote possibility of death. Although I was more concerned about a possible allergic reaction, there was an even greater risk from infection revealed during the trial.
So, I now continue to take Belimumab infusions, and do enjoy its moderate help with controlling my lupus. Still, I cannot help but wonder how I might feel right now if Rituximab had been safer, and if it were still available to me. One of the important issues patients must realize when they take part in clinical trials, is that, although they may feel great in response to new drugs being investigated, the medication being studied may not continue to be available. If access to drugs taken in a clinical trial stops and they are not approved by the FDA, then participants must be ready to accept a return to using less effective drugs and a possible return to more active lupus.
“Okay” with safe drugs is better than dangerous miracles
For me there is some clear amount of disappointment to cope with after having received both Rituximab and Belimumab infusions. But, still I am very thankful for the five years of dramatically improved health that I enjoyed after Rituximab. I am also very thankful to for the slower, but clearly modest improvement of my lupus after ten months of Belimumab infusions.
Although after almost one year of Belimumab I hoped to feel absolutely wonderful, instead have to describe how I feel today as just “okay.” Okay is better than where I was a year ago, and that is still very important progress in treating my lupus. It is not miraculous, like Rituximab seemed to me, but it gives acceptable improvement. I’ll take it and thank God daily for the ability to receive this helpful and safer FDA-approved treatment.
Participation in clinical trials makes a difference
It is also very important to me to know that my participation in a clinical trial contributed to the greater process of helping find new drugs that are safe and effective for treating lupus. Even though the drug I took did not ultimately become a help to future lupus patients, the clinical trial helped in other ways. If not for patients like me, being willing to put their hopes and health at some level of risk, new drugs would never be found for lupus.
The safest trials to take part in are phase three clinical trials, when medicines are tested that have already proven effective in phase one and phase two trials. The phase three trials help verify appropriate doses, and measure how effective the drugs are in treating a specific disease. Phase 3 trials help doctors know 1) how much medicine to give, 2) how often to give it, and 3) how well the medicine works. Progress in finding these new drugs would never be reached without patients and their doctors being willing to participate in the lupus adventure and risks of joining a clinical trial. I am still grateful for that opportunity to make a difference.
*[Errata: The incorrect word “Benlysta” was deleted and correct word “Rituximab” was inserted after publishing.]
Other posts about Rituxan and Benlysta:
Lupus Rituxan treatment denied by insurance company
Pending FDA approval of new lupus drug Benlysta
Lupus, and Benlysta in my future…
Benlysta Infusions for Lupus – Day One
Benlysta infusions for lupus – Day 15
Benlysta Infusions for Lupus – Day 30
Benlysta Infusions for Lupus – Day 60
Benlysta Infusions for Lupus – Day 90 – Thanksgiving
Lupus and Benlysta after 21 weeks
Lupus post-infusion infection, steroids and the E.B. effect
Benlysta & Rituxan infusions for Lupus: the tortoise and the hare
Lupus and Benlysta – 25 Weeks and Infusion #8
Lupus, Benlysta infusions and almost glorious mornings
Lupus and postponing a Benlysta infusion
Lupus, singing and a visiting hummingbird
Lupus and Benlysta after 7 months – Infusion #9
Benlysta infusion #10 while pondering the good, the bad and the ugly of lupus
Diagnosis and Treatment of Lupus: Fact #12 – Lupus requires multiple medicines!
Prognosis and Hope: Lupus Fact #28 – Normal life span expected with current treatment standards
Prognosis and Hope: Lupus Fact #31 – Lupus research lengthens lives!