After waiting nearly 17 months with one setback after another, I texted a friend… “I’ll believe it, when the drug is actually inside my body”….lol.
Well now I can actually say that, because on Nov 6th 2017, I finally received my first two injections of a new anti IL-4 IL-13 biologic drug Dupilumab, and in doing so, became the first person in the world to receive the drug for the treatment of asthma outside of a clinical trial.
They gave me the 300 mg in my stomach and another 300 mg in my arm at the clinic. After a couple months I’ll give myself the injections at home.
Because my FEV1 is so low and because the drug is still considered experimental for the treatment of severe asthma, they want me to keep a diary to log any adverse reactions or side effects during the first month. It’s now been 24 hours since my first dose and knock on wood, no obvious allergy or side effects from the medication except for some minor fatigue which is normal.
This crazy journey began back in May of 2016 when I approached a representative of the company who makes the drug, Sanofi, about the prospects of obtaining it on a compassionate use basis. 6 months later with the help of Dr Wenzel and the other Pulmonologists who have taken care of me, the company approved the request and sent the required forms to UCSF where I receive my medical care. Because the drug had not yet been approved by the FDA for the treatment of asthma, it took the University’s internal review board a lot longer than usual to approve the request. In mid August of this year UCSF finally gave the green light for me to start the injections, but just few days later, seemingly out of the blue, the University were notified that Sanofi had cancelled their compassionate use program and that I would not be receiving the drug after all. As you might imagine, I was beside myself. I waited so long to get this opportunity only to be disappointed again. In my frustration and disbelief, I contacted the company rep. He was shocked as well and said he would make some call to see what happened.
As always, he came through and 5 days later I received word that the expanded use program had been reinstated and that I would indeed be getting the drug. This time the IRB approval only took two weeks and just a couple days after that while I was in the hospital for an another bad asthma flare, they brought the consent forms to my bedside for me to sign. And the rest as they say, is history.
It will probably be several months before I’ll know if the drug is helping, and being somewhat of a realist after having tired almost every medication and treatment available for asthma to no avail, Im not expecting a full blown miracle. But, if it can help reduce my exacerbations or the severity of them, even just slightly, I would classify that as a semi miracle.
Regardless of the outcome though, Im eternally grateful to be given early access this potentially life changing drug. A special thank you to my pulmonologists and the research coordinators at the the UCSF Airway Clinical Research Center, as well as Dr’s Gianluca Pirozzi and Sally Wenzel and the folks at Sanofi–Regeneron for making this happen.
To others out there who are suffering from this disease, this is why it’s so important to advocate for yourself.
Here’s the clinicaltrials.gov listing:
The Dupilumab compassionate use study (NCT03020810)intervention Details:
The patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks
This is a single-patient study.This study is being undertaken to determine whether dupilumab has efficacy in extremely severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every immunosuppressive drug, early access to a potentially effective therapy.
The patient will continue in the study indefinitely. Safety will be evaluated and serious adverse events will be reported.