Q&A 56: Natalizumab switching: adverse events on Tyruko

Patients can experience the nocebo effect when they switch to generic or biosimilar drugs. Are these reports due to the nocebo effect?

Case

I am a 33-year-old female diagnosed with highly active RRMS 2.5 years ago following my first symptomatic relapse, which caused the loss of sensation in both legs and up to my chest. The loss of feeling lasted around six months. I started Natalizumab (Tysabri) around 6 weeks after the onset of this relapse.

I am doing very well on Tysabri with few side effects and no relapses. I generally have no ongoing MS symptoms (apart from some fatigue). 

I am part of an online MS Tysabri group and saw that patients across England are being switched to Tyruko with no choice because NHS England has signed a new deal for the cheaper biosimilar drug Tyruko, so Tysabri will no longer be offered. 

Many people who have switched have reported not being told about the medication change in advance. My hospital has not informed patients about an impending change in medication, though I have reached out to my MS nurse, who says they are making the switch very soon.

I am feeling anxious about this change, so I have been doing some research. I read that the effectiveness of Tyruko vs. Tysabri was based on a small study (around 240 patients and only 30 participants specifically switched from Tysabri to Tyruko).  I am also concerned from reading other people’s experiences of both new relapses and suffering new intolerable side effects following the change from Tysabri to Tyruko (from a national Tysabri MS group). I have attached an article from the Times about a Charing Cross lady suffering from harmful side effects since being changed. 

I think I have the following options, but I wanted to check with you whether there is anything else:

Q1. Switch to Tyruko. As outlined above, I am concerned about doing this and relapsing. Also, are we sure that Tyruko is as safe as Tysabri about breastfeeding and conception? (I have a baby and plan to have more children)

Q2. Switch to Tysabri subcut. This would also help with childcare as it’s quicker than infusion. Also, the nurses usually struggle with my veins for the cannulas, so there are almost always multiple attempts to cannulate. Do you think subcut Tysabri will continue to be offered, or will this be withdrawn as well? And efficacy-wise, I’ve read conflicting material about its effectiveness compared with Tysabri IV. 

Q3. Switch to a different DMT entirely. There are multiple issues here, including considerations regarding breastfeeding, future conception, Tysabri withdrawal rebound, and general efficacy. 

I’m concerned and really keen to hear your thoughts on these, or as I mentioned, any other options (eg any possible route to stay on Tysabri IV, or other).

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Prof G’s answer