Pretreating Ocrevus Patients with Multiple Antihistamines and Liquids Lowers Infusion Reactions by 60%, Study Reports

Pretreating Ocrevus Patients with Multiple Antihistamines and Liquids Lowers Infusion Reactions by 60%, Study Reports

Pretreating multiple sclerosis patients with antihistamines more extensively and with hydration can significantly reduce — by 60% — the likelihood of infusion-associated reactions that are the most common side effect of Ocrevus (ocrelizumab) use, a pilot study reported.

Data also found that older and male MS patients are less likely to have such reactions to this therapy, while heavier patients are more likely.

The research, “Reduction in ocrelizumab-induced infusion reactions by a modified premedication protocol,” was published in the journal Multiple Sclerosis and Related Disorders.

Infusion-associated reactions (IARs) to Ocrevus — an approved MS therapy developed by Genentech, owned by Roche — were seen to decrease in rate and severity with subsequent administrations in primary progressive MS patients who took part in the ORATORIO Phase 3 trial (NCT01194570). But they remain a challenge for many on Ocrevus, and may cause patients to stop treatment at less experienced centers.

Aiming to lessen the risk of IARs, a team at The University of Chicago established a modified premedication protocol, based on one previously designed for Lemtrada (alemtuzumab), an MS therapy marketed by Sanofi Genzyme. Specifically, the scientists compared the rate of IARs prior to and after implementing the protocol, and evaluated predictors of IARs in patients receiving Ocrevus.

A total of 207 patients were treated with Ocrevus at the University of Chicago Medicine MS Clinic. Their median age was 47 years, and 131 (63.3%) were women. The night before a September 2017 infusion, 110 patients (72 women, 65.5%) on the modified premedication protocol were instructed to take cetirizine (10 mg), ranitidine (75 mg), and encouraged to drink water or other liquids for hydration. Cetirizine is an antihistamine used to relieve allergy symptoms; ranitidine is an antihistamine used to lower stomach acid production.

This regimen was repeated the next day, prior to arrival at the clinic.

Immediately before an Ocrevus infusion, these patients were also given the antihistamine diphenhydramine at 50 mg and the corticosteroid methylprednisolone at 125 mg, both via intravenous infusion, as well as acetaminophen (650 mg), an oral pain and fever medication.

Researchers then reviewed data on all patients using Ocrevus at their center from March 2017 – when the medicine entered the market – to April 2018 to compare IAR rates between those on the modified premedication protocol and those on standard pretreatment (methylprednisolone at 100 mg and an antihistamine like diphenhydramine) prior to infusion. Parameters such as age, race, smoking status, sex, body mass index (BMI), years since MS diagnosis, and number of prior disease-modifying therapies (DMTs) taken were recorded.

IARs were defined as any adverse event occurring within 24 hours of receiving the first dose of Ocrevus. Reactions were either documented by a nurse during the infusion visit, or by telephone or in a follow-up visit if occurring later.

Results showed a 10% overall prevalence of IARs in patients on the modified premedication protocol, compared to a 21.6% prevalence in those on the standard protocol. Importantly, the odds of IARs with the modified premedication protocol were reduced by 60%, data showed. All infusion reactions were either grade 1 or 2, meaning mild or moderate.

Subsequent analysis found that the odds of IARs were lower with increasing age (6%) and male sex (66%), and increased (7%) with higher BMI. The researchers attributed the lesser risk associated with age and sex to the lower level of circulating immune B-cells (known to be involved in MS development, and the target of Ocrevus) in older and male patients. The reported increase in chronic systemic inflammatory responses linked to obesity may help explain the rise in reactions with a higher BMI.

Race and smoking did not affect the rate of IARs.

Researchers concluded that their modified premedication protocol “significantly decreases rates of IARs by 60%, and suggests that the additional premedication regimen is beneficial” to patients taking Ocrevus.

They emphasized that further studies are needed to confirm these results.

José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has studied Biochemistry also at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario, in London, Ontario. His work ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has studied Biochemistry also at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario, in London, Ontario. His work ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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6 comments

  1. Sherri says:

    I had an anaphylactic reaction to Ocrevus during the second dose (the one given two weeks apart) of my first infusion last December. At first, I thought my IV infiltrated because my arm was hurting. The nurse was checking it and my vital signs. Apparently the IV was still patent (or so I was told later). My blood pressure and body temperature dropped, my throat was scratchy, I developed a rash on the extremity Ocrevus was being infused into, I had difficulty breathing and I lost consciousness for a few minutes.

    My husband was scared beyond belief. Several nurses were at my side by then. One was manually withdrawing the Ocrevus out of my line before she started a bag of saline. My neurologist was on the phone with them during this episode.

    After about an hour, I was given more methylprednisolone and Benadryl. Ocrevus was started again, but at a much slower rate. I made it through that infusion six hours later. Within an hour after the infusion stopped, my body was still very itchy, and the headache (migraine) started.

    Six months later (August 2018), I went in for my next infusion. They pre-medicated me like normal, but also ran a bag of saline concurrently with the Ocrevus, and ran the rate slower than normal; I was there for 8+ hours. I made it through that one just fine. Once again, I had the overall itching and migraine afterwards.

    Since then, I’ve experienced non-stop menstrual spotting. I won’t go into detail, but I did have tests run, and I do have a fibroid in my uterus. Biopsy done, and it’s not malignant.

    According to adverse events in trials (OPERA I & OPERA II), fibroids, ovarian cysts and uterine cancer were diagnosed. Tomorrow I meet with the gynecologist to discuss treatment options.

    At this time, I think I’m going to hold off doing another round of Ocrevus.

    But back to the story here…IV fluids were a must for me when I did the infusions to help prevent adverse reactions. I highly recommend people print out this story to share with their neurologists if they are thinking about, or plan on continuing this treatment.

    • Sherri says:

      Correction: It was eight months later that I had my second scheduled infusion. I should have had the infusion at the end of June, but there were various issues with obtaining the infusion free from Genentech based upon the 2016 taxes, and my total out-of-pocket expense from my new insurance company. Only when I moved out-of-state and went back to the original insurance plan that I had in 2017 did I qualify to receive it free again. That’s why I had a delay in getting the next round.

  2. Stacey says:

    Oh wow that is good to know as I am supposed to be starting this treatment in January, Iam definitely going to do my homework on this one, I was previously having tysabri but unfortunately it is not working anymore, cheers

    • Melinda says:

      Me too, I start this therapy in January and my Neurologist assured me that it is a safe medication with minimal side effects. Of course, I have been doing my own research and I’m coming to the conclusion that the bad outweighs the good. I think I’m going to pass on this one.

  3. Luke says:

    I’m two years into this treatment on December 28 in Dallas. I’m male, turned 67 a few months ago, diagnosed at age 60 with RRMS, but probably had MS decades earlier and ignored the oddities related to this malady.

    I’ve had no side effect from the injections, but get rather drowsy from the Benadryl on our 200 mile trip from Dallas to where we live.

    Best to all who have commented here.

  4. Thanks so much for reviews. I was thinking about taking Ocroverus. But after I am at a new Neuro. Mine moved. Trust factor just not there yet. and
    Reading up on it and my Dr. Talking to me about it. And now your reviews. No thanks to the Big O infusion. You all sent it home for me. Thanks to all. Almost 15 years of Multiple Sclerosis. Took almost all the meds. I will wait for the next pot at the end of the rainbow. Have a good day. Al my friends.

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