West Virginia University
Neurology

Author Of 1 Presentation

Disease Modifying Therapies – Risk Management Poster Presentation

P0385 - Risk factors for ocrelizumab infusion reaction in a rural Appalachian population (ID 1190)

Speakers
Presentation Number
P0385
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Ocrelizumab is an anti-CD20 monoclonal therapy for multiple sclerosis. The most common adverse reaction seen with ocrelizumab is infusion-related reaction (IRR). While the majority of these infusion reactions are mild in severity, some patients have a serious reaction or discontinue therapy. Additionally, the major randomized controlled trials, OPERA 1 and 2, and ORATIO, demonstrated IRRs at 34% and 40%, respectively. Risk factors for IRRs are not clearly established.

Objectives

Determine current rates of ocrelizumab infusion-related reactions, length of infusions, and risk factors for infusion-related reactions amongst multiple sclerosis patients in a rural Appalachian clinic.

Methods

226 patients were analyzed for IRR and associated risk factors. Statistical analysis was performed using IBM Statistics (Version 26), and P values ≤ 0.05 were considered statistically significant. Frequency of IRR was compared between groups using Fisher’s exact test, and binary logistic regression models were used to identify predictors of IRR. Means of normally distributed linear variables were compared between groups using independent samples T test.

Results

79 of 226 patients had at least one IRR (35%). IRRs occurred 128 times per 900 individual infusion sessions, (14%). Of all the demographic and medical history variables evaluated, female sex was the only significant factor associated with having an IRR: females were 2 times more likely than males to have an IRR (P=.021). Additionally, patients who had an IRR during the initial induction therapy were 12 times more likely to have a subsequent IRR than patients without an induction IRR (p<.0001). The mean length of infusion was significantly longer in patients who had an IRR compared to those who did not, 241 minutes and 217 minutes, respectively (p<.0001).

Conclusions

Our study showed at least one IRR occurring in 35% of patients receiving ocrelizumab which is nearly identical to the rates reported in clinical trials. Similar to the 2019 study by W Conte et al, male sex was protective against IRR. Patients with IRR during initial induction dose carried a high risk of further IRR; therefore, this subgroup could benefit from more aggressive pre-medications. Not surprisingly, IRRs extended the length of infusions but only by an average of 24 minutes. This does make the full length of an ocrelizumab infusion about 6 hours when pre-infusion and post-infusion waits are included. Due to sparse treatment centers, lengthy infusions create a travel challenge for rural Appalachian patients. Studies are ongoing to test the safety of faster infusion rates with ocrelizumab which would benefit our patient population substantially.

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Presenter Of 1 Presentation

Disease Modifying Therapies – Risk Management Poster Presentation

P0385 - Risk factors for ocrelizumab infusion reaction in a rural Appalachian population (ID 1190)

Speakers
Presentation Number
P0385
Presentation Topic
Disease Modifying Therapies – Risk Management

Abstract

Background

Ocrelizumab is an anti-CD20 monoclonal therapy for multiple sclerosis. The most common adverse reaction seen with ocrelizumab is infusion-related reaction (IRR). While the majority of these infusion reactions are mild in severity, some patients have a serious reaction or discontinue therapy. Additionally, the major randomized controlled trials, OPERA 1 and 2, and ORATIO, demonstrated IRRs at 34% and 40%, respectively. Risk factors for IRRs are not clearly established.

Objectives

Determine current rates of ocrelizumab infusion-related reactions, length of infusions, and risk factors for infusion-related reactions amongst multiple sclerosis patients in a rural Appalachian clinic.

Methods

226 patients were analyzed for IRR and associated risk factors. Statistical analysis was performed using IBM Statistics (Version 26), and P values ≤ 0.05 were considered statistically significant. Frequency of IRR was compared between groups using Fisher’s exact test, and binary logistic regression models were used to identify predictors of IRR. Means of normally distributed linear variables were compared between groups using independent samples T test.

Results

79 of 226 patients had at least one IRR (35%). IRRs occurred 128 times per 900 individual infusion sessions, (14%). Of all the demographic and medical history variables evaluated, female sex was the only significant factor associated with having an IRR: females were 2 times more likely than males to have an IRR (P=.021). Additionally, patients who had an IRR during the initial induction therapy were 12 times more likely to have a subsequent IRR than patients without an induction IRR (p<.0001). The mean length of infusion was significantly longer in patients who had an IRR compared to those who did not, 241 minutes and 217 minutes, respectively (p<.0001).

Conclusions

Our study showed at least one IRR occurring in 35% of patients receiving ocrelizumab which is nearly identical to the rates reported in clinical trials. Similar to the 2019 study by W Conte et al, male sex was protective against IRR. Patients with IRR during initial induction dose carried a high risk of further IRR; therefore, this subgroup could benefit from more aggressive pre-medications. Not surprisingly, IRRs extended the length of infusions but only by an average of 24 minutes. This does make the full length of an ocrelizumab infusion about 6 hours when pre-infusion and post-infusion waits are included. Due to sparse treatment centers, lengthy infusions create a travel challenge for rural Appalachian patients. Studies are ongoing to test the safety of faster infusion rates with ocrelizumab which would benefit our patient population substantially.

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