Discussion
DISEASE, RECRUITMENT
This open‐label, single‐arm, nonrandomized study is among the first to assess the safety of the at‐home infusion of ocrelizumab. Leveraging the shorter infusion regimen, at‐home administration did not increase the incidence of IRRs compared with the SaROD trial of the shorter infusion protocol for administering ocrelizumab, and no cases of severe or life‐threatening IRRs were experienced, which highlights the safety of at‐home infusions. Overall, patients reported increased confidence and comfort during home infusions through PROs administered pre‐ and post‐infusion compared with their last infusion received at an infusion center.Our study is among the first to evaluate home infusion for the administration of ocrelizumab, and findings from this cohort provide evidence of the safety, feasibility and patient satisfaction that can be achieved with at‐home infusions. Our study supports the use of home infusions as another safe and efficient alternative option for administering ocrelizumab to stable MS patients. Limited data on the administration of at‐home infusions are available, which highlights the importance of these study findings as providers of MS patients find newer ways to administer ocrelizumab. It is important to note that available studies in other DMTs and antibiotic treatment administration have shown comparable safety and efficacy with at‐home treatments compared with standard clinical settings. In a pilot crossover clinical study, patients with MS were randomized to receive usual care or home infusions of natalizumab, and were then switched to receive the alternate treatment.The mean infusion time achieved in this study was 2.5 h, which is consistent with the historical control data of 2.4 h reported in the SaROD study.The findings from this study are also unique because they provide valuable insights into the patient experience with at‐home infusion treatments through PRO questionnaires. The increased use of PRO scales in clinical studies enhances our understanding of patients' feelings about the treatment experience, their interactions with healthcare providers and circumstances that may influence their adherence to treatment. A survey study of patients with MS who received treatment at an infusion center reported that 83% of patients who received natalizumab or ocrelizumab had to take time off work or study for treatment infusions, and 60% responded that they would consider home‐based infusions.The results presented here should be interpreted within the context of the study limitations. Patient recruitment methods from a single center may limit the generalizability of these results for the overall MS population. The outcomes from this study were also only evaluated for a single home‐based infusion experience; therefore, further studies over longer periods that include multiple infusions should be conducted to extend these results. Historical control data were also used for comparison in the present study, which may introduce bias, although the SaROD study had similar characteristics in terms of sex, race, age and MS disease type. Studies that include direct comparison arms are needed; nevertheless, the findings of this study are consistent with and comparable to similar prior studies. Additionally, some of the PRO questionnaires included in this report are not validated; however, they do include very specific questions tailored to the home‐based infusion process that can provide valuable insights that established PROs may not address. While there are study limitations to consider, the findings presented here add useful evidence for the use of home‐based infusion therapy. Future studies that are designed to specifically address safety and efficacy concerns regarding at‐home infusions can further substantiate our findings.Overall, the findings presented in this study demonstrate the safety and feasibility of at‐home infusions for patients with MS. We report IRR and overall AE incidence rates comparable to those reported in other clinical studies involving home‐based infusions. This study also provides positive PRO data regarding the patient experience with at‐home ocrelizumab infusions and reveals factors that contribute to patient treatment satisfaction with infusion therapy. The reduction in time spent undergoing treatment through at‐home infusions can increase convenience and patient satisfaction, as well as positively impact treatment adherence without compromising the clinical benefit.