In total, 46 physicians completed the survey (Germany, n=14; Spain, n=12; Portugal, n=10; Italy, n=10). The study sites were either at a practice/community health centre (24%, 11/46) or at a hospital/outpatient clinic (76%, 35/46). In total, 41% (19/46) of the physicians had >20 years, of experience in treating MS patients. As there were no major differences observed between cumulative responses from investigators participating from the four countries, the overall data are presented.
The benefit-risk ratio of ofatumumab was assessed as either very good (43%, 20/46) or good (57%, 26/46) by the investigators. None of the investigators gave neutral, poor or very poor as an answer (Figure 1). Most of the treating physicians (87%, 40/46) believed that the precise low dose of ofatumumab (20 mg) and the SC administration of ofatumumab, which promotes specific targeting of the lymph nodes, are advantages over other anti-CD20 therapies. Across all four countries, 91% (42/46) of the treating physicians responded positively when asked if the shorter B-cell repletion time after discontinuing ofatumumab therapy10 and, consequently, higher flexibility in treatment are advantages over other anti-CD20 therapies. Overall, 80% (37/46) of the treating physicians responded that this had an impact on their choice of therapy.
Route of administration (includes self-injection)
While determining the treatment for patients, the appropriate route of administration played a role as follows: 83% (38/46) of the physicians agreed with the statements that they respect patients’ relevant wishes and consider the patient’s expected compliance, 63% (29/46) responded that they consider possible side effects associated with route of administration and 54% (25/46) believed that capacity at the treating site must be considered (Figure 2a). Almost all of the physicians (98%, 45/46) believed that the SC route of ofatumumab administration is an advantage, and 83% (38/46) agreed that the SC route of administration will motivate them to use ofatumumab more frequently.
Even though the treating physicians had the ofatumumab pre-filled syringes used in the ASCLEPIOS trials in mind, the results regarding improvement of patients’ quality of life using the SC self-injection were positive (Figure 2b). To the statement that ‘SC self-injection of ofatumumab eases the burden for patients in terms of time’, most of the physicians (83%, 38/46) believed it to be completely true, 15% (7/46) believed it to be somewhat true and 2% (1/46) stated it as rather untrue. To the statement that ‘SC self-injection of ofatumumab eases the burden on the practice/practitioners’, 59% (27/46) believed it to be completely true, 30% (14/46) believed it to be somewhat true and 11% (5/46) were neutral. To the statement that ‘SC self-injection of ofatumumab eases the mental burden of therapy for patients’, 35% (16/46) believed it to be completely true, 41% (19/46) believed it to be somewhat true, 22% (10/46) were neutral and 2% (1/46) stated it as rather untrue. To the statement that ‘SC self-injection of ofatumumab improves patients’ quality of life’, 37% (17/46) believed it to be completely true, 39% (18/46) believed it to be somewhat true, 22% (10/46) were neutral and 2% (1/46) stated it as rather untrue.
Most of the physicians (93%, 43/46) were in favour of self-injection of ofatumumab at home after marketing authorisation of ofatumumab is granted. Despite having experience with the pre-filled syringe in the ASCLEPIOS trials and not the Sensoready® autoinjector pen, 30% (13/43) preferred self-injection of ofatumumab at home after the first injection, 12% (5/43) after the second injection, 37% (16/43) after the third injection and 14% (7/43) after four or more injections. Two of the 43 investigators (5%) did not specify the time point of self-administration at home.
Monitoring, premedication and therapy algorithm
Based on the knowledge at the time of the survey, 40% (18/46) (includes responses ‘yes, it will be my preferred therapeutic option’, ‘yes, frequently’) of the treating physicians would use ofatumumab in the therapeutic algorithm for treatment-naïve patients, 87% (40/46) for first escalation therapy and 68% (31/46) for second escalation therapy.
All investigators confirmed that they would like to potentially use anti-CD20 therapy as a long-term strategy. Among them, 41% (19/46) investigators would use with one or more of the following restrictions: lack of long-term data (89%, n=17), safety (84%, n=16) and family planning (53%, n=10) (Figure 3a).
Overall, 41% (19/46) of the physicians responded that they would monitor patients for 0.25–1 hour after the first ofatumumab injection in the hospital/practice, whereas 28% (13/46) would monitor for >1–2 hours and 30% (14/46) for >2 hours (Figure 3b).
During the course of therapy in clinical practice, treating physicians considered determining total B-cell count and number of B-cell types for monitoring the course of therapy in clinical practice as very important (37% [17/46] each) or important (43% [20/46] each), while serum neurofilament light (NfL) as very important by 7% (3/46) and important by 37% (17/46) (Figure 3c).
Most of the physicians would prefer to use antihistamines (89%, 42/46), steroids (94%, 44/46) or paracetamol (85%, 40/46) as premedication before administering the first ofatumumab injection in clinical routine; 11%–40% of the physicians preferred premedication before the second injection and 4%–28% preferred premedication before the third injection.
During the COVID-19 pandemic, 76% (35/46) of the physicians noticed that an increasing number of patients required medical advice about their MS and the consequences of an immunomodulatory therapy; 61% (28/46) noticed that patients increasingly avoided monitoring visits, delayed monitoring visits at the practice/hospital or asked for telehealth visits and 22% (10/46) noticed that patients with acute MS symptoms/relapses avoided visits or wanted to delay visits (Figure 4).
During the COVID-19 pandemic, some of the physicians made changes to the treatment for MS patients. Few physicians responded that in the majority of the cases, they postponed patient’s monitoring visits (4%; 2/46), postponed the infusion appointments (2%; 1/46) and initiated alternative therapies that patients could take at home (2%; 1/46).
During the COVID-19 pandemic, 98% (45/46) of physicians had no concerns about the use of interferon-β and glatiramer acetate; 61% (28/46) had no concerns about the use of dimethyl fumarate (DMF), teriflunomide, fingolimod and siponimod; and 17% (8/46) had no concerns about the use of cladribine, natalizumab, alemtuzumab and ocrelizumab.
During the COVID-19 pandemic, 50% of the treating physicians were of the opinion that a longer stay in the hospital/practice, such as during a DMT infusion or a clinical study visit, constitutes a risk. As high as 89% (41/46) of the treating physicians saw self-injecting MS therapy or taking it at home as an advantage over MS therapies administered as infusions.