Patient-Reported Experiences on Adalimumab Biosimilar SB5 and Correlation With Treatment Persistence

The PERFUSE study evaluated patient training, satisfaction, and persistence with treatment of inflammatory bowel disease (IBD) with the biosimilar adalimumab SB5 across multiple sites in France. Overall, the study reported a high degree of satisfaction, however there were significant differences in survey response rates and provision of training across sites. The authors said their findings suggested a lack of support during switches.

According to the authors, the introduction of biologics, such as the tumor necrosis factor (TNF)-α inhibitor adalimumab, as a treatment for IBD (Crohn disease and ulcerative colitis), though expensive, has enabled more patients to achieve long-term remission.

They used patient-reported outcome measures (PROMs) to study patient training on the injection device and satisfaction with treatment, and their impact on 12-month persistence on SB5 therapy for IBD. They noted that in France, “specific training is recommended for all new users of an injection device.”

The observational study included 318 patients with Crohn disease and 88 with ulcerative colitis who received adalimumab SB5 across 27 sites in France. Of these 406 patients, 254 had not previously received biologic therapy, and 152 had. The investigators collected clinical data from patient visits and patient-reported data from an online questionnaire given 1 month after baseline. The investigators then assessed how patient-reported results correlated with SB5 treatment persistence at 12 months.

Training was offered more often to biologic-naïve compared to pretreated patients

Approximately half of the patients responded to the questionnaire, 57% biologic-naïve patients and 44% of pretreated patients. Persistence on SB5 treatment was significantly higher in patients who responded to the questionnaire compared to those who did not (68% vs 52%). Most of the biologic-naïve patients (87%) and about one-third (31%) of pretreated patients reported they were offered training on the proper use of the injection device. Almost all naïve patients offered training (97%) and 62% of pretreated patients offered training attended the training session. For both naïve and pretreated patients, the percentage of patients offered training varied by site. On average, sites offered training to 77% of naïve patients and 15% of pretreated patients.

Satisfaction with the injection device was higher in biologic-naïve and trained patients

Patient satisfaction with the information they received on biosimilars was similar in naïve and pretreated patients, rated on a scale of 0 (worst) to 10 (best). Naïve patients rated their satisfaction with the information 8.2 out of 10 (SD,, 2.0) and pretreated patients 8.7 (SD,, 1.6). Satisfaction with their overall care at the time of prescription was rated 8.1 in both groups (SD,, 1.7 and 1.4). The 2 groups also similarly rated their confidence using the injection device, 8.6 (SD, 2.2) and 8.7 (SD, 2.6); however, satisfaction with the injection device was significantly higher in naïve patients, 8.2 (SD, 1.9) vs 6.8 (SD, 2.8). Patients who reported better satisfaction with the injection device were not significantly less likely to stop SB5 treatment within 12 months than those with lower scores (odd’s ratio [OR], 0.91, 95% CI 0.83-1.01).

Overall, between patients who attended or did not attend a training session, there were no significant differences in their ratings of confidence using the injection device, 8.6 (SD, 2.1) and 8.5 (SD, 2.7). However, satisfaction with the injection device was rated higher overall by patients who attended a training session, 8.2 (SD, 1.8) compared to 7.0 (SD, 2.8). Satisfaction with the injection device was rated higher by patients who attended a training session within the naïve population, 8.2 (SD, 1.8) vs 7.0 (SD, 2.8), but not those in the pretreated population, 7.0 (SD, 1.5) vs 6.7 (SD, 2.9). Treatment persistence at 12 months was not significantly lower in patients who attended a training session (63%) compared to those who did not (75.1%).

There was no significant difference in ratings of patient-physician communication between biologic-naïve and pretreated patients, or between patients who attended and did not attend a training session. On average, ratings ranged from 41.2 to 43.5 on a scale of 0 to 50.

Patients completed the Beliefs about Medicines Questionnaire (BMQ), used to evaluate beliefs and fears about their treatment and illness. According to the authors, the scores of both naïve and pretreated patients on the BMQ indicated that “patients’ concerns about their treatment outweighed the perceived necessity to treat their illness.” However, there were no correlations between BMQ scores and SB5 treatment persistence at 12 months.

Patients with a more positive outlook on their illness significantly less likely to stop treatment

The investigators used the Brief Illness Perception Questionnaire (B-IPQ) to evaluate patients’ perception of their illness, with a higher score indicating a more positive perception. Although the scores were significantly higher in naïve patients, scores in both naïve and pretreated patients were “moderate, showing that most patients were generally ambivalent regarding their disease.” However, patients with higher B-IPQ scores, indicating a more positive perception of their illness, were significantly more likely to stop treatment within 12 months than those with lower scores (OR, 1.02; 95% CI, 1.00-1.05).

The authors concluded their study showed “a high degree of satisfaction and confidence” in SB5 treatment for IBD in both biologic-naïve and pretreated patients. However, pretreated patients were offered training less often and were less likely to attend training. They said these findings suggest “a lack of support during switches.” Since in France, it is recommended that all patients be “adequately informed on any newly prescribed treatment,” the authors say their findings suggest “application of these recommendations must be improved, especially when switching.”

The investigators also noted “strong disparities” between the different sites in offering training, which they said, “highlights the need to provide additional support to sites lacking the necessary resources to provide these services consistently.” Finally, they said “early online patient questionnaires may help identify patients at a higher risk of non-persistence who may require closer follow-up.”

They acknowledged their study was limited by the lack of data on experiences and adverse events during pretreated patients’ previous treatment, a low questionnaire response rate, large variation in response rates between sites, and because reasons for treatment discontinuation were outside the scope of their analysis.

Reference

Bouhnik Y, Carbonnel F, Fumery M, Flamant M, Buisson A, Camoin A, Addison J. The PERFUSE study: The experience of patients receiving adalimumab biosimilar SB5. Dig Liver Dis. 2023;55(12):1658-1666. doi:10.1016/j.dld.2023.05.025