麻豆传媒

Reduced treatment burden for neovascular age-related macular degeneration met with overwhelming approval in an analysis of patient-reported outcomes (PROs) from a randomized trial.

After 40 weeks of follow-up, about two-thirds of patients expressed satisfaction with anti-VEGF therapy, regardless of whether they had the ranibizumab port delivery system (PDS; Susvimo) or received monthly injections of ranibizumab (Lucentis). However, 93.2% of patients in the PDS arm preferred the ocular implant versus 1.3% who preferred the intravitreal injections they received prior to the implant.

Overall, both methods of treatment administration had high patient satisfaction ratings, reported Gene Wallenstein, PhD, of Genentech, which supported the study, and co-authors in .

"We found that continuous delivery of ranibizumab via the PDS was preferred by almost all patients in the PDS group vs intravitreal injections," the authors wrote in conclusion. "Preference for the PDS was supported by findings in patients with bilateral [neovascular age-related macular degeneration] who received concurrent intravitreal injections in the fellow eye. Most patients who experienced ocular SAEs [serious adverse events] preferred treatment with PDS."

"The overall results appear to be driven by the perceived reductions in treatment burden reported as the need for fewer treatments, requiring less time for treatment, and less discomfort," they noted.

Assessing patient satisfaction is challenging outside the setting of a crossover clinical trial, though the exploratory analysis of PROs from a randomized trial addressed the challenge to some extent because all patients assigned to the PDS had received prior anti-VEGF therapy via intravitreal injections, pointed out Wesley T. Beaulieu, PhD, and Adam R. Glassman, MS, of the Jaeb Center for Health Research in Tampa, Florida, in an .

"However, unlike a crossover study, preference for treatment with in-office injections and PDS treatment cannot be evaluated equally in this study because there might be other factors unrelated to treatment impacting a patient preference," they wrote. "For example, prestudy anti-vascular endothelial growth factor injections were given as part of usual care and presumably paid for by the study participants, whereas PDS treatment was given in a clinical trial setting and likely covered by the sponsor."

"How will patients and clinicians decide on a treatment strategy given the similar efficacy profiles but different injection burdens in favor of the PDS and safety profiles in favor of in-office injections as frequently as monthly?" Beaulieu and Glassman asked. "Longer-term follow-up and more granular analyses, especially among those experiencing treatment-related adverse events, are needed."

The PRO data came from a planned exploratory analysis of the phase III randomized ARCHWAY trial comparing the PDS and conventional monthly injections of ranibizumab. The PDS is a continuous-release device, designed to be refilled with ranibizumab once every 6 months. The trial met the primary endpoint of noninferiority, demonstrating similar vision outcomes with the two approaches to administering anti-VEGF therapy.

All 418 patients enrolled in the trial had documented response to at least two intravitreal injections of ranibizumab prior to randomization (3:2). The patients had a mean age of 75, and 59% were women. The exploratory analysis of patient satisfaction included 234 patients.

Investigators assessed overall treatment satisfaction in both arms of the trial by means of the (MacTSQ). Patient preference for the PDS or intravitreal injections was assessed by means of the content-validated (PPPQ). The primary outcomes of the analysis were satisfaction with randomized treatment at 40 weeks and patient preference for the PDS versus intravitreal injection in the patients randomized to the PDS, also at 40 weeks.

Overall satisfaction with treatment did not differ significantly between the treatment groups, as patients assigned to the PDS had a mean MacTSQ score of 68 as compared with 66 for patients randomized to monthly intravitreal injections. The PPPQ results showed that almost all the patients in the PDS arm preferred the ocular implant over monthly injections, including 73.5% of patients who had a "very strong preference" for the device. Among 72 patients who had the PDS in one eye and received one or more concurrent intravitreal injections in the opposite eye, 92.3% preferred the PDS.

The PDS was associated with more ocular SAEs as compared with monthly intravitreal injections. Among 12 patients with ocular SAEs in the PDS arm, nine (75%) expressed a preference for the ocular implant, as compared with 94.1% of patients who did not have an ocular SAE.

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