Twelve-Month Outcomes of Faricimab for Patients With Sub-optimally Responsive Diabetic Macular Oedema in a UK Tertiary Referral Centre

Abstract

Purpose Evaluating 12-month visual and anatomical outcomes after switching to faricimab in diabetic macular oedema (DMO) patients with sub-optimal response to aflibercept 2mg.

Patients and methods Sixty-two eyes of fifty patients were enrolled in this retrospective study at a UK tertiary referral centre. This consisted of DMO patients with sub-optimal response to aflibercept 2mg who were switched to faricimab. Four loading injections of faricimab were given at monthly intervals, followed by a treat-and-extend regime. The sub-optimal response was defined as CST >325 microns or >20% from best CST despite aflibercept 2mg at less than or equal to 8 weekly intervals(≤q8w) having completed a loading dose of aflibercept 2 mg (6 injections at monthly intervals). Outcome measures were best-recorded visual acuity (BRVA), central subfield thickness (CST), and treatment intervals.

Results Baseline BRVA was 67.6 (±11.8) letters and CST was 406.4 (±105.9) µm, and the mean treatment interval was 6.5 (±1.8) weeks. At baseline, 24.2% of eyes were treated every 4 weeks (q4w), 19.4% every 6 weeks (q6w), and 56.5% every 8 weeks (q8w). After the 4th faricimab loading dose, 54 patients continued on treat-and-extend faricimab. BRVA improved to 70.4 (±12.7) letters (p=0.007) while CST reduced to 372.8 (±132.0)µm (p=0.070). The mean injection interval improved to 7.4 (±2.6), 95%CI[0.1, 2.9]weeks. Subjects were followed up for 57.1 (±19.7) weeks, with a mean of 7.92 (±2.53) faricimab injections. At the latest follow-up, BRVA was stable at 68.7 (±14.6)(p=0.918) letters. CST had reduced further to 343.1 (±117.5) µm(p=0.034). Treatment intervals at the latest follow-up were: 3.2% q4w, 9.7% q6w, 30.6% q8w, 3.2% q10w, 11.3% q12w, 1.6% q14w, 6.5% q16w, with 53.2% on ≥q8w. The mean injection interval had also improved to 9.2 (±3.1) weeks(p=0.122).

Conclusion In this study, DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision by switching to faricimab.

Competing Interest Statement

Kamal El-Badawi: No conflicts of interest to declare. Benjamin Scrivens: Educational grant from Roche. Oluwaniyi Eke: Travel bursary and advisory board Bayer, speaker fees Roche. Rehab Ismail: No conflicts of interest to declare. Serena Salvatore: Advisory board for Bayer, Roche; Speaker fees and travel bursary from Alimera Sciences, Roche Products Limited, Bayer. Lina Kobayter: Advisory board and travel bursary from Roche Products Limited.. Speaker fees from Bayer, Alimera Sciences and Roche Products Limited.

Funding Statement

Funding was not received for completion of this study. The authors of this study have requested funding from Roche to cover submission costs. No confirmed funding at the point of this submission

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Medisoft database. The Deputy Medical Director and Caldicott Guardian of NHS University Hospitals Briston and Weston - NHS Foundation Trust provided approval for the use of the de-identified data in this study.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

All data produced in the present study are available upon reasonable request to the authors

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