Ranibizumab in Diabetic Macular Oedema – A Benefit–risk Analysis of Ranibizumab 0.5 mg PRN Versus Laser Treatment

Abstract

Introduction: The structured Benefit–risk Action Team (BRAT) approach aims to assist healthcare decision makers in treatment assessments. We applied BRAT to compare the benefit–risk profile of ranibizumab 0.5 mg versus laser photocoagulation for the treatment of diabetic macular oedema (DMO). Methods: One-year data for the ranibizumab 0.5 mg pro re nata (PRN) and laser arms of the phase III trials RESPOND (NCT01135914; n=220), RESTORE (NCT00687804; n=345), and REVEAL (NCT00989989; n=396) were included in the analysis. The benefit measures included ≥10 letters gain/avoidance of loss in best-corrected visual acuity (BCVA), achieving central retinal thickness (CRT) <275 μm, and 25-item Visual Function Questionnaire (VFQ-25) outcomes. The risks measures included endophthalmitis, intraocular pressure increase, hypertension, proteinuria, arterial/venous thromboembolic events and deaths. Results: Ranibizumab treatment provided significant benefits compared with laser for ≥10 letter BCVA gain at month 12 (387/1,000 versus 152/1,000 patients), CRT <275 μm at 12 months (474/1,000 versus 348/1,000 patients), and improvement of ≥6.06 on the VFQ-25 near activities subscale (325/1,000 versus 245/1,000 patients). Results for the risk measures were similar for both treatments. Conclusions: Superior clinically relevant outcomes were observed with ranibizumab 0.5 mg PRN compared with laser without compromising on safety. This analysis further supports the positive benefit–risk profile of ranibizumab 0.5 mg PRN.

Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression

“…The BRAT framework is a broadly accepted approach for benefit–risk assessment 7,8,24–26 . It is a process to facilitate the selection, organization, summarization, and communication of evidence for benefit–risk decision making.…”

“…The BRAT framework is a broadly accepted approach for benefit-risk assessment. 7,8,[24][25][26] It is a process to facilitate the selection, organization, summarization, and communication of evidence for benefit-risk decision making. The BRAT framework comprises the following steps: (i) define the decision context, (ii) identify efficacy and safety outcomes that have an important effect on the benefit-risk balance, (iii) identify source data, (iv) customize the framework, (v) assess outcome importance, and (vi) display and interpret the key benefit-risk metrics (Table S1).…”

Stellungnahme der DOG, der RG und des BVA zur Therapie des diabetischen Makulaödems

“…Für die Bewertung der Wirksamkeit gibt es Hinweise, dass eine IVOM-Behandlung mit VEGF-Inhibitoren (Aflibercept [157], Bevacizumab [158], Ranibizumab [15,159,160]) zumindest über Zeiträume von wenigen Jahren der alleinigen fokalen Lasertherapie bei einem Makulaödem mit Foveabeteiligung und Visusminderung überlegen ist. Ansonsten gibt esbis auf wenige Ausnahmen (Kombinationstherapie [39], Vergleich mit Triamcinolon [161])kaum Daten zum direkten Vergleich zwischen den Wirkstoffgruppen.…”

“…Die fokale Laserkoagulation stellt aktuell eine Reservetherapie für das DMÖ mit fovealer Beteiligung dar [160,243]. Dennoch gibt es Situationen, in denen eine intravitreale Therapie nicht verabreicht werden kann/darf, abgelehnt wird oder bewusst eine Entscheidung zur Lasertherapie getroffen wird.…”