Correction to: Ophthalmol Ther 10.1007/s40123-020-00280-8
The authors of the above mentioned article would like to highlight the following corrections, based upon recent changes to the FDA label and guidance on the use of belamaf.
Page 3: The second sentence under “Methods” should be “In brief, eligible patients with RRMM were randomized (1:1) to receive belamaf 2.5- or 3.4-mg/kg every 3 weeks by intravenous infusion over 30 min or longer on day 1 of each cycle.”
Page 5: Table 1, Grade 4, Recommended dose modification currently reads “Permanently discontinue treatment”. This should be “Consider treatment discontinuation for a Grade 4 event. Based on a benefit:risk assessment, if continuing treatment with belamaf is being considered, treatment may be resumed at a reduced dose after the event has improved to Grade 1 or better event.”
Page 6: Table 2, BCVA change, event outcomes as of last follow-up reads “26/44 (48).” This should be “26/44 (59)”. Subjective dry eye, first event outcomes reads “2/14 (31).” This should be “2/14 (14)”. Blurred vision, event outcome as of last follow-up, not recovered reads “9/24 (37).” This should be “9/24 (38)”.
Page 8, 2nd column, 1st paragraph reads “28% (25/95) of patients” this should read “28% (25/88) of patients”.
Page 9, 2nd column, first paragraph reads “Cogan microscysts”. This should be “microcysts”.
Page 10: Fig. 4 legend, reads “In vivo confocal microscopic image from the same patient (d–f) demonstrating hyperreflective opacities within the corneal epithelium.” This should be “(c–f)”.
Page 10, 2nd column, first paragraph, first sentence reads: “Following the first dose of belamaf 2.5 mg/kg, he presented on day 27 with MECs characterized as mild/patchy in the periphery/mid-periphery on slit lamp microscopy (Fig. 5a, b). IVCM of the involved areas revealed hyperreflective opacities (Fig. 5c).” This should read as “(Fig. 4a, b)” and “(Fig. 4c–f)”, respectively.
Page 18: Under “Recommended Monitoring, Diagnosis, and Management Techniques” and “Diagnosis and Staging of MECs” the final sentence currently reads “The eye care professional should also determine if the decline in BCVA is related to belamaf-associated examination finding(s).” This should be “Determine the recommended dosage modification of belamaf based on the worst finding in the worst affected eye. Worst finding should be based on either a corneal examination finding or a change in visual acuity per the KVA scale.”
Page 18: Under “Recommended Monitoring, Diagnosis, and Management Techniques” and “Management” the sentence currently reads “Treatment should be permanently discontinued for a grade 4 event.” This should be “Consider treatment discontinuation for a grade 4 event. Based on a benefit:risk assessment, if continuing treatment with belamaf is being considered, treatment may be resumed at a reduced dose after the event has improved to grade 1 or better event.”
The original article has been corrected.
Table 1.
Recommended belamaf dose modifications based on eye examination findings per the KVA scale
| Eye examination findings per KVA scale | Recommended dose modifications | |
|---|---|---|
| Grade 1 | Corneal examination finding(s) | Continue treatment at current dose |
| Mild superficial keratopathya | ||
| Change in BCVAb | ||
| Decline from baseline of 1 line on Snellen Visual Acuity | ||
| Grade 2 | Corneal examination finding(s) | Withhold treatment until improvement in both corneal examination findings and changes in BCVA to Grade 1 or better and resume at same dose |
| Moderate superficial keratopathyc | ||
| Change in BCVAb | ||
| Decline from baseline of 2 or 3 lines (and Snellen Visual Acuity not worse than 20/200) | ||
| Grade 3 | Corneal examination finding(s) | Withhold treatment until improvement in both corneal examination findings and changes in BCVA to Grade 1 or better and resume at a reduced dose |
| Severe superficial keratopathyd | ||
| Change in BCVAb | ||
| Decline from baseline by more than 3 lines (and Snellen Visual Acuity not worse than 20/200) | ||
| Grade 4 | Corneal examination finding(s) | Consider treatment discontinuation for a Grade 4 event. Based on a benefit:risk assessment, if continuing treatment with belamaf is being considered, treatment may be resumed at a reduced dose after the event has improved to Grade 1 or better event |
| Corneal epithelial defecte | ||
| Change in BCVAb | ||
| Snellen Visual Acuity worse than 20/200 | ||
BCVA best-corrected visual acuity, KVA keratopathy and visual acuity, MEC microcystic-like epithelial change
DREAMM-2 utilized a pre-specified scale, the KVA scale, that combined slit lamp examination findings (e.g., keratopathy/MECs) with an assessment of BCVA using Snellen Chart
aMild superficial keratopathy (documented worsening from baseline), with or without symptoms
bChanges in visual acuity due to treatment-related corneal findings
cModerate superficial keratopathy with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity
dSevere superficial keratopathy with or without diffuse microcyst-like deposits involving the central cornea, sub-epithelial haze (central), or a new central stromal opacity
eCorneal epithelial defect such as corneal ulcers