1.Short-term Clinical Outcomes of Ranibizumab Biosimilar SB11 Therapy in Neovascular Age-related Macular Degeneration
Dong Gyu NA ; Chul Gu KIM ; Jong Woo KIM ; Jae Hui KIM
Journal of the Korean Ophthalmological Society 2025;66(5):224-232
Purpose:
To investigate the short-term outcomes of intravitreal injections of the ranibizumab biosimilar SB11 in patients with neovascular age-related macular degeneration (AMD).
Methods:
This retrospective comparative study assessed changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients diagnosed with neovascular AMD who received three monthly injections of SB11. The outcomes were compared to those of patients who received the same treatment using the ranibizumab originator. Within the SB11 group, comparisons were made between BCVA and CRT at diagnosis and after three injections. The proportion of patients with resolved subretinal fluid/intraretinal fluid was also evaluated.
Results:
The study included 46 eyes. In the SB11 group (n = 23), the average BCVA improved significantly from a baseline of logarithm of minimal angle of resolution 0.54 ± 0.42 to 0.40 ± 0.32 after three injections (p = 0.008). The average CRT decreased significantly from 447.4 ± 167.7 µm at baseline to 267.9 ± 66.9 µm after treatment (p < 0.001). Complete resolution of macular edema was observed in 19 eyes (82.7%). No significant differences were found in the degree of change in BCVA (p = 0.883) and CRT (p = 0.629) when compared to the ranibizumab originator group (n = 23). No complications such as intraocular inflammation or retinal detachment were noted.
Conclusions
Treatment with SB11 loading injections in neovascular AMD led to significant improvements in vision and reductions in macular thickness. The extent of improvement was comparable to that achieved with the ranibizumab originator and no severe complications were observed.
2.Concurrent Association of Multifocality, Bilaterality, and Recurrence in Pediatric Papillary Thyroid Cancer Patients
Jae Won CHO ; Cheong-Sil RAH ; Won Woong KIM ; Yu-mi LEE ; Seong Chul KIM ; Jung Hwan BAEK ; Dong Eun SONG ; Won Gu KIM ; Ki-Wook CHUNG ; Suck Joon HONG ; Tae-Yon SUNG
Yonsei Medical Journal 2025;66(1):43-50
Purpose:
Pediatric papillary thyroid cancer (PTC) is recommended to perform aggressive surgery to reduce the risk of recurrence.This study was designed to evaluate the concurrent association between multifocality, bilaterality, and the risk of recurrence in pediatric PTC.
Materials and Methods:
This retrospective cohort study included pediatric patients (age <19 years) who underwent total thyroidectomy for PTC between 1996 and 2014 in a single tertiary center. Clinicopathological parameters were analyzed to evaluate the prevalence of multifocality, bilaterality, recurrence, and their association.
Results:
We analyzed 58 pediatric patients with PTC. There was no factor related to the presence of multifocality or bilaterality in multivariate analysis. Also, in univariate analysis, multifocality and bilaterality were not independent risk factors of each other’s presentation (p=0.061 and p=0.061, respectively). Recurrence was observed in 19 (32.8%) patients. In multivariate analysis of recurrence, clear cell subtype, multifocality, and gross extrathyroidal extension (ETE) were independent risk factors (p=0.027, p=0.035, and p=0.038, respectively). Most recurrences (68.4%) happened during the first 4 years of follow-up after the initial thyroidectomy.
Conclusion
Multifocality and bilaterality were not independent risk factors of each other’s presentation; however, multifocality was the risk factor for recurrence in pediatric PTC. For pediatric PTC, close monitoring for recurrence within the initial 4 years is recommended, particularly in patients with clear cell subtype, multifocality, and gross ETE.
3.Concurrent Association of Multifocality, Bilaterality, and Recurrence in Pediatric Papillary Thyroid Cancer Patients
Jae Won CHO ; Cheong-Sil RAH ; Won Woong KIM ; Yu-mi LEE ; Seong Chul KIM ; Jung Hwan BAEK ; Dong Eun SONG ; Won Gu KIM ; Ki-Wook CHUNG ; Suck Joon HONG ; Tae-Yon SUNG
Yonsei Medical Journal 2025;66(1):43-50
Purpose:
Pediatric papillary thyroid cancer (PTC) is recommended to perform aggressive surgery to reduce the risk of recurrence.This study was designed to evaluate the concurrent association between multifocality, bilaterality, and the risk of recurrence in pediatric PTC.
Materials and Methods:
This retrospective cohort study included pediatric patients (age <19 years) who underwent total thyroidectomy for PTC between 1996 and 2014 in a single tertiary center. Clinicopathological parameters were analyzed to evaluate the prevalence of multifocality, bilaterality, recurrence, and their association.
Results:
We analyzed 58 pediatric patients with PTC. There was no factor related to the presence of multifocality or bilaterality in multivariate analysis. Also, in univariate analysis, multifocality and bilaterality were not independent risk factors of each other’s presentation (p=0.061 and p=0.061, respectively). Recurrence was observed in 19 (32.8%) patients. In multivariate analysis of recurrence, clear cell subtype, multifocality, and gross extrathyroidal extension (ETE) were independent risk factors (p=0.027, p=0.035, and p=0.038, respectively). Most recurrences (68.4%) happened during the first 4 years of follow-up after the initial thyroidectomy.
Conclusion
Multifocality and bilaterality were not independent risk factors of each other’s presentation; however, multifocality was the risk factor for recurrence in pediatric PTC. For pediatric PTC, close monitoring for recurrence within the initial 4 years is recommended, particularly in patients with clear cell subtype, multifocality, and gross ETE.
4.Concurrent Association of Multifocality, Bilaterality, and Recurrence in Pediatric Papillary Thyroid Cancer Patients
Jae Won CHO ; Cheong-Sil RAH ; Won Woong KIM ; Yu-mi LEE ; Seong Chul KIM ; Jung Hwan BAEK ; Dong Eun SONG ; Won Gu KIM ; Ki-Wook CHUNG ; Suck Joon HONG ; Tae-Yon SUNG
Yonsei Medical Journal 2025;66(1):43-50
Purpose:
Pediatric papillary thyroid cancer (PTC) is recommended to perform aggressive surgery to reduce the risk of recurrence.This study was designed to evaluate the concurrent association between multifocality, bilaterality, and the risk of recurrence in pediatric PTC.
Materials and Methods:
This retrospective cohort study included pediatric patients (age <19 years) who underwent total thyroidectomy for PTC between 1996 and 2014 in a single tertiary center. Clinicopathological parameters were analyzed to evaluate the prevalence of multifocality, bilaterality, recurrence, and their association.
Results:
We analyzed 58 pediatric patients with PTC. There was no factor related to the presence of multifocality or bilaterality in multivariate analysis. Also, in univariate analysis, multifocality and bilaterality were not independent risk factors of each other’s presentation (p=0.061 and p=0.061, respectively). Recurrence was observed in 19 (32.8%) patients. In multivariate analysis of recurrence, clear cell subtype, multifocality, and gross extrathyroidal extension (ETE) were independent risk factors (p=0.027, p=0.035, and p=0.038, respectively). Most recurrences (68.4%) happened during the first 4 years of follow-up after the initial thyroidectomy.
Conclusion
Multifocality and bilaterality were not independent risk factors of each other’s presentation; however, multifocality was the risk factor for recurrence in pediatric PTC. For pediatric PTC, close monitoring for recurrence within the initial 4 years is recommended, particularly in patients with clear cell subtype, multifocality, and gross ETE.
5.Short-term Clinical Outcomes of Ranibizumab Biosimilar SB11 Therapy in Neovascular Age-related Macular Degeneration
Dong Gyu NA ; Chul Gu KIM ; Jong Woo KIM ; Jae Hui KIM
Journal of the Korean Ophthalmological Society 2025;66(5):224-232
Purpose:
To investigate the short-term outcomes of intravitreal injections of the ranibizumab biosimilar SB11 in patients with neovascular age-related macular degeneration (AMD).
Methods:
This retrospective comparative study assessed changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients diagnosed with neovascular AMD who received three monthly injections of SB11. The outcomes were compared to those of patients who received the same treatment using the ranibizumab originator. Within the SB11 group, comparisons were made between BCVA and CRT at diagnosis and after three injections. The proportion of patients with resolved subretinal fluid/intraretinal fluid was also evaluated.
Results:
The study included 46 eyes. In the SB11 group (n = 23), the average BCVA improved significantly from a baseline of logarithm of minimal angle of resolution 0.54 ± 0.42 to 0.40 ± 0.32 after three injections (p = 0.008). The average CRT decreased significantly from 447.4 ± 167.7 µm at baseline to 267.9 ± 66.9 µm after treatment (p < 0.001). Complete resolution of macular edema was observed in 19 eyes (82.7%). No significant differences were found in the degree of change in BCVA (p = 0.883) and CRT (p = 0.629) when compared to the ranibizumab originator group (n = 23). No complications such as intraocular inflammation or retinal detachment were noted.
Conclusions
Treatment with SB11 loading injections in neovascular AMD led to significant improvements in vision and reductions in macular thickness. The extent of improvement was comparable to that achieved with the ranibizumab originator and no severe complications were observed.
6.Concurrent Association of Multifocality, Bilaterality, and Recurrence in Pediatric Papillary Thyroid Cancer Patients
Jae Won CHO ; Cheong-Sil RAH ; Won Woong KIM ; Yu-mi LEE ; Seong Chul KIM ; Jung Hwan BAEK ; Dong Eun SONG ; Won Gu KIM ; Ki-Wook CHUNG ; Suck Joon HONG ; Tae-Yon SUNG
Yonsei Medical Journal 2025;66(1):43-50
Purpose:
Pediatric papillary thyroid cancer (PTC) is recommended to perform aggressive surgery to reduce the risk of recurrence.This study was designed to evaluate the concurrent association between multifocality, bilaterality, and the risk of recurrence in pediatric PTC.
Materials and Methods:
This retrospective cohort study included pediatric patients (age <19 years) who underwent total thyroidectomy for PTC between 1996 and 2014 in a single tertiary center. Clinicopathological parameters were analyzed to evaluate the prevalence of multifocality, bilaterality, recurrence, and their association.
Results:
We analyzed 58 pediatric patients with PTC. There was no factor related to the presence of multifocality or bilaterality in multivariate analysis. Also, in univariate analysis, multifocality and bilaterality were not independent risk factors of each other’s presentation (p=0.061 and p=0.061, respectively). Recurrence was observed in 19 (32.8%) patients. In multivariate analysis of recurrence, clear cell subtype, multifocality, and gross extrathyroidal extension (ETE) were independent risk factors (p=0.027, p=0.035, and p=0.038, respectively). Most recurrences (68.4%) happened during the first 4 years of follow-up after the initial thyroidectomy.
Conclusion
Multifocality and bilaterality were not independent risk factors of each other’s presentation; however, multifocality was the risk factor for recurrence in pediatric PTC. For pediatric PTC, close monitoring for recurrence within the initial 4 years is recommended, particularly in patients with clear cell subtype, multifocality, and gross ETE.
7.Short-term Clinical Outcomes of Ranibizumab Biosimilar SB11 Therapy in Neovascular Age-related Macular Degeneration
Dong Gyu NA ; Chul Gu KIM ; Jong Woo KIM ; Jae Hui KIM
Journal of the Korean Ophthalmological Society 2025;66(5):224-232
Purpose:
To investigate the short-term outcomes of intravitreal injections of the ranibizumab biosimilar SB11 in patients with neovascular age-related macular degeneration (AMD).
Methods:
This retrospective comparative study assessed changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients diagnosed with neovascular AMD who received three monthly injections of SB11. The outcomes were compared to those of patients who received the same treatment using the ranibizumab originator. Within the SB11 group, comparisons were made between BCVA and CRT at diagnosis and after three injections. The proportion of patients with resolved subretinal fluid/intraretinal fluid was also evaluated.
Results:
The study included 46 eyes. In the SB11 group (n = 23), the average BCVA improved significantly from a baseline of logarithm of minimal angle of resolution 0.54 ± 0.42 to 0.40 ± 0.32 after three injections (p = 0.008). The average CRT decreased significantly from 447.4 ± 167.7 µm at baseline to 267.9 ± 66.9 µm after treatment (p < 0.001). Complete resolution of macular edema was observed in 19 eyes (82.7%). No significant differences were found in the degree of change in BCVA (p = 0.883) and CRT (p = 0.629) when compared to the ranibizumab originator group (n = 23). No complications such as intraocular inflammation or retinal detachment were noted.
Conclusions
Treatment with SB11 loading injections in neovascular AMD led to significant improvements in vision and reductions in macular thickness. The extent of improvement was comparable to that achieved with the ranibizumab originator and no severe complications were observed.
8.Concurrent Association of Multifocality, Bilaterality, and Recurrence in Pediatric Papillary Thyroid Cancer Patients
Jae Won CHO ; Cheong-Sil RAH ; Won Woong KIM ; Yu-mi LEE ; Seong Chul KIM ; Jung Hwan BAEK ; Dong Eun SONG ; Won Gu KIM ; Ki-Wook CHUNG ; Suck Joon HONG ; Tae-Yon SUNG
Yonsei Medical Journal 2025;66(1):43-50
Purpose:
Pediatric papillary thyroid cancer (PTC) is recommended to perform aggressive surgery to reduce the risk of recurrence.This study was designed to evaluate the concurrent association between multifocality, bilaterality, and the risk of recurrence in pediatric PTC.
Materials and Methods:
This retrospective cohort study included pediatric patients (age <19 years) who underwent total thyroidectomy for PTC between 1996 and 2014 in a single tertiary center. Clinicopathological parameters were analyzed to evaluate the prevalence of multifocality, bilaterality, recurrence, and their association.
Results:
We analyzed 58 pediatric patients with PTC. There was no factor related to the presence of multifocality or bilaterality in multivariate analysis. Also, in univariate analysis, multifocality and bilaterality were not independent risk factors of each other’s presentation (p=0.061 and p=0.061, respectively). Recurrence was observed in 19 (32.8%) patients. In multivariate analysis of recurrence, clear cell subtype, multifocality, and gross extrathyroidal extension (ETE) were independent risk factors (p=0.027, p=0.035, and p=0.038, respectively). Most recurrences (68.4%) happened during the first 4 years of follow-up after the initial thyroidectomy.
Conclusion
Multifocality and bilaterality were not independent risk factors of each other’s presentation; however, multifocality was the risk factor for recurrence in pediatric PTC. For pediatric PTC, close monitoring for recurrence within the initial 4 years is recommended, particularly in patients with clear cell subtype, multifocality, and gross ETE.
9.Effects of surgical factors on the outcomes of zygoma reduction malarplasty: a quantitative computed tomography study
Maxillofacial Plastic and Reconstructive Surgery 2023;45(1):3-
Background:
Malarplasty is widely performed for zygoma reduction. The effects of body segmentation, plate bending, and postoperative arch location on zygomatic movement have not been analyzed using computed tomography (CT).
Results:
We quantitatively analyzed the effects of surgical factors on zygomatic movements via superimposition of preoperative and postoperative CT images using three-dimensional software. Our results showed that segmentation had the most significant effect on the horizontal reduction of malar eminence (β = 0.593, r = 0.696, adjusted r2 0.479, F = 79.595; p < 0.001). In addition, upward and posterior arch movements had significant effects on the anteriorand posterior movements of the eminence (β = − 0.379 for vertical arch movement, β = 0.324 for arch setback, r = 0.603, adjusted r2 = 0.352, F = 31.943; p < 0.001). The major factors that influenced inward arch movement at thecoronoid process included segmentation and inward movement at the arch osteotomy site. To prevent interference of the coronoid process and arch, surgeons should pay attention to the degree of segmentation (β = 0.349) and inward movement at the arch osteotomy site (β = 0.494; r = 0.688, adjusted r2 = 0.464, F = 50.412; p < 0.001).
Conclusions
Surgical factors related to malarplasty affect the movement of specific parts of the zygoma. In addition, accurate application is possible by considering the anatomical structure of the application area when using the bending plate.
10.Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
Seo-Yeon AHN ; Sang Kyun SON ; Gyu Hyung LEE ; Inho KIM ; June-Won CHEONG ; Won Sik LEE ; Byung Soo KIM ; Deog-Yeon JO ; Chul Won JUNG ; Chu Myoung SEONG ; Jae Hoon LEE ; Young Jin YUH ; Min Kyoung KIM ; Hun-Mo RYOO ; Moo-Rim PARK ; Su-Hee CHO ; Hoon-Gu KIM ; Dae Young ZANG ; Jinny PARK ; Hawk KIM ; Seryeon LEE ; Sung-Hyun KIM ; Myung Hee CHANG ; Ho Sup LEE ; Chul Won CHOI ; Jihyun KWON ; Sung-Nam LIM ; Suk-Joong OH ; Inkyung JOO ; Dong-Wook KIM
Blood Research 2022;57(2):144-151
Background:
Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea.
Methods:
An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response.
Results:
During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients).
Conclusion
This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.

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