SPOSAB ABP 501 - A SICILIAN PROSPECTIVE OBSERVATIONAL STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE TREATED WITH ADALIMUMAB BIOSIMILAR ABP 501

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S59-S59
Author(s):  
Fabio Salvatore Macaluso ◽  
Maria Cappello ◽  
Anita Busacca ◽  
Walter Fries ◽  
Anna Viola ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Observational Study ◽  
Bowel Disease ◽  
Prospective Observational Study ◽  
Treatment Persistence ◽  
Group A ◽  
Inflammatory Bowel ◽  
Abp 501 ◽  
Group B

Abstract Background and Aims There are few clinical data on Adalimumab (ADA) biosimilars in inflammatory bowel disease. Methods SPOSAB ABP 501 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease. All consecutive patients treated with ADA biosimilar ABP 501 from the introduction of the drug in Sicily (February 2019) to February 2020 (12 months) were enrolled to assess its safety and effectiveness. Patients were divided into 3 groups: group A, naïve to ADA and naïve to anti-TNFs; group B, naïve to ADA, previously exposed to anti-TNFs; group C: switched from ADA originator to ABP 501. Results 559 patients (median age 39 years; CD 88.0%, UC 12.0%) were included, with a follow-up time of 403.4 patient-years. Thirty-six SAEs occurred in 36 patients [(6.4% - incidence rate (IR): 8.9 per 100 person-years (PY)]. The IR of SAEs was higher among patients in group A compared with group C (17.4 vs. 4.8 per 100 PY; IR ratio=3.61; p<0.001) and among patients in group B compared with group C (16.4 vs. 4.8 per 100 PY; IR ratio=3.42; p=0.041). Among ADA-naïve patients (group A+B), 188 (85.8%) had a clinical response after 12 weeks, including 165 (75.3%) who achieved steroid-free remission. Higher treatment persistence estimates were reported for patients in group C compared with group A and B (log-rank p<0.001). Conclusions Safety and effectiveness of ABP 501 seem to be overall similar to those reported for ADA originator. Switching from originator to ABP 501 was safe and effective.

scholarly journals P436 SPOSAB ABP 501 - A Sicilian Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Adalimumab Biosimilar ABP 501

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S437-S438
Author(s):  
F Macaluso ◽  
M Cappello ◽  
A Busacca ◽  
W Fries ◽  
A Viola ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Incidence Rate ◽  
Bowel Disease ◽  
Rate Ratio ◽  
Incidence Rate Ratio ◽  
Group A ◽  
Inflammatory Bowel ◽  
Abp 501 ◽  
Group B

Abstract Background Clinical data on the use of Adalimumab (ADA) biosimilar ABP 501 in inflammatory bowel disease (IBD) are lacking. Methods SPOSAB ABP 501 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with Crohn’s Disease (CD) or Ulcerative Colitis (UC) treated with ABP 501 from the introduction of the drug in Sicily (February 2019) to February 2020 (12 months) were enrolled. Patients were divided into 3 groups (group A: naive to ADA and naive to anti-TNFs; group B: naive to ADA and previously exposed to anti-TNFs; group C: switch from ADA originator to ABP 501). The primary end-point was the assessment of safety, in terms of rate of serious adverse events (SAEs). Secondary end-point was the evaluation of effectiveness, in terms of clinical response and steroid-free clinical remission at 12 weeks for group A and B, and as treatment persistency for all 3 groups. Results 559 patients (median age 39 years; CD 88.0%, UC 12.0%) were included [group A: 189 (33.8%); group B: 30 (5.4%); group C: 340 (60.8]. Overall, the mean follow-up was 8.7 months (median 10.0 months, interquartile range: 6.0–12.0 months), and the total follow-up time was 403.4 patient-years. 36 SAEs occurred in 36 patients (6.4%), with an incidence rate of 8.9 per 100 person-years (PY), and 22 of them caused the withdrawal of the drug (incidence rate: 5.5 per 100 PY). The incidence rate of SAEs was higher among patients in group A compared with group C (17.4 vs. 4.8 per 100 PY; incidence rate ratio=3.61; p<0.001) and among patients in group B compared with group C (16.4 vs. 4.8 per 100 PY; incidence rate ratio=3.42; p=0.041). The effectiveness of ABP 501 after 12 weeks of treatment was assessed in patients naïve to ADA (group A + B; n=219): 188 patients (85.8%) had a clinical response, including 165 (75.3%) who achieved a steroid-free remission. Among the patients who responded at 12 weeks, a subsequent loss of response was reported in 17 subjects (9.0%). At the end of follow-up, 56 patients (10.0%) interrupted the treatment, with higher treatment persistency estimations for patients in group C compared with group A and B (log-rank p<0.001). Conclusion This is the first prospective study on the use of ADA biosimilar ABP 501 in IBD. Safety and effectiveness of ABP 501 seem to be overall similar to those reported for ADA originator. Switching from originator to ABP 501 was safe and effective.

SPOSAB ABP 501 - A SICILIAN PROSPECTIVE OBSERVATIONAL STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE TREATED WITH ADALIMUMAB BIOSIMILAR ABP 501

2021 ◽  
Vol 160 (3) ◽  
pp. S80
Author(s):  
Fabio Salvatore Macaluso ◽  
Maria Cappello ◽  
Anita Busacca ◽  
Walter Fries ◽  
Anna Viola ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Observational Study ◽  
Bowel Disease ◽  
Prospective Observational Study ◽  
Inflammatory Bowel ◽  
Abp 501

scholarly journals P425 SPOSIB SB2: a Sicilian prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar SB2

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S387-S388
Author(s):  
F S Macaluso ◽  
W Fries ◽  
A Viola ◽  
A Centritto ◽  
M Cappello ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Prospective Study ◽  
Incidence Rate ◽  
Bowel Disease ◽  
End Point ◽  
Group A ◽  
Inflammatory Bowel ◽  
Group B ◽  
Group D

Abstract Background Few data on Infliximab (IFX) biosimilar SB2 in inflammatory bowel disease (IBD) are available. Methods SPOSIB SB2 is a multicentre, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with Crohn’s disease (CD) or Ulcerative Colitis (UC) starting IFX biosimilar SB2 from the introduction of the drug in Sicily (March 2018) to September 2019 (18 months) were enrolled. Patients were divided into five groups (group A: naive to IFX, naive to anti-TNFs; group B: naive to IFX, previously exposed to other anti-TNFs; group C: switch from IFX originator to SB2; group D: switch from CT-P13 to SB2; group E: multiple switches: from IFX originator to CT-P13 to SB2). The primary end-point was the assessment of safety, in terms of the rate of serious adverse events (SAEs). Secondary end-point was the evaluation of effectiveness, in terms of steroid-free clinical remission and clinical response at 8 weeks and at the end of follow-up, and as treatment persistency. Results 276 patients (median age 39 years; CD 49.3%, UC 50.7%) were included [group A: 127 (46.0%); group B: 65 (23.6%); group C: 17 (6.2%); group D: 43 (15.6%); group E: 24 (8.7%)]. The cumulative number of infusions of SB2 was 1798, the median follow-up was 8 months (IQR: 4–12 months), and the total follow-up time was 182.7 patient-years (PY). Sixty-seven SAEs occurred in 57 patients (20.7%), with an incidence rate of 36.7 per 100 PY, and 26 of them caused the withdrawal of the drug. The incidence rate ratio (IRR) of SAEs was higher among patients in group B compared with group A (57.7 vs. 30.2 per 100 PY; IRr = 1.91; p = 0.026) and group C (57.7 vs. 18.9 per 100 PY; IRr = 2.93; p = 0.045). The effectiveness of IFX biosimilar SB2 after 8 weeks of treatment was evaluated in patients naïve to IFX (group A + B; n = 192): 110 patients (57.3%) had steroid-free remission, 26 patients (13.5%) achieved a partial response, while 56 patients had no response (29.2%). At the end of follow-up, 72 patients (26.1%) interrupted the treatment, without significant differences in treatment persistency estimations between the five groups (log-rank p = 0.15). Conclusion This is the first prospective study on the use of IFX biosimilar SB2 in IBD. Safety and efficacy of SB2 seem to be overall similar to those reported for IFX originator and IFX biosimilar CT-P13. A higher incidence of SAEs was observed among patients naive to IFX and previously exposed to other anti-TNFs.

Does Azathioprine induce endoscopic and histologic healing in pediatric inflammatory bowel disease? A prospective, observational study

2018 ◽  
Vol 50 (3) ◽  
pp. 240-246 ◽  
Author(s):  
Francesca Paola Giugliano ◽  
Caterina Strisciuglio ◽  
Massimo Martinelli ◽  
Marialuisa Andreozzi ◽  
Sabrina Cenni ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Observational Study ◽  
Bowel Disease ◽  
Prospective Observational Study ◽  
Pediatric Inflammatory Bowel Disease ◽  
Inflammatory Bowel

The SPOSIB SB2 Sicilian Cohort: Safety and Effectiveness of Infliximab Biosimilar SB2 in Inflammatory Bowel Diseases, Including Multiple Switches

2020 ◽  
Author(s):  
Fabio Salvatore Macaluso ◽  
Walter Fries ◽  
Anna Viola ◽  
Andrea Centritto ◽  
Maria Cappello ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Tumor Necrosis ◽  
Prospective Observational Study ◽  
Cumulative Number ◽  
Serious Adverse Events ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Necrosis Factor

Abstract Background No data on the recently introduced infliximab (IFX) biosimilar SB2 in inflammatory bowel disease (IBD) are available. Methods The Sicilian Prospective Observational Study of Patients With IBD Treated With Infliximab Biosimilar SB2 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease. All consecutive IBD patients starting the IFX biosimilar SB2 from its introduction in Sicily (March 2018) to September 2019 (18 months) were enrolled. Results Two hundred seventy-six patients (Crohn disease: 49.3%, ulcerative colitis: 50.7%) were included: 127 (46.0%) were naïve to IFX and naïve to anti-tumor necrosis factor medications (anti-TNFs), 65 (23.5%) were naïve to IFX and previously exposed to anti-TNFs, 17 (6.2%) were switched from an IFX originator to SB2, 43 (15.6%) were switched from the biosimilar CT-P13 to SB2, and 24 (8.7%) were multiply switched (from IFX originator to CT-P13 to SB2). The cumulative number of infusions of SB2 was 1798, and the total follow-up time was 182.7 patient-years. Sixty-seven serious adverse events occurred in 57 patients (20.7%; incidence rate: 36.7 per 100 patient-year), and 31 of these events caused the withdrawal of the drug. The effectiveness after 8 weeks of treatment was evaluated in patients naïve to IFX (n = 192): 110 patients (57.3%) had steroid-free remission, while 56 patients had no response (29.2%). At the end of follow-up, 72 patients (26.1%) interrupted the treatment, without significant differences in treatment persistency estimations between the five groups (log-rank P = 0.15). Conclusions The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13.

Sign in / Sign up

Export Citation Format

Share Document