Comparison of Performances of Adalimumab Biosimilars SB5, APB501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

Background Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce. We compare the efficacy and safety of ADA biosimilars SB5, APB501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. Methods A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. Results A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. Conclusions Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.Lay Summary We treated 533 IBD patients with adalimumab (ADA) biosimilars SB5, APB501, GP2017, and MSB11022. No differences between these 4 ADA biosimilars were found for reaching remission in naive patients, maintaining remission for nonmedical switching, clinical response, steroid-free remission, surgery rate, mucosal healing, or safety

Replacement of Adalimumab Originator to Adalimumab Biosimilar for a Non-Medical Reason in Patients with Inflammatory Bowel Disease: A Real-life Comparison of Adalimumab Biosimilars Currently Available in Italy

Background and aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason. Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars. Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild. Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed

The "DICA" endoscopic classification for diverticular disease of the colon shows a significant interobserver agreement among community endoscopists

BACKGROUND AND AIM: An endoscopic classification of Diverticular Disease (DD), called DICA (Diverticular Inflammation and Complication Assessment) is currently available. It scores severity of the disease as DICA 1, DICA 2 and DICA 3. Our aim was to assess the agreement levels for this classification among an endoscopist community setting. METHODS: A total of 66 endoscopists independently scored a set of DD endoscopic videos. The percentages of overall agreement on the DICA score and a free-marginal multirater kappa (κ) coefficient were reported as statistical measures of the inter-rater agreement. RESULTS: The overall agreement levels were: 70.2% for DICA 1, 70.5% for DICA 2, 81.3% for DICA 3. The free marginal κ was: 0.553 for DICA 1, 0.558 for DICA 2, 0.719 for DICA 3. The agreement levels among the expert group were: 78.8% for DICA 1, 80.2% for DICA 2, 88.5% for DICA 3. The free marginal κ among the expert group were: 0.682 for DICA 1, 0.712 for DICA 2, 0.828 for DICA 3. The agreement of expert raters on the single item of the DICA classification was superior to the agreement of the overall group. CONCLUSIONS: The overall inter-rater agreement for DICA score in this study ranges from moderate to good, with a significant improvement in the expert subgroup of raters. Diverticular Inflammation and Complication Assessment is a simple and reproducible endoscopic scoring system

The “dica” endoscopic classification for diverticular disease of the colon shows a significant interobserver agreement among community endoscopists

BACKGROUND AND AIM: An endoscopic classification of Diverticular Disease (DD), called DICA (Diverticular Inflammation and Complication Assessment) is currently available. It scores severity of the disease as DICA 1, DICA 2 and DICA 3. Our aim was to assess the agreement levels for this classification among an endoscopist community setting. METHODS: A total of 66 endoscopists independently scored a set of DD endoscopic videos. The percentages of overall agreement on the DICA score and a free-marginal multirater kappa (κ) coefficient were reported as statistical measures of the inter-rater agreement. RESULTS: The overall agreement levels were: 70.2% for DICA 1, 70.5% for DICA 2, 81.3% for DICA 3. The free marginal κ was: 0.553 for DICA 1, 0.558 for DICA 2, 0.719 for DICA 3. The agreement levels among the expert group were: 78.8% for DICA 1, 80.2% for DICA 2, 88.5% for DICA 3. The free marginal κ among the expert group were: 0.682 for DICA 1, 0.712 for DICA 2, 0.828 for DICA 3. The agreement of expert raters on the single item of the DICA classification was superior to the agreement of the overall group. CONCLUSIONS: The overall inter-rater agreement for DICA score in this study ranges from moderate to good, with a significant improvement in the expert subgroup of raters. Diverticular Inflammation and Complication Assessment is a simple and reproducible endoscopic scoring system