A switch from originator-adalimumab to the biosimilar SB5 in patients with Crohn's disease: an analysis of two propensity score-matched cohorts.

BACKGROUND/AIMS: Originator-adalimumab, an established treatment for patients with Crohn's disease (CD), showed no difference in efficacy or adverse events versus adalimumab biosimilar SB5 (SB5-adalimumab) over 10 weeks (W) of treatment. To understand the long-term effectiveness of SB5-adalimumab in CD, patients switched from originator-adalimumab to SB5-adalimumab were compared with patients remaining on originator-adalimumab over 104 W. METHODS: Data on patients aged ≥18 years, diagnosed with CD and treated at ISCARE, were collected prospectively from July 2018 to January 2021. Primary outcome: clinical disease activity at W52, measured by Harvey-Bradshaw index (HBI). Secondary outcomes: C-reactive protein (CRP), faecal calprotectin (FC) and adalimumab concentrations at W10, 26, 52 and 104, and treatment persistence. To ensure comparable cohorts, patients were propensity score (PS)-matched for age, gender and disease activity. RESULTS: After matching, 54 patients remained per cohort. At W52, mean (SD) HBI score was 3.2 (2.5) for originator-adalimumab and 4.0 [3.6] for SB5-adalimumab (difference [95% CI] -0.78 [-2.8, 1.3]; n = 18/cohort); no clinically meaningful differences in CRP, FC or drug concentrations were noted. Kaplan-Meier's estimates (95% CI) of remaining on treatment were originator-adalimumab: 0.870 (0.785-0.965) versus SB5-adalimumab: 0.648 (0.533-0.789) at W52 and significantly lower for SB5-adalimumab versus originator-adalimumab (p < .001) over 104 W. Local skin reaction events/pain was the main reason for treatment discontinuation in the SB5-adalimumab cohort (n = 20/54 [37%]). CONCLUSIONS: These long-term results of CD patients receiving originator-adalimumab or following nonmedical switch to SB5-adalimumab show similar therapeutic effects on clinical disease activity, biological parameters and pharmacokinetic profile in both cohorts from 52 to 104 W. A separation in persistence was observed beyond W26, mainly due to differences in local reactions at the injection site.

Switching From Originator Adalimumab to the Biosimilar SB5 in Patients With Inflammatory Bowel Disease: Short-term Experience From a Single Tertiary Clinical Centre.

BACKGROUND AND AIMS: Patients' perspectives after switching from originator to biosimilar adalimumab have yet to be assessed. We evaluated the efficacy of switching from the originator adalimumab to a biosimilar compound [SB5] in patients with inflammatory bowel disease [IBD]. METHODS: Data on IBD patients who were switched from the originator to biosimilar adalimumab [SB5] at IBD Center ISCARE were analysed. Disease activity was assessed using standard clinical indices (Harvey-Bradshaw index [HBI] for Crohn's disease [CD] and partial Mayo score for ulcerative colitis [UC]), and laboratory parameters (C-reactive protein [CRP] and faecal calprotectin [FC]). Trough levels and anti-drug antibodies were measured. Patients were evaluated 10 weeks [W10] after the switch, and results were compared with the control group of patients on originator compound. RESULTS: A total of 93 patients switched to biosimilar adalimumab were included [CD 86%] and were matched to 93 controls for age, gender, diagnosis, and disease activity. There was no difference in the disease activity in either SWITCH or ORIGINATOR cohorts between Weeks 0 and 10. Similarly, no difference was found between cohorts at both prespecified time points. Moreover, no significant differences in CRP or FC concentrations were seen between W0 and W10 either in the SWITCH, or in the ORIGINATOR cohort [p >0.05]. Adalimumab serum trough levels remained stable after the switch. No new safety signals were detected. CONCLUSIONS: Our study confirmed that switching IBD patients from the originator adalimumab to a biosimilar compound [SB5] does not affect treatment efficacy.

Infliximab Biosimilar (Remsima™) in Therapy of Inflammatory Bowel Diseases Patients: Experience from One Tertiary Inflammatory Bowel Diseases Centre.

BACKGROUND: The evidence on the efficacy and safety of biosimilar infliximab (IFX) in patients with inflammatory bowel diseases (IBD) is sparse. METHODS: Consecutive IBD patients visiting our centre were included. One cohort composed of prospectively followed patients who were switched from original to biosimilar IFX between January and March 2015. The second cohort included retrospectively assessed anti-tumor necrosis factor α-naïve patients who started therapy between January 2015 and January 2016. Disease activity was assessed using standard clinical indices, endoscopic evaluation, and laboratory parameters (blood count, C-reactive protein (CRP) and fecal calprotectin (FC)). Trough levels and anti-drug antibodies (ATIs) were also measured. Patients were evaluated 56 weeks (W56) after switch and at week 14 (W14) and week 46 (W46) in the naïve cohort. RESULTS: Seventy-four IBD patients were switched to biosimilar IFX and 119 naïve patients newly initiated therapy with the preparation. Disease activity remained stable in a majority of switched patients (remission at week 0 (W0) vs. W56: 72.2 vs. 77.8%; median difference of both Harvey-Bradshaw index and Simple Clinical Colitis Activity Index between W0 and W56 was 0). When W0 and W56 were compared, no significant difference in CRP (4.3 ± 8.0 vs. 3.3 ± 3.8 mg/l; p = 0.89) and FC (135 ± 153 vs. 199 ± 225 µg/g; p = 0.17) was observed. In total, 92% of Crohn's disease (CD) and 83% of ulcerative colitis (UC) patients responded to induction therapy (W14) with biosimilar IFX. At W46, the response rate was 86% in CD and 64% in UC. Moreover, half of UC patients experienced mucosal healing at W14 and improvement of perianal disease occurred in 95% of CD at W46. In this cohort, clear steroid-sparing effect was observed. No increase in immunogenicity was found in switched patients (ATI positivity: 9.5 vs. 6.0%, p = 0.54) and the type and frequency of adverse events were comparable to the original preparation in both cohorts. CONCLUSION: Switching of IBD patients from original to biosimilar IFX is effective and safe.

[Is there any role for gastric balloon in obesity treatment?]. / Mají zaludecní balóny úlohu v lécbe obezity?

Gastric balloon application is not an effective method for obesity treatment. It is a high risk treatment with many possible complications. To detect balloon leak methylene blue is used. The only indication for the use of balloon is preparing patients with morbid obesity for gastric banding using balloon for 4-6 months. This initial balloon-induced weight loss does not treat obesity definitely, but is used as a preoperative preparation for surgical obesity treatment.

[Characteristics of immunity in patients with destructive pulmonary tuberculosis]. / Osobennosti immuniteta u bol'nykh s destruktivnym tuberkulezom legkikh.

Parameters of systemic immunity, activity of cation proteins of neutrophilic granulocytes and individual blood serum proteins were studied in two groups of patients: with newly diagnosed (83) and chronic destructive pulmonary tuberculosis (105). Four levels of T-lymphocytes were established per their absolute content in 1 ul of the peripheral blood, which had different interconnection with cell response intensity to mitogenic PHA stimulation and the values of the lysosomal cation++ test in both groups of patients. Indications for the prescription of immune active preparations based upon the T-cell level and, when necessary, supplemented by information related to the values of BTR with PHA and BTR with PPD were developed for both groups of patients independently of hereditary consolidated serum proteins.

[Regulatory activity of lymphocytes in patients with pulmonary tuberculosis]. / Reguliatornaia aktivnost' limfotsitov u bol'nykh tuberkulezom legkikh.

Functional activity of T-lymphocyte suppressors (spontaneous and Con-A induced) has been studied in 17 patients with destructive pulmonary tuberculosis. Patients with ++fibrous-cavernous pulmonary tuberculosis were found to have characteristic disturbances of the regulatory lymphocyte function and a high index of theophylline-resistant E-RFC/theophylline-sensitive E-RFC in the presence of a general reduction of the immunity T-system indices. A higher balance of the regulatory lymphocytes was seen in patients with infiltrative tuberculosis in various disorders of the immunologic parameters.

[Types of immunograms in new cases of pulmonary tuberculosis]. / Tipy immunogramm u vpervye vyiavlennykh bol'nykh tuberkulezom legkikh.

Systemic immunity and nonspecific resistance were studied in 127 new cases of pulmonary tuberculosis with the lysosomal cationic test (LCT). 4 types of immunograms based on the absolute count of T-lymphocytes in peripheral blood were revealed. It was shown that the immunogram types corresponded to the disease clinicoroentgenological picture which made it possible to perform individual pathogenetic therapy with thymus immunoactive preparations. A normalizing effect of T-activin on the lowered indices of the LCT was observed.