Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab
Background: Long-term data on inflammatory bowel disease (IBD) patients switched from originator to biosimilar infliximab SB2 are lacking. The aim of the conducted study was to investigate the effectiveness, immunogenicity and safety of a large prospectively followed-up IBD patient cohort that was e...
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2021-01-01
|
| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/1756284820982802 |
| _version_ | 1830271653139972096 |
|---|---|
| author | Sarah Fischer Sarah Cohnen Entcho Klenske Heike Schmitt Francesco Vitali Simon Hirschmann Andreas Ramming Sebastian Zundler Timo Rath Sabine Krebs Frank Dörje Wolfgang Uter Daniel Nagore Sebastian Meyer Markus F. Neurath Raja Atreya |
| author_facet | Sarah Fischer Sarah Cohnen Entcho Klenske Heike Schmitt Francesco Vitali Simon Hirschmann Andreas Ramming Sebastian Zundler Timo Rath Sabine Krebs Frank Dörje Wolfgang Uter Daniel Nagore Sebastian Meyer Markus F. Neurath Raja Atreya |
| author_sort | Sarah Fischer |
| collection | DOAJ |
| description | Background: Long-term data on inflammatory bowel disease (IBD) patients switched from originator to biosimilar infliximab SB2 are lacking. The aim of the conducted study was to investigate the effectiveness, immunogenicity and safety of a large prospectively followed-up IBD patient cohort that was entirely switched from originator infliximab to biosimilar SB2 treatment. Methods: This was a prospective, single-center, longitudinal, observational study describing clinical outcomes in IBD patients, over an 80-week period following switch from originator infliximab to SB2. Primary outcome measures were change of disease activity [Harvey-Bradshaw Index for Crohn’s disease (CD), partial Mayo Score for ulcerative colitis (UC)], C-reactive protein (CRP), infliximab trough levels (TLs), anti-drug antibodies (ADAs) and adverse events. Results: One hundred and forty-four IBD patients (94 CD, 50 UC), with median duration of 30.5 months’ (range 2–110) treatment with originator infliximab were evaluated. Mean change of disease activity compared with baseline was −0.9 (SD 2.6), –0.4 (2.2) and –0.4 (2.0) in CD; 0.1 (1.1), 0.1 (1.1) and 0.1 (1.3) in UC patients at weeks 24, 48 and 72. Median infliximab TLs were 6.2 µg/ml (interquartile range 2.3–12.2), 5.0 µg/ml (2.7–10.0), 6.6 µg/ml (3.5–12.4) and 5.1 µg/ml (2.7–10.9) at baseline and weeks 24, 48 and 72. Median CRP levels were within normal ranges throughout the study. After the switch, 9.8% of the patients developed new ADAs. Persistence on SB2 was 90% (95% confidence interval 0.85–0.95), 79% (0.72–0.86), 72% (0.64–0.80) at weeks 26, 52 and 78. Serious adverse events occurred in 11 patients. Conclusion: Over the individual patient follow-up of 80 weeks, switch to biosimilar SB2 from originator infliximab does not result in increased disease activity or changed immunogenicity patterns. The switch to SB2 was well tolerated. |
| first_indexed | 2024-12-18T23:10:12Z |
| format | Article |
| id | doaj.art-3859f2e90d9c47aca76c0449ceefa88f |
| institution | Directory Open Access Journal |
| issn | 1756-2848 |
| language | English |
| last_indexed | 2024-12-18T23:10:12Z |
| publishDate | 2021-01-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj.art-3859f2e90d9c47aca76c0449ceefa88f2022-12-21T20:48:22ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-28482021-01-011410.1177/1756284820982802Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximabSarah FischerSarah CohnenEntcho KlenskeHeike SchmittFrancesco VitaliSimon HirschmannAndreas RammingSebastian ZundlerTimo RathSabine KrebsFrank DörjeWolfgang UterDaniel NagoreSebastian MeyerMarkus F. NeurathRaja AtreyaBackground: Long-term data on inflammatory bowel disease (IBD) patients switched from originator to biosimilar infliximab SB2 are lacking. The aim of the conducted study was to investigate the effectiveness, immunogenicity and safety of a large prospectively followed-up IBD patient cohort that was entirely switched from originator infliximab to biosimilar SB2 treatment. Methods: This was a prospective, single-center, longitudinal, observational study describing clinical outcomes in IBD patients, over an 80-week period following switch from originator infliximab to SB2. Primary outcome measures were change of disease activity [Harvey-Bradshaw Index for Crohn’s disease (CD), partial Mayo Score for ulcerative colitis (UC)], C-reactive protein (CRP), infliximab trough levels (TLs), anti-drug antibodies (ADAs) and adverse events. Results: One hundred and forty-four IBD patients (94 CD, 50 UC), with median duration of 30.5 months’ (range 2–110) treatment with originator infliximab were evaluated. Mean change of disease activity compared with baseline was −0.9 (SD 2.6), –0.4 (2.2) and –0.4 (2.0) in CD; 0.1 (1.1), 0.1 (1.1) and 0.1 (1.3) in UC patients at weeks 24, 48 and 72. Median infliximab TLs were 6.2 µg/ml (interquartile range 2.3–12.2), 5.0 µg/ml (2.7–10.0), 6.6 µg/ml (3.5–12.4) and 5.1 µg/ml (2.7–10.9) at baseline and weeks 24, 48 and 72. Median CRP levels were within normal ranges throughout the study. After the switch, 9.8% of the patients developed new ADAs. Persistence on SB2 was 90% (95% confidence interval 0.85–0.95), 79% (0.72–0.86), 72% (0.64–0.80) at weeks 26, 52 and 78. Serious adverse events occurred in 11 patients. Conclusion: Over the individual patient follow-up of 80 weeks, switch to biosimilar SB2 from originator infliximab does not result in increased disease activity or changed immunogenicity patterns. The switch to SB2 was well tolerated.https://doi.org/10.1177/1756284820982802 |
| spellingShingle | Sarah Fischer Sarah Cohnen Entcho Klenske Heike Schmitt Francesco Vitali Simon Hirschmann Andreas Ramming Sebastian Zundler Timo Rath Sabine Krebs Frank Dörje Wolfgang Uter Daniel Nagore Sebastian Meyer Markus F. Neurath Raja Atreya Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab Therapeutic Advances in Gastroenterology |
| title | Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab |
| title_full | Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab |
| title_fullStr | Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab |
| title_full_unstemmed | Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab |
| title_short | Long-term effectiveness, safety and immunogenicity of the biosimilar SB2 in inflammatory bowel disease patients after switching from originator infliximab |
| title_sort | long term effectiveness safety and immunogenicity of the biosimilar sb2 in inflammatory bowel disease patients after switching from originator infliximab |
| url | https://doi.org/10.1177/1756284820982802 |
| work_keys_str_mv | AT sarahfischer longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT sarahcohnen longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT entchoklenske longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT heikeschmitt longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT francescovitali longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT simonhirschmann longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT andreasramming longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT sebastianzundler longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT timorath longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT sabinekrebs longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT frankdorje longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT wolfganguter longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT danielnagore longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT sebastianmeyer longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT markusfneurath longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab AT rajaatreya longtermeffectivenesssafetyandimmunogenicityofthebiosimilarsb2ininflammatoryboweldiseasepatientsafterswitchingfromoriginatorinfliximab |