Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest
Background Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure. Objectives To present 5-year safety data from reSURFACE 1/2 phase 3 trials as EAIRs of events per 100 PYs of exposure, and t...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | Journal of Dermatological Treatment |
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| Online Access: | http://dx.doi.org/10.1080/09546634.2023.2220447 |
| _version_ | 1827816506190200832 |
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| author | Alexander Egeberg Denis Jullien Kristian Gaarn Du Jardin Diamant Thaçi |
| author_facet | Alexander Egeberg Denis Jullien Kristian Gaarn Du Jardin Diamant Thaçi |
| author_sort | Alexander Egeberg |
| collection | DOAJ |
| description | Background Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure. Objectives To present 5-year safety data from reSURFACE 1/2 phase 3 trials as EAIRs of events per 100 PYs of exposure, and the number needed to harm (NNH) for one adverse event of special interest (AESI) to occur. Methods Pooled analysis from two randomized controlled trials in patients with moderate-to-severe plaque psoriasis (n = 1800). PSOLAR registry was used as safety reference data for NNH estimation. Results Rates of AESI with tildrakizumab were comparable with rates reported in PSOLAR. The NNH for one-year severe infection occurrence was 412 with tildrakizumab 200 mg, and negative for tildrakizumab 100 mg due to lower rates in reSURFACE trials; the NNH for malignancy was 990 for one year with tildrakizumab 100 mg (negative for tildrakizumab 200 mg); and the NNH for major adverse cardiovascular events was 355 for one year with tildrakizumab 200 mg (negative for tildrakizumab 100 mg). Conclusion Tildrakizumab demonstrated a favorable safety profile over 5 years with low rates of AESI, comparable to those of the PSOLAR. Consequently, the NNH for AESI with tildrakizumab were very high or negative due to lower event rates for tildrakizumab. |
| first_indexed | 2024-03-12T00:15:17Z |
| format | Article |
| id | doaj.art-c4b92278d4af48e2a8cee67af1d1b83c |
| institution | Directory Open Access Journal |
| issn | 0954-6634 1471-1753 |
| language | English |
| last_indexed | 2024-03-12T00:15:17Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj.art-c4b92278d4af48e2a8cee67af1d1b83c2023-09-15T14:28:53ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532023-12-0134110.1080/09546634.2023.22204472220447Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interestAlexander Egeberg0Denis Jullien1Kristian Gaarn Du Jardin2Diamant Thaçi3Department of Dermatology, Bispebjerg and Frederiksberg Hospital, University of CopenhagenHospices Civils de Lyon, Hôpital E. Herriot, Service de Dermatologie, Université Lyon-1; INSERM UnitéAlmirall R&DInstitute and Comprehensive Center for Inflammation Medicine, University of LübeckBackground Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure. Objectives To present 5-year safety data from reSURFACE 1/2 phase 3 trials as EAIRs of events per 100 PYs of exposure, and the number needed to harm (NNH) for one adverse event of special interest (AESI) to occur. Methods Pooled analysis from two randomized controlled trials in patients with moderate-to-severe plaque psoriasis (n = 1800). PSOLAR registry was used as safety reference data for NNH estimation. Results Rates of AESI with tildrakizumab were comparable with rates reported in PSOLAR. The NNH for one-year severe infection occurrence was 412 with tildrakizumab 200 mg, and negative for tildrakizumab 100 mg due to lower rates in reSURFACE trials; the NNH for malignancy was 990 for one year with tildrakizumab 100 mg (negative for tildrakizumab 200 mg); and the NNH for major adverse cardiovascular events was 355 for one year with tildrakizumab 200 mg (negative for tildrakizumab 100 mg). Conclusion Tildrakizumab demonstrated a favorable safety profile over 5 years with low rates of AESI, comparable to those of the PSOLAR. Consequently, the NNH for AESI with tildrakizumab were very high or negative due to lower event rates for tildrakizumab.http://dx.doi.org/10.1080/09546634.2023.2220447adverse event of special interestnumber needed to harmpsoriasistildrakizumab |
| spellingShingle | Alexander Egeberg Denis Jullien Kristian Gaarn Du Jardin Diamant Thaçi Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest Journal of Dermatological Treatment adverse event of special interest number needed to harm psoriasis tildrakizumab |
| title | Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest |
| title_full | Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest |
| title_fullStr | Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest |
| title_full_unstemmed | Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest |
| title_short | Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest |
| title_sort | five year safety of tildrakizumab in patients with moderate to severe psoriasis from two phase 3 trials resurface 1 and resurface 2 number needed to harm for occurrence of adverse events of special interest |
| topic | adverse event of special interest number needed to harm psoriasis tildrakizumab |
| url | http://dx.doi.org/10.1080/09546634.2023.2220447 |
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