1776: COVID-19 Cases in Patients Treated with Secukinumab: Analysis from the Global Safety Database

Atul Deodhar¹, Andrew Blauvelt², Philip J Mease³, Effie Pournara⁴, Piotr Jagiello⁴, Weibin Bao⁵ and Abhishek Sharma⁶, ¹Oregon Health & Science University, Portland, OR, USA, Portland, OR, ²Oregon Medical Research Center, Portland, OR, USA, Portland, OR, ³Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁴Novartis Pharma AG, Basel, Switzerland, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁶Novartis Healthcare Pvt. Ltd, Hyderabad, India

Background/Purpose: Although patients (pts) with immune-mediated inflammatory diseases who are taking immunosuppressive therapies are not at a significantly greater risk of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection, the reported risk of severe unfavorable outcome or sequalae varies among studies^1,2. As specific data in pts treated with secukinumab are lacking, we analyzed the outcomes of coronavirus disease 2019 (COVID-19) in pts with psoriasis (PsO), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) treated with secukinumab by using the Novartis global safety database.

Methods: The Novartis global safety database was searched for cases reporting COVID-19 in pts receiving secukinumab. Cases reported from clinical trials or post-marketing surveillance between December 2019 and February 2022 were included in the analysis. Potential associations between subgroups (e.g., age, sex, treatment indication) and COVID-19 seriousness or outcomes were examined using Chi-squared testing. P-values were nominal for these exploratory analyses.

Results: As few clinical trials with secukinumab were ongoing, only 8 cases of COVID-19 were reported. All of the cases were hospitalized, and none were suspected to be study drug-related; 7 recovered completely and 1 recovered with sequelae. There were 2948 COVID-19 cases reported from post-marketing surveillance (PsO: N=1126; PsA: N=942; AS: N=469); a higher proportion of pts with AS were younger (43% less than 45 years) compared with pts with PsO or PsA (Table 1). The majority (71.7%) of the cases were not serious. Older age and male sex were associated with COVID-19 seriousness (P< 0.0001 and P=0.0001, respectively; Table 2). Furthermore, pts with AS were less likely to have serious COVID-19 than pts with PsO or PsA (PsO [n=363/1126, 32.2%] vs PsA [n=257/942, 27.3%] vs AS [n=107/469, 22.8%]), potentially due to the younger age in the AS group.

Overall, 27.5% of the reported cases had a complete recovery, 1.6% of the cases were fatal, and for 52.3% the outcome was unknown. Older age and male sex were associated with worse COVID-19 outcome (P< 0.0001 and P=0.0183, respectively; Table 3). Fewer pts with AS had a fatal outcome than pts with PsO or PsA (PsO [n=18/1126, 1.6%] vs PsA [n=14/942, 1.5%] vs AS [n=4/469, 0.9%]), but fewer pts with AS made a complete recovery (PsO [n=390/1126, 34.6%] vs PsA [n=258/942, 27.4%] vs AS [n=114/469, 24.3%]).

Conclusion: This exploratory analysis reports COVID-19 cases in the Novartis global safety database for more than 2 years since the onset of the pandemic. Rates of hospitalization and death from COVID-19 in pts receiving secukinumab were generally in line with reports in immune-mediated inflammatory diseases³ and overall population.⁴ Consistent with published data, older age and male sex had negative impact on both the seriousness and outcome of COVID-19. Potential associations with underlying disease state warrant further investigation.

References
1. Veenstra J, et al. J Am Acad Derm. 2020;83(6):1696‒1703.
2. Mease PJ, et al. EULAR 2022; abstract OP0247.
3. Haberman R, et al. N Eng J Med. 2020;383:85‒88.
4. WHO. Weekly epidemiological update on COVID-19, 18 May. www.who.int.
Table 1: Demographics of patients with COVID-19 by treatment indication from post-marketing surveillance of secukinumab

Table 2: Seriousness levels of COVID-19 cases from post-marketing surveillance (overall, by age and sex)

Table 3: Outcomes of COVID-19 cases from post-marketing surveillance (overall, by age and sex)
Disclosures: A. Deodhar, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer Inc, UCB Pharma, Aurinia, Moonlake; A. Blauvelt, AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Evommune, Forte, Galderma, Incyte, Janssen, Landos, Leo Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, EcoR1, Vibliome; P. Mease, AbbVie, Amgen, Janssen, Novartis, Pfizer Inc, UCB, Sun Pharma, Eli Lilly, Bristol-Myers Squibb(BMS), Celgene, Genentech; E. Pournara, Novartis; P. Jagiello, Novartis; W. Bao, Novartis; A. Sharma, Novartis.