Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Tildrakizumab (TIL), a high-affinity, humanized, immunoglobulin G1κ, anti–interleukin-23p19 monoclonal antibody, has demonstrated efficacy in the treatment of chronic plaque psoriasis.1,2 Here, we evaluate the incidence of gastrointestinal (GI) adverse events (AE), specifically cases of inflammatory bowel disease (IBD), reported during the TIL clinical development program.
Methods: Patients with moderate to severe plaque psoriasis were randomized in 3 large clinical trials: P05495 (phase 2; NCT01225731),1 reSURFACE 1 (phase 3; NCT01722331),2 and reSURFACE 2 (phase 3; NCT01729754).2 In this post hoc analysis, we identified serious GI AEs and new onset or exacerbation of preexisting IBD from a pooled dataset of patients receiving TIL in these 3 studies, which followed patients up to 52 (P05495 and reSURFACE 2) or 64 (reSURFACE 1) weeks. TIL doses were 5 mg, 25 mg, 100 mg, and 200 mg in P05495, and 100 mg and 200 mg in the reSURFACE studies.
Results: In this analysis, we pooled 1911 patients from the 3 trials who received either TIL 100 mg or 200 mg. There were no new cases of IBD reported; among 6 patients with a history of IBD randomized to TIL, none experienced an exacerbation. The number (rate per 100 patient-years) of patients in the pooled dataset who experienced serious GI AEs was 8 (0.80) for TIL 100 mg and 4 (0.43) for TIL 200 mg. These serious GI AEs included abdominal pain, constipation, diverticulum, dyspepsia, gastritis, thrombosed hemorrhoids, esophageal polyp, and pancreatitis (1 patient each) among patients receiving TIL 100 mg and abdominal hernia, upper abdominal pain, acute pancreatitis, and salivary gland enlargement (1 patient each) among patients receiving TIL 200 mg.
Conclusion: Serious GI AEs were found to be infrequent in this post hoc analysis of patients with chronic plaque psoriasis receiving TIL in 3 large randomized clinical trials. No new cases of IBD or exacerbations of preexisting IBD were observed during treatment with TIL.
- Papp K, et al. Br J Dermatol. 2015;173:930–939.
- Reich K, et al. Lancet. 2017;390:276–288.
Analyses were presented at the 2018 American Academy of Dermatology Annual Meeting, February 16–20, 2018, San Diego, CA, USA.
To cite this abstract in AMA style:Gooderham M, Elewski BE, Pariser DM, Sofen H, Mendelsohn AM, Cichanowitz N, Li Q. Incidence of Serious Gastrointestinal Events and Inflammatory Bowel Disease Among Tildrakizumab-Treated Patients with Moderate to Severe Plaque Psoriasis: Data from 3 Large Randomized Clinical Trials [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/incidence-of-serious-gastrointestinal-events-and-inflammatory-bowel-disease-among-tildrakizumab-treated-patients-with-moderate-to-severe-plaque-psoriasis-data-from-3-large-randomized-clinical-trials/. Accessed September 23, 2020.
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