Date: Monday, November 8, 2021
Session Type: Poster Session C
Session Time: 8:30AM-10:30AM
Background/Purpose: Guselkumab (GUS), an anti-interleukin (IL)-23p19-subunit mAb, demonstrated efficacy in VOYAGE (VOY) 1&2 patients (pts) with moderate to severe plaque psoriasis (PsO)1,2 and in DISCOVER (DISC) 1&2 pts with active PsA.3,4 IL-17 inhibitors used to treat PsO and PsA have been associated with exacerbation or new onset of IBD.5 We evaluated the incidence of gastrointestinal (GI)-related and overall serious adverse events (SAEs) from pooled safety data through 1-year of GUS 100 mg treatment from the phase 3 VOY 1&2 and DISC 1&2 trials.
Methods: Using pooled safety data from VOY 1&2 PsO and DISC 1&2 PsA trials, GI-related SAEs were identified using the Medical Dictionary for Regulatory Activities (MedDRA) system-organ class “GI disorders”. Pts with a previous history of IBD were not excluded; IBD history was collected at baseline in DISC 1&2. Rates of overall and GI-related SAEs were calculated as the number of SAEs per 100 pt-years (PY) of follow-up (95% confidence intervals). Data are presented for the placebo (PBO)-controlled period (VOY 1&2: Weeks [W] 0-16; DISC 1&2: W0-24) and through 1-year (VOY 1&2: through W48; DISC 1: through W60, DISC 2: through W52). Events of uveitis and opportunistic infections were also analyzed.
Results: Through the PBO-controlled period, the overall rates of GI-related SAEs per 100 PY for pooled VOY 1&2 were: PBO 0.78 (0.02, 4.34), GUS every (q) 8w 0; and for pooled DISC 1&2: PBO 0.58 (0.01, 3.23), GUS q8w 0.58 (0.01, 3.21), GUS q4w 0. The GI-related SAEs included: VOY 1&2, gastrointestinal hemorrhage (PBO; n=1); and DISC 1&2, IBD (PBO; n=1) and mechanical ileus (GUS q8w; n=1). Through 1-year, overall rates of GI-related SAEs for VOY 1&2 were: combined GUS group (GUS q8w + PBO→GUS) 0.51 (0.17, 1.20); and for DISC 1&2: GUS q8w 0.52 (0.06, 1.88), GUS q4w 0, combined GUS group (GUS q8w + GUS q4w + PBO→GUS) 0.21 (0.02, 0.74). The GI-related SAEs in the combined GUS group for pooled VOY 1&2 included: gastritis, hemorrhoids, inguinal hernia, pancreatitis, and umbilical hernia (0.10/100 PY [0.00, 0.57]; n=1 for each); and in the combined GUS group for pooled DISC 1&2: mechanical ileus and pancreatitis chronic (0.10/100 PY [0.00, 0.57]; n=1 for each). Overall, no cases of exacerbation or new onset of IBD were reported in GUS-treated pts, including 2 pts with a prior history of IBD in DISC 1&2 (total PY of follow-up for the combined GUS groups in VOY and DISC were 974 and 973, respectively). Through the PBO-controlled period, rates of overall SAEs for GUS-treated pts were comparable to PBO-pts and SAE rates remained low through 1-year of follow-up in VOY 1&2 and DISC 1&2. No cases of uveitis, opportunistic infections, or tuberculosis were reported in GUS-treated pts through 1-year.
Conclusion: Through 1-year of follow-up with GUS treatment in pooled VOY 1&2 and DISC 1&2, GI-related SAE rates were low. There were no reported cases of uveitis, opportunistic infections, or new onset/exacerbation of IBD in GUS-treated pts. No new safety concerns were identified through 1-year.
1. Blauvelt A., et al. J Am Acad Dermatol. 2017;76:405-17
2. Reich K., et al. J Am Acad Dermatol. 2017;76:418-31
3. Deodhar A., et al. Lancet. 2020;395:1115-25
4. Mease P.J., et al. Lancet. 2020;395:1126-36
5. Hohenberger M., et al. J Dermatolog Treat. 2018;29:13-8
To cite this abstract in AMA style:Mease P, Foley P, Reich K, Bagel J, Lebwohl M, Yang Y, Shawi M, Miller M, Kollmeier A, Hsia E, Xu X, Izutsu M, Ramachandran P, Sheng S, You Y, Helliwell P, Boehncke W. Low Incidence of Gastrointestinal-related and Overall Serious Adverse Events Among Guselkumab-treated Patients: Pooled Analyses of VOYAGE 1 & 2 and DISCOVER 1 & 2 Through 1-Year [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/low-incidence-of-gastrointestinal-related-and-overall-serious-adverse-events-among-guselkumab-treated-patients-pooled-analyses-of-voyage-1-2-and-discover-1-2-through-1-year/. Accessed October 1, 2022.
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