Consistent safety profile with up to 5 years of continuous treatment with guselkumab: Pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis
Por:
Blauvelt, A, Tsai, TF, Langley, RG, Miller, M, Shen, YK, You, Y, Yang, YW, Papp, KA, Puig, L
Publicada:
1 abr 2022
Ahead of Print:
1 mar 2022
Resumen:
Background: Guselkumab effectively treats moderate-to-severe psoriasis.
Methods: Patients were randomized to guselkumab, placebo with crossover to guselkumab at week 16, or adalimumab. The studies were identical through week 24. VOYAGE 1 evaluated continuous guselkumab treatment (adalimumab-crossover-to-guselkumab at week 52), while VOYAGE 2 assessed randomized withdrawal/retreatment (weeks 28-76). Open-label guselkumab treatment was administered starting at week 52 in VOYAGE 1 and week 76 in VOYAGE 2 and continued through week 252. Pooled safety data were adjusted by exposure and analyzed in the guselkumab groups, including placebo-crossover-toguselkumab (n = 1221) and adalimumab-crossover-to-guselkumab (n = 500), through week 264.
Results: Patients were followed for a total of 7166 patient-years (PY). Overall, 1349 of 1721 guselkumab-treated patients (78.4%) continued treatment through week 252. The rates of adverse and serious adverse events were 149/100 PY and 5.01/100 PY, respectively. Rates of adverse events of interest were low: serious infections (0.85/100 PY), nonmelanoma skin cancer (0.34/100 PY), malignancies other than nonmelanoma skin cancer (0.45/100 PY), and major adverse cardiovascular events (0.29/100 PY). Year-to-year variability was evident, but no increasing trend was observed.
Limitations: No direct treatment comparisons were possible after week 52.
Conclusion: The safety profile remained consistent and favorable during 5 years of continuous guselkumab treatment of psoriasis.
Filiaciones:
Blauvelt, A:
Oregon Med Res Ctr, 9495 SW Locust St,Suite G, Portland, OR 97223 USA
Tsai, TF:
Natl Taiwan Univ Hosp, Taipei, Taiwan
Langley, RG:
Dalhousie Univ, Halifax, NS, Canada
Miller, M:
Janssen Res & Dev LLC, Spring House, PA USA
Shen, YK:
Janssen Res & Dev LLC, Spring House, PA USA
You, Y:
Janssen Res & Dev LLC, Spring House, PA USA
Yang, YW:
Janssen Pharmaceut Co Johnson & Johnson, Immunol Global Med Affairs, Horsham, PA USA
Papp, KA:
K Papp Clin Res & Prob Res Inc, Waterloo, ON, Canada
Puig, L:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
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