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The results show 83% of patients in the combination group achieved clinical response at week 12, compared to 61% of the golimumab monotherapy group and 75% of the guselkumab group.
A team, led by Brian G. Feagan, MD, Western University, assessed whether guselkumab with golimumab combination therapy was a more effective option for patients with ulcerative colitis than either treatment as a monotherapy.
While the introduction of new monoclonal antibodies and oral therapies have improved care for ulcerative colitis, clinical remission rates remain low.
In the randomized, double-blind, controlled, proof-of-concept trial, the investigators examined 358 patients at 54 hospitals, academic medical centers, or private practices in 9 countries between November 20, 2018 and November 15, 2021. The mean age was 38.4 years.
Each participant was aged 18-65 years with a confirmed diagnosis of ulcerative colitis for at least 3 months prior to screening and moderately-to-severely active ulcerative colitis, defined by a Mayo score of 6-12 and a centrally-read baseline endoscopy subscore of 2 or higher.
The patients were treated with eitherthe combination therapy (n = 71), defined as subcutaneous golimumab 200 mg at week 0, subcutaneous golimumab 100 mg at weeks 2, 6, and 10, and intravenous guselkumab 200 mg at weeks 0, 4, and 8, followed by subcutaneous guselkumab monotherapy 100 mg every 8 weeks for 32 weeks), golimumab monotherapy (n = 72), which was subcutaneous golimumab 200 mg at week 0 followed by subcutaneous golimumab 100 mg at week 2 and every 4 weeks thereafter for 34 weeks, or guselkumab monotherapy (n = 71), consisting of intravenous guselkumab 200 mg at weeks 0, 4, and 8, followed by subcutaneous guselkumab 100 mg every 8 weeks thereafter for 32 weeks.
The investigators sought a primary endpoint of clinical response at week 12, defined as either a decrease in rectal bleeding scores of at least 1 point or a rectal bleeding score of 0 or 1.
The results show 83% (n = 59) of patients in the combination group achieved clinical response at week 12, compared to 61% ( n = 44) in the golimumab monotherapy group (adjusted treatment difference, 22.1; 80% confidence interval [CI], 12.9-31.1; nominal
P = 0.0032) and 75% (n = 53) of the guselkumab group (adjusted treatment difference, 8.5%; 80% CI, -0.2 to 17.1; nominal P = 0.2155).
The results at week 50 show 63% (n = 45) of the combination therapy group, 76% (n = 55) of the golimumab monotherapy group, and 65% (n = 46) in the guselkumab monotherapy group reported at least 1 adverse event.
The most common adverse events were ulcerative colitis, upper respiratory tract infections, headache, anemia, nasopharyngitis, neutropenia, and pyrexia, with no deaths, malignancies, or cases of tuberculosis identified during the combination induction period. There was 1 case of tuberculosis in the combination group and 1 case of colon adenocarcinoma in the guselkumab group after week 12. In addition, 2 deaths occurred after the final dose, a poisoning in the combination group and a death caused by COVID-18 in the guselkumab group.
“Data from this proof-of-concept study suggest that combination therapy with guselkumab and golimumab might be more effective for ulcerative colitis than therapy with either drug alone,” the authors wrote. “These findings require confirmation in larger trials.”
Feagan, B. G., Sands, B. E., Sandborn, W. J., Germinaro, M., Vetter, M., Shao, J., Sheng, S., Johanns, J., Panés, J., Tkachev, A., Kalimullina, D., Petryka, R., Osipenko, M., Tsarynna, N., Bilianskyi, L., Kleczkowski, D., Yurkiv, A., Woynarowski, M., Abrahamovych, O., … Ritter, T. (2023). Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (Vega): A randomized, double-blind, controlled, phase 2, proof-of-concept trial. The Lancet Gastroenterology & Hepatology, 8(4), 307–320. https://doi.org/10.1016/s2468-1253(22)00427-7