Upadacitinib appears to be an efficacious therapy for moderately-to-severely ulcerative colitis

Upadacitinib 45 mg induction therapy followed by 30 mg maintenance therapy showed the highest efficacy in a Bayesian network meta-analysis, indirectly comparing therapies for patients with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of upadacitinib was similar to the safety profiles of other advanced therapies for this population.

The comparative efficacy and safety of recently developed therapies for patients with UC has not been established. A Bayesian network meta-analysis was conducted by Prof. Remo Panaccione (University of Calgary, Canada) and colleagues to compare advanced induction and maintenance therapies for patients with moderately to severely active UC [1]. The study included all therapies with published phase 3 data (i.e. ustekinumab, filgotinib, tofacitinib, infliximab, vedolizumab, adalimumab, golimumab, upadacitinib, and ozanimod). All therapies were compared with placebo.

In biologic-naïve participants, upadacitinib 45 mg induction therapy displayed the largest difference in clinical response^a rates compared with placebo (OR 6.9). Also, filgotinib 200 mg (OR 3.4), tofacitinib (OR 3.1), ustekinumab (OR 3.6), and infliximab 5 mg (OR 3.4) displayed high response rates. Endoscopic improvement^b rates confirmed the superior efficacy of upadacitinib induction therapy (OR 6.9), and ozanimod demonstrated high efficacy rates compared with placebo as well (OR 3.6). In biologic-exposed participants, the JAK inhibitors as a class performed well in inducing clinical remission, especially upadacitinib (OR 9.8) and tofacitinib (OR 5.2). In addition, ustekinumab was efficacious in this population, with an OR of 5.9 in inducing clinical remission compared with placebo.

Treat-through analysis in biologic-naïve participants after induction and maintenance therapy showed the highest clinical response rates in participants treated with upadacitinib 45 mg induction and 30 mg maintenance therapy (66.7%), followed by upadacitinib 45 mg induction and 15 mg maintenance therapy (56.6%). This result was confirmed in biologic-experienced participants, with corresponding clinical response rates of 59.8% and 52.2% (see Figure).

Figure: Clinical response rate treat-through analysis in bio-naïve and bio-exposed participants [1]



 

 

 

 

 

 

 

The safety analysis showed that upadacitinib induction and maintenance therapies were not associated with a higher rate of adverse events than other advanced therapies. The rate of serious adverse events in participants treated with upadacitinib induction therapy and upadacitinib 15 mg or 30 mg maintenance therapy were 3.6%, 4.4%, and 3.8%, respectively.

Prof. Panaccione concluded that upadacitinib induction and maintenance therapies appear to be more efficacious than other advanced therapies regarding clinical response, clinical remission, and endoscopic response rates in both biologic-naïve and biologic-experienced patients with moderately-to-severely UC.

a. Clinical response is defined as a decrease from baseline in full Mayo Score ≥3 points and ≥30% with decrease in rectal bleeding score of ≥1 or absolute rectal bleeding score ≤1

b. Endoscopic improvement is defined as an endoscopic score ≤1.

1. Panaccione R, et al. Efficacy and safety of advanced induction and maintenance therapies in patients with moderately to severely active Ulcerative Colitis: An indirect treatment comparison using Bayesian network meta-analysis. OP34, ECCO 2022, 16–19 February.

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Posted on 12 April 20228 April 2024