Mirikizumab as induction and maintenance therapy for ulcerative colitis

N Engl J Med 2023;388(26):2444–2455 doi: 10.1056/NEJMoa2207940

Mirikizumab was more effective than placebo in inducing and maintaining clinical remission in patients with moderately to severely active ulcerative colitis. D’Haens, et al. also noted that opportunistic infections and cancer developed in a small number of mirikizumab-treated patients.

The results of two induction studies (UC1 and UC2) and a maintenance study (UC3) show upadacitinib superiority to placebo in treating ulcerative colitis (UC). Rates of clinical remission were significantly higher for all upadacitinib doses versus placebo in all three studies.

Treatment of patients with UC with filgotinib 200 mg was associated with an increase in clinical remission at Week 10 and Week 58. The proportion of patients with clinical remission at Week 58 was significantly greater in patients who continued FIL 200 mg therapy throughout the trial. The incidence of TEAEs was similar across all treatment groups.

Tofacitinib as induction and maintenance therapy for ulcerative colitis

N Engl J Med. 2017 May 4;376(18):1723-1736. DOI 10.1056/NEJMoa1606910

Tofacitinib, at a dose of 10 mg twice daily, was more effective than placebo for induction of remission and mucosal healing in patients with moderately to severely active ulcerative colitis. Furthermore, maintenance therapy with tofacitinib, at a dose of either 5 mg or 10 mg twice daily, was more effective than placebo in sustaining remission and mucosal healing.

April 2024

Deucravacitinib improved physical and social functioning, mental health, fatigue, and pain in a
Phase 2 trial in patients with active PsA. Here, investigators aimed to report the impact of deucravacitinib in a Phase 2 study in patients with active PsA from a patient perspective.

Significant improvements in overall disease activity, enthesitis and dactylitis, and skin psoriasis were observed by Week 8 and maintained or improved through Week 100 in both guselkumab treatment groups. Coates et al conducted a post-hoc analysis of the Phase 3 DISCOVER-2 trial to investigate the long-term (100-week) efficacy of guselkumab across GRAPPA-identified PsA domains.

Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis

N Engl J Med 2016;375:345–56. doi: 10.1056/NEJMoa1512711

Gordon, et al. pool the results of UNCOVER-1, UNCOVER-2, and UNCOVER-3 to show that ixekizumab increases the proportion of patients achieving an sPGA score of 0/1 or PASI 75 versus placebo. Adverse events related to ixekizumab treatment included neutropenia, candidal infections, and inflammatory bowel disease.

Phase 3 studies comparing brodalumab with ustekinumab in psoriasis

N Engl J Med 2015;373:1318–28. doi: 10.1056/NEJMoa1503824

Brodalumab treatment resulted in a rapid reduction in the signs and symptoms of PsO. The median time to a PASI 75 response with 210 mg of brodalumab Q2W was 4 weeks, approximately twice as fast as the median time to a response with ustekinumab.

Researchers reported the safety and efficacy of deucravacitinib over 2 years in patients with chronic plaque PsO. The most frequently reported AEs were nasopharyngitis, URTI, and COVID-19.

Week 16 primary outcomes of improved PASI 90 response and sPGA score demonstrated Mirikizumab superiority to placebo and non-inferiority to secukinumab. This study presented results from the OASIS-2 trial on the safety and efficacy of mirikizumab compared with secukinumab and placebo in patients with moderate-to-severe plaque psoriasis.