Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis

Journal Reference: Adv Rheumatol. 2024 Dec 18;64:87 doi: 10.1186/s42358-024-00402-x

Deodhar et al. conducted a pooled analysis of Phase 2 and 3 RCT data to assess the safety of tofacitinib in AS. The results showed that tofacitinib 5 mg BID had a tolerable safety profile over 48 weeks, consistent with its use in other inflammatory conditions such as RA and PsA.

November 2024

Mease et al. conducted a post-hoc analysis of the phase 3 DISCOVER-2 trial to assess the persistence of clinically relevant improvements with guselkumab in biologic-naïve patients with PsA. The analysis showed that guselkumab maintained clinical improvements in joint and skin domains at consecutive dosing visits (Q8W) and over time.

Baraliakos et al. assessed the long-term efficacy and safety of upadacitinib in patients with active ankylosing spondylitis who were refractory to biologic therapy. At week 104, the treatment sustained improvements in disease activity and functional outcomes with low rates of radiographic progression and no new safety signals.

September 2024

Deodhar et al. evaluated the efficacy and safety of intravenous secukinumab in patients with active axial spondyloarthritis. The study found a significant improvement in the ASAS40 response at Week 16 (40.9% vs 22.9% in placebo, P<0.0001), with responses maintained through Week 52. No new safety signals were observed.

August 2024

Deodhar et al. investigated the impact on efficacy and safety of escalating secukinumab dose from 150mg to 300mg Q4W in AS patients who did not achieve inactive disease during an initial 16-week period of 150mg secukinumab. At Week 52, clinical safety response rates were similar across groups continuing with 150mg or escalating to 300mg secukinumab.

July 2024

In a large pool of Phase 2b/3 trial data, the incidence rate of uveitis with bimekizumab over 2034.4 patient years (PYs) remained low at 1.2/100 PYs, suggesting bimekizumab may be an appropriate treatment option for patients with axSpA and uveitis. Compared with placebo, bimekizumab had a lower incidence rate of uveitis in patients with and without a history of uveitis.

June 2024

Ritchlin et al. conducted a post hoc analysis of the DISCOVER-2 trial, evaluating the efficacy of guselkumab in biologic-naïve patients with PsA. Guselkumab provided durable disease control across key PsA domains and PROs over 2 years, regardless of baseline characteristics. A significant proportion of patients achieved stringent endpoints such as ACR50/70, complete skin clearance, and resolution of dactylitis/enthesitis.

Bimekizumab (BKZ) treatment led to early improvements in physical function, sleep, work productivity, and overall health-related quality of life at Week 16 in patients across the full axSpA disease spectrum, which were sustained through Week 52. Dubreuil et al. investigated treatment impact over one year using BASFI, MOS-Sleep-R, SF-36 PCS/MCS, WPAI:axSpA, and ASQoL scores in patients with both non-radiographic and radiographic axSpA.

May 2024

The 1-year results of the SELECT-AXIS 2 study showed significant improvements in ASAS40 achievement in patients with nr-axSpA that were treated with upadacitinib 15mg QD versus placebo. Improvements in ASDAS endpoints, back pain, BASFI, and hsCRP from baseline were also observed.

Long-term clinical outcomes of certolizumab pegol treatment in non-radiographic axial spondyloarthritis stratified by baseline MRI and CRP status

RMD Open 2024;10:e003884 doi: 10.1136/rmdopen-2023-003884 https://pubmed.ncbi.nlm.nih.gov/38724259/

The safety follow-up extension of the C-axSpAnd trial showed that long-term clinical outcomes from certolizumab pegol treatment achieved after 1 year were generally sustained at 3 years across MRI+/CRP+, MRI−/CRP+ and MRI+/CRP− subgroups.