Publications

Burmester, et al. found that long-term filgotinib exposure was well tolerated in patients with moderate-to-severe active RA, with a stable rate of TEAEs over time. However, potential dose-dependent relationships for herpes zoster infections, malignancies and all-cause mortality were observed in patients aged ≥65 years, indicating the potential impact of age on the safety profile of Filgotinib. Therefore, some patients aged ≥65 years may benefit from the filgotinib 100 mg dose option.

Results of this analysis by Hernández-Cruz, et al. show that infections, herpes zoster and gastrointestinal AEs in patients with RA tended to be more frequent with JAKi treatment versus TNFi. They also found that treatment persistence was similar with JAKi and TNFi in patients with RA and axSpA, and only slightly higher for TNFi in patients with PsA.

Bimekizumab was well tolerated in patients with PsA and TNFi-IR up to 52 weeks, with a safety profile consistent with that observed in prior studies. This study aimed to assess 52-week safety and efficacy of bimekizumab in patients with active PsA and prior IR/intolerance to TNFi.

Therapeutic intervention during the at-risk phase of RA with abatacept is feasible, with acceptable safety profiles. However, the efficacy of intermittent administration at multiple intervals remains to be assessed.

Charles-Schoeman, et al. carried out a descriptive integrated analysis on patients with RA that were treated in the SELECT programme, with up to 6.5 years of exposure. They concluded that upadacitinib 15 mg QD had an acceptable safety profile, but long-term upadacitinib treatment was associated with dose-dependent laboratory abnormalities.

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

Data from this phase 3 RCT demonstrated that the efficacy of bimekizumab observed at 16 weeks remained consistent through to 52 weeks in the treatment of bDMARD-naïve patients with PsA. Patients who started the trial on placebo and switched to bimekizumab at week 16 showed similar improvements to those patients who were randomised to receive bimekizumab at the start of the trail. No new safety signals were identified.

In the UPJOINT open label study, the proportion of patients with PsA, and an inadequate response to csDMARDs or bDMARDs, who achieved minimal disease activity with upadacitinib was in line with the results of previous studies at 24 weeks. No new safety signals were identified.

Three-year data from the ixekizumab (IXE) COAST programme provide additional evidence that patients with axSpA receiving IXE experience long-term safety, and sustained improvements in efficacy outcomes, at 3 years.

The data gathered in this post-marketing surveillance study aligned with the previously established safety profile of tofacitinib, and reports were found to have consistent safety profiles in the treatment of both patient with PsA and RA. However, the results of this study should be interpreted considering the limitations of post-marketing surveillance studies.