The latest developments in rheumatology highlight advancements in the treatment of psoriatic arthritis (PsA), improved clinical decision-making for gout, and new insights into fibromyalgia. This includes new data supporting the use of secukinumab for PsA, studies examining clinical decision making for clinicians treating gout, and the role of sleep in fibromyalgia.
Secukinumab's Efficacy in Psoriatic Arthritis
New research indicates that secukinumab and adalimumab, both effective treatments for PsA, have distinct advantages. A prospective cohort study involving 116 participants revealed no significant difference in ACR20 response between the two drugs at week 12. However, secukinumab demonstrated superior efficacy in achieving Psoriasis Area and Severity Index (PASI)90 (OR, 2.25; 95% CI, 1.07 – 3.74; P = .03), indicating its suitability for patients with severe skin involvement. Adalimumab, on the other hand, showed better improvement in ultrasound synovitis count (β: 0.94, 95% CI: 0.09 – 1.79, P = .03) and synovitis PD signal (β: 0.20, 95% CI: 0.03 – 0.36, P = .02).
Furthermore, the Phase 3 INVIGORATE-2 study demonstrated the benefits of intravenous (IV) secukinumab for rapid improvement of disease signs and symptoms in patients with active PsA. The study, which was placebo-controlled, showed that all primary and secondary efficacy endpoints for secukinumab achieved statistical significance (all adjusted P <.05). A significantly greater proportion of patients receiving IV secukinumab achieved the primary endpoint of ACR50 response rates at Week 16 compared with placebo (31.4% vs. 6.3%; adjusted P <.0001).
Improving Gout Clinical Decision Making
Research is also focused on improving clinical decision-making in gout management. A simplified gout remission definition was found to be a feasible and valid option when compared with the 2016 preliminary gout remission definition in a study of nurse-led and usual (general practitioner) care. Participants in the nurse-led care group were more likely to achieve remission using either definition at year 2 compared with the group receiving usual care. Participants that achieved remission according to either definition had better gout outcomes via the GIS, including greater control over their gout, worry about future gout attacks, gout disease progression and its interference in future activities, and efficacy of gout medication, than those who did not.
In addition, a radiomics model was developed to distinguish patients with and without gout flares, potentially facilitating the clinical decision-making process. The model, using 4 radiomic features, achieved an area under the receiver operating characteristic curve (AUC) of 0.76 (95% CI, 0.69-0.83). The comprehensive model, which included clinical data, had an AUC of 0.79 (95% CI, 0.73-0.86), with differentiated values agreeing well with actual values as seen on calibration curves (P >.05).
Fibromyalgia and Sleep Issues
Tonix Pharmaceuticals has submitted a new drug application (NDA) for TNX-102 SL, a non-opioid, centrally acting analgesic for the proposed treatment of fibromyalgia. TNX-102 SL, a cyclobenzaprine hydrochloric acid sublingual tablet, targets non-restorative sleep, a characteristic of fibromyalgia. The NDA submission is supported by the phase 3 RELIEF trial that met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (P = .010) and the phase 3 RESILIENT trial that also met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (P. = .00005).
However, a retrospective cohort analysis has found that patients with fibromyalgia who continue opioid use beyond 90 days are at significantly greater risk of developing depression or a sleep disorder. Adjusted analyses showed that long-term opioid use was linked to a 58% increased risk of depression (hazard ratio [HR], 1.58; 95% CI, 1.29 – 1.95) and 30% increased risk of sleep disorders (HR, 1.30; 95% CI, 1.09 – 1.55).
