research reports have confirmed that in patients with active of psoriatic
arthritis , guselkumab 100mg Q4W or Q8W
led to clinically meaningful and sustained improvements in fatigue through 1 year.
The findings have been published in Arthritis Research & Therapy.
(Janssen Biotech, Horsham, PA, USA), a high-affinity, human monoclonal antibody
specific to the interleukin (IL)-23p19-subunit, is approved to treat patients
with moderate-to-severe psoriasis and active PsA.It is well documented that the
interleukin-23p19-subunit inhibitor guselkumab effectively treats signs and
symptoms of psoriatic arthritis (PsA).With this background,a team of researchers evaluated the effect of guselkumab
the study protocol, across two phase 3 trials of guselkumab (DISCOVER-1,
DISCOVER-2), patients with active PsA despite standard therapy were randomized
to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W, N = 373);
guselkumab 100 mg at week 0, week 4, and then Q8W (N = 375); or placebo (N =
372) through week 24, after which patients in the placebo group crossed over to
guselkumab Q4W. Fatigue was measured as a secondary endpoint using the
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument
(range 0–52, higher scores indicate less fatigue). Mediation analysis was used
to adjust for indirect effects on fatigue deriving from improvement in other
outcomes, including ≥20% improvement in American College of Rheumatology
criteria (ACR20; prespecified), minimal disease activity (MDA; post hoc), or
C-reactive protein (CRP; post hoc).
highlighted some key facts.
- Baseline mean (SD) FACIT-Fatigue scores
in DISCOVER-1 (N = 381) and DISCOVER-2 (N = 739), ranging from 29.1 (9.5) to
31.4 (10.1), indicated substantial levels of fatigue relative to the United
States general population (43.6 [9.4]).
- Across studies, mean improvements, and
proportions of patients with ≥4-point improvements, in FACIT-Fatigue scores at
week 24 with guselkumab Q4W and Q8W (5.6–7.6 and 54–63%, respectively) were
larger vs placebo (2.2–3.6 and 35–46%).
- Improvement in FACIT-Fatigue scores with
guselkumab was sustained from week 24 to week 52, with moderate-to-large effect
sizes (Cohen’s d = 0.52–0.81 at week 24; 0.66–0.91 at week 52).
- Mediation analyses demonstrated that
substantial proportions of the effects of guselkumab vs placebo on fatigue were
direct effect, after adjusting for achievement of ACR20 (Q4W 69–70%, Q8W 12–36%
direct effect) or MDA (72–92% across dosing regimens) response or for change in
serum CRP concentrations (82–88% across dosing regimens).
the results, the team concluded that, “Taken together, results of these
analyses indicate a strong impact of guselkumab on the fatigue of PsA when
assessed via the FACIT-Fatigue instrument. Although further research is needed
to more fully characterize the mechanism by which guselkumab improves patient
fatigue, our findings may further inform treatment decisions, additional
research on this topic, and future consensus deliberations surrounding PsA core
full article follow the link: https://doi.org/10.1186/s13075-021-02554-3
Source: Arthritis Research &