ARCALYST (rilonacept) is proven to treat recurrent pericarditis and significantly reduce the risk of pericarditis episodes
ARCALYST specifically targets interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β).1
Targeting these key cytokines addresses the underlying mechanism that drives inflammation in recurrent pericarditis.1
ARCALYST blocks IL-1 signaling by acting as a soluble decoy receptor that binds both IL-1α and IL-1β and prevents their interaction with cell surface receptors, thus disrupting the cycle of autoinflammation that drives recurrent pericarditis.
PHASE 3 RHAPSODY TRIAL
ARCALYST met the primary and all major secondary endpoints in the RHAPSODY pivotal trial.1,2
See below for the full design of the Phase 3, global, multicenter,
double-blind, placebo-controlled, randomized withdrawal trial
with an open-label extension.1,2
Initiation of ARCALYST and tapering of standard therapies
Assess time to treatment response and time to ARCALYST monotherapy
Treatment with ARCALYST or placebo
Assess reduction in risk of pericarditis recurrence
PRIMARY TRIAL ENDPOINT
Time to pericarditis recurrence
Major SECONDARY EFFICACY ENDPOINTS (week 16)
- Proportion of patients maintaining clinical response
- Percentage of days with no or minimal pericarditis pain
Long-term treatment with ARCALYST
Assess treatment up to 2 years
Key inclusion criteria at screening
A total of 86 patients (mean age 45 years [range 13-78], 57% females) with symptomatic pericarditis recurrence were enrolled and received trial treatment.1
Of these, 73 (85%) had a diagnosis of idiopathic pericarditis, the remainder being post cardiac injury. The mean duration of disease was 2.4 years with a mean number of 4.4 pericarditis events per year including the qualifying pericarditis event (0-10 point NRS ≥4 and CRP ≥1 mg/dL). Mean qualifying NRS pain score was 6.2, and mean qualifying CRP level was 6.2 mg/dL.1
REDUCTION IN RISK OF FUTURE FLARES
ARCALYST is proven to significantly reduce the risk of pericarditis recurrence.
The primary efficacy endpoint was time to first adjudicated pericarditis recurrence in the randomized withdrawal period.1
Only 7% (2 of 30) of patients treated with ARCALYST had a recurrence during the randomized withdrawal period.1
The median time to recurrence on ARCALYST could not be estimated due to the low number of recurrences.
The 2 pericarditis recurrences with ARCALYST occurred during temporary interruptions of 1 to 3 weekly doses of ARCALYST.
74% (23 of 31) of patients treated with placebo experienced a recurrence during the randomized withdrawal period.1
The median time to recurrence on placebo was 8.6 weeks (95% CI: 4.0, 11.7).
RESOLUTION OF EPISODES
ARCALYST is shown to provide rapid treatment response.
Secondary endpoints that were assessed during the run-in period.1
During the 12-week run-in period, 77 of 79 patients demonstrated a treatment response.*
• Median time to treatment response = 5.0 days (95% CI: 4.0, 7.0)
• Median time to ARCALYST monotherapy = 7.9 weeks
During the 12-week run-in period, patients also achieved symptom relief and reduction in inflammation.
• Median time to pain response = 5.0 days
• Median time to CRP normalization = 7.0 days
*Symptom relief or time to treatment response was defined as the time from the first dose to the first day when pericardial pain was NRS ≤2 and CRP ≤0.5 mg/dL (measured within 7 days before or after the pain response).
Patients treated with ARCALYST were able to
In the Phase 3 RHAPSODY trial run-in period, patients receiving corticosteroids at baseline were effectively transitioned to ARCALYST monotherapy.1,3
48% (41 of 86) of patients received corticosteroids at baseline.1
- Each patient treated with corticosteroids at baseline achieved clinical response with ARCALYST monotherapy
- None of the patients treated with corticosteroids at baseline and randomized to ARCALYST monotherapy experienced a recurrence while on therapy
Patients treated with ARCALYST experienced minimal or no pericarditis pain.1
Secondary efficacy endpoint was assessed during the randomized withdrawal period.1
of days with no pain
or minimal pain (NRS ≤2).1
Compared with 40% for patients on placebo (p<0.0001) at the secondary endpoint assessed at Week 16 of the randomized withdrawal period.
At week 16 of the randomized withdrawal period:
A majority (81%) maintained a clinical response measured at week 16 of the randomized withdrawal period compared with 20% for placebo (p=0.0002).
ARCALYST provides patients with a new choice.
treatment with ARCALYST in the long-term extension (LTE) trial.1,3