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Data on pruritus & fatigue

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Data on reduction of pruritus with IQIRVO1

IQIRVO was studied in patients with PBC with moderate-to-severe pruritus, defined as a PBC WI-NRS score ≥4. The change in pruritus from baseline through weeks 24 and 52 were secondary endpoints of the study1

Results with IQIRVO presented below were not statistically significant and, therefore, these results are descriptive only.1

A trend toward improving pruritus was observed with IQIRVO, as measured by WI-NRS (LS mean change from baseline -1.93 vs -1.15 with UDCA alone; 95% CI: -2.0 to 0.4).1

Pruritus impact vs UDCA alone was measured by PBC-40 and 5-D itch scales1,a

PBC-40 itch domain at week 521

PBC-40 itch domain bar graph PBC-40 itch domain bar graph

The PBC-40 is a patient-derived measure validated for PBC, covering 6 domains: fatigue, pruritus, cognitive, emotional, social, and other symptoms.2

A 0.5-point change per question in the itch domain was a threshold for response, with ≥1.5 change being clinically meaningful.2,3

5-D itch score at week 521

IQIRVO 5-D itch score bar graph IQIRVO 5-D itch score bar graph

The 5-D itch scale is a patient-reported measure of the degree, duration, direction, disability, and distribution of pruritus.4

aSix patients in the IQIRVO group took IQIRVO alone, while 2 patients in the UDCA group took placebo alone.5

Data on reduction 
of fatigue with IQIRVO6

Patients on IQIRVO with moderate-to-severe fatigue reported improvement over time6

An analysis of fatigue via the PRO Measurement Information System (PROMIS) Fatigue Short Form 7a (PROMIS fatigue) and PBC-40 fatigue domain was performed. This was conducted during the ELATIVE® double-blind period and in IQIRVO-treated patients who completed the double-blind period and entered the OLE.6

Decreases observed in PROMIS fatigue and PBC-40 fatigue domain scores in patients with moderate-to-severe fatigue at baseline6

Data are reported for patients with valid fatigue data at baseline and at week 52 and for the subgroup of patients with moderate-to-severe fatigue at baseline (defined as PROMIS fatigue score ≥60 or PBC-40 fatigue domain score ≥29).6 No formal statistical analysis was conducted and results are descriptive only.

IQIRVO PROMIS fatigue and PBC-40 line charts showing domain scores from baseline to week 52 IQIRVO PROMIS fatigue and PBC-40 line charts showing domain scores from baseline to week 52

Additional PROMIS fatigue and PBC 40 fatigue data from the OLE at weeks 104 and 1306

Changes in fatigue were summarized from baseline to week 104 and week 130 with respect to available MCID, categorical changes, and mean change from baseline in total score.6

The data are from a single arm of the OLE study, including only patients on IQIRVO during ELATIVE. No formal statistical analysis was conducted and results are descriptive only.

Mean change from baseline in total scores of the PROMIS fatigue and PBC-40 fatigue domain6,b

IQIRVO PROMIS fatigue chart IQIRVO PROMIS fatigue chart
IQIRVO PBC-40 fatigue chart IQIRVO PBC-40 fatigue chart

bPatients included are those with non-missing data at baseline and each time point of interest. Moderate-to-severe fatigue was defined as a PROMIS fatigue total score ≥60 or PBC-40 fatigue domain total score ≥29 at baseline. Week 52: n=95, week 104: n=48, week 130: n=26. Dotted lines reflect MCID for each measure.6

See the safety and tolerability of IQIRVO

CI=confidence interval; LS=least squares; MCID=minimal clinically important difference; OLE=open-label extension; PBC=primary biliary cholangitis; UDCA=ursodeoxycholic acid; WI-NRS=worst itch numeric rating scale.

References: 1. Kowdley KV, Bowlus CL, Levy C, et al; ELATIVE Study Investigators’ Group. Efficacy and safety of elafibranor in primary biliary cholangitis. N Engl J Med. 2024;390(9):795-805, suppl. 2. Jacoby A, Rannard A, Buck D, et al. Development, validation, and evaluation of the PBC-40, a disease specific health related quality of life measure for primary biliary cirrhosis. Gut. 2005;54(11):1622-1629. 3. Jones D, Carbone M, Invernizzi P, et al. Impact of setanaxib on quality of life outcomes in primary biliary cholangitis in a phase 2 randomized controlled trial. Hepatol Commun. 2023;7(3):e0057. 4. Elman S, Hynan LS, Gabriel V, et al. The 5-D itch scale: a new measure of pruritus. Br J Dermatol. 2010;162(3):587-593. 5. IQIRVO [package insert]. Ipsen Biopharmaceuticals, Inc. Cambridge, MA. 6. Data on file. Ipsen Biopharmaceuticals, Inc.

Indication and Important Safety Information

Indication

IQIRVO® is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Limitations of Use

Use of IQIRVO is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

Important Safety Information

Myalgia, Myopathy, and Rhabdomyolysis: Rhabdomyolysis resulting in acute kidney injury occurred in one IQIRVO-treated patient who had cirrhosis at baseline and was also taking a stable dose of an HMG-CoA reductase inhibitor (statin). Myalgia or myopathy, with or without CPK elevations, occurred in patients treated with IQIRVO alone or treated concomitantly with a stable dose of an HMG-CoA reductase inhibitor. Assess for myalgia and myopathy prior to IQIRVO initiation. Consider periodic assessment (clinical exam, CPK measurement) during treatment with IQIRVO, especially in those who have signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain, or myopathy, or rhabdomyolysis.

Fractures: Fractures occurred in 6% of IQIRVO-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with IQIRVO and monitor bone health according to current standards of care.

Adverse Effects on Fetal and Newborn Development: IQIRVO may cause fetal harm when administered during pregnancy. For females of reproductive potential, verify that the patient is not pregnant prior to initiation of therapy. Advise females of reproductive potential to use effective non-hormonal contraceptives or add a barrier method when using systemic hormonal contraceptives during treatment with IQIRVO and for 3 weeks following the last dose of IQIRVO.

Drug-Induced Liver Injury: Drug-induced liver injury occurred in one patient who took IQIRVO 80 mg once daily and two patients who took IQIRVO at 1.5-times the recommended dosage, of which one presented with autoimmune-like hepatitis. The median time to onset of elevation in liver tests was 85 days. Obtain baseline clinical and laboratory assessments at treatment initiation with IQIRVO and monitor thereafter according to routine patient management. Interrupt IQIRVO treatment if liver tests (ALT, AST, total bilirubin [TB], and/or alkaline phosphatase [ALP]) worsen, or the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting IQIRVO.

Hypersensitivity Reactions: Hypersensitivity reactions have occurred in a clinical trial with IQIRVO at 1.5-times the recommended dosage. Three patients (0.2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation. Hypersensitivity reactions resolved after discontinuation of IQIRVO and treatment with steroids and/or antihistamines. If a severe hypersensitivity reaction occurs, permanently discontinue IQIRVO. If a mild or moderate hypersensitivity reaction occurs, interrupt IQIRVO and treat promptly. Monitor the patient until signs and symptoms resolve. If a hypersensitivity reaction recurs after IQIRVO rechallenge, then permanently discontinue IQIRVO.

Biliary Obstruction: Avoid use of IQIRVO in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt IQIRVO and treat as clinically indicated.

Drug-Drug Interactions

IQIRVO may reduce the systemic exposure of progestin and ethinyl estradiol (CYP3A4 substrates), which may lead to contraceptive failure and/or an increase in breakthrough bleeding. Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after last dose.

CPK elevation and/or myalgia occurred in patients on IQIRVO monotherapy. Co-administration of IQIRVO and HMG-CoA reductase inhibitors can increase the risk of myopathy. Monitor for signs and symptoms of muscle injury. Consider periodic assessment (clinical exam, CPK) during treatment. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain or myopathy.

Co-administration of IQIRVO with rifampin, an inducer of metabolizing enzymes, may reduce the systemic exposure of elafibranor resulting in delayed or suboptimal biochemical response. Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during treatment with IQIRVO.

Bile acid sequestrants may interfere with IQIRVO absorption and systemic exposure, which may reduce efficacy. Administer IQIRVO at least 4 hours before or after a bile acid sequestrant, or at as great an interval as possible.

Use in Special Populations

Pregnancy: Based on data from animal reproduction studies, IQIRVO may cause fetal harm when administered during pregnancy. There are insufficient data from human pregnancies exposed to IQIRVO to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Ipsen Biopharmaceuticals, Inc. adverse event reporting line at 1-855-463-5127 or https://www.ipsen.com/contact-us/.

Lactation: There are no data available on the presence of IQIRVO or its metabolites in human milk, or on effects of the drug on the breastfed infant or the effects on milk production. IQIRVO is not recommended during breastfeeding and for at least 3 weeks following last dose of IQIRVO because the risk to breastfed child cannot be excluded.

Females and Males of Reproductive Potential: IQIRVO may cause fetal harm when administered to pregnant women. Verify the pregnancy status of females of reproductive potential prior to initiating IQIRVO. Advise females of reproductive potential to use effective contraception during treatment with IQIRVO and for 3 weeks after the final dose.

The most common adverse events occurring in ≥10% of patients were weight gain (23%), abdominal pain (11%), nausea (11%), vomiting (11%), and diarrhea (11%).

You are encouraged to report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127.

Please see full Prescribing Information for IQIRVO.