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Nucala▼: help prevent repeat nasal polyps surgery2,3

Are you looking for an alternative to repeat surgery for your patients with nasal polyps?

In patients with eosinophil levels of 300 cells/μL or above, Nucala▼ reduced the need for surgery by up to 69% vs. placebo at Week 52 (HR: 0.31, CI: 0.15, 0.64).3

Nucala▼ helps prevent repeat nasal polyps surgery.2,3

Nucala▼ addresses an unmet need in the treatment of nasal polyps, providing an alternative to repeat surgery1 and benefitting patients with the most severe form* of nasal polyps.2 All SYNAPSE participants suffered from recurrent nasal polyps, following at least one prior surgery.2

SYNAPSE: Both co-primary endpoints were met: median change in total endoscopic nasal polyps score† at Week 52, Nucala▼ (n=206): -1.0, placebo (n=201): 0.0 (p<0.0001); median change in mean nasal obstruction VAS score during Weeks 49–52, Nucala▼ (n=206): -4.41, placebo (n=201): -0.82 (p<0.0001)2‡

  • In patients with refractory-to-treatment nasal polyps (study population, n=407): 57% reduction in need for surgery with Nucala▼ vs. placebo.2§
    • Secondary endpoint: time to nasal polyps surgery; results at Week 52, HR: 0.43, 95% CI: 0.25, 0.76; p=0.0032. Nucala▼: n=18/206; placebo: n=46/2012
  • In patients with refractory-to-treatment nasal polyps with 300 eosinophils/μL or more (n=278): up to 69% reduction in need for surgery with Nucala▼ vs. placebo.3¶
    • Post hoc analysis: results at Week 52: HR: 0.31, CI: 0.15, 0.64. Nucala▼: n=10/139 vs. placebo: n=35/139.3
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Nucala▼ helps prevent repeat nasal polyps surgery.2,3

  • Nucala▼ benefitted patients with the most severe form* of nasal polyps, who had a history of at least one prior surgery.2‡
  • Nucala▼ reduced the need for surgery by 57% vs. placebo in patients with nasal polyps (study population, n=407; HR: 0.43, 95% CI: 0.25, 0.76).2§
  • In patients with nasal polyps with 300 eosinophils/μL or more, Nucala▼ reduced the need for surgery by up to 69% vs. placebo (n=278; HR: 0.31, CI: 0.15, 0.64).3¶

Help prevent repeat nasal polyps surgery with Nucala▼2,3

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Nucala▼ (pre-filled pen, pre-filled syringe) Safety Information

SAFETY

Contraindications

Hypersensitivity to mepolizumab or to any of the excipients.

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA▼. These reactions generally occur within hours of administration, but in some instances can have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, NUCALA▼ should be discontinued.

Acute Asthma Symptoms or Deteriorating Disease

NUCALA▼ should not be used to treat acute asthma symptoms or acute exacerbations. Do not use NUCALA▼ to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with NUCALA▼.

Opportunistic Infections: Herpes Zoster

Herpes zoster has occurred in subjects receiving NUCALA▼ 100 mg in controlled clinical trials. Consider vaccination if medically appropriate.

Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with NUCALA▼. Reductions in corticosteroid dosage, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

Eosinophils may be involved in the immunological response to some helminth infections. Patients with known parasitic infections were excluded from participation in clinical trials. It is unknown if NUCALA▼ will influence a patient’s response against parasitic infections. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA▼. If patients become infected while receiving treatment with NUCALA▼ and do not respond to anti helminth treatment, discontinue treatment with NUCALA▼ until infection resolves.

Adverse Reactions

Adverse reactions that occurred in ≥ 3% of NUCALA▼-treated patients and more frequently than in patients treated with placebo in the CRSwNP trial: oropharyngeal pain, arthralgia, abdominal pain, upper, diarrhea, pyrexia, nasal dryness, rash.
Adverse reactions with NUCALA▼ with ≥3% incidence and more common than placebo in patients with severe asthma (in the 2 confirmatory efficacy and safety trials): headache, injection site reaction, back pain, fatigue, influenza, urinary tract infection, abdominal pain upper, pruritus, eczema, muscle spasms.

Footnotes

*Defined by bilateral nasal polyps symptoms (nasal obstruction symptom visual analogue scale [VAS] score of >5 [maximum 10]) and eligible for repeat nasal surgery (overall symptoms VAS score >7 and endoscopic nasal polyps score of ≥5 [maximum 8], with a minimum score of 2 in each nasal cavity).2
†Total endoscopic nasal polyps score was centrally read.4

‡SYNAPSE is a 52-week, randomised, double-blind, parallel group Phase III study assessing the clinical efficacy and safety of Nucala▼ 100mg SC as an add-on to maintenance treatment in adults with severe bilateral nasal polyps, compared to placebo.2
§Need for surgery based on time to nasal polyps surgery. Secondary endpoint: time to first nasal polyps surgery within the study. At Week 52, 18/206 (9%) participants treated with Nucala▼ had had surgery vs. 46/201 (23%) with placebo. For the purpose of this study, nasal polyps surgery was defined as any procedure involving instruments resulting in incision and removal of tissue or dilation of the air passages in the nasal cavity.2
Post hoc subgroup analysis in participants with ≥300 cells/μL. At Week 52, 10/139 (7%) participants treated with Nucala▼ had had surgery vs. 35/139 (25%) with placebo.3

Abbreviations

CI, confidence interval; HR, hazard ratio; ICS, inhaled corticosteroids; SC, subcutaneously; VAS, visual analogue scale.

References

  1. Bachert C, Holtappels G. Pathophysiology of chronic rhinosinusitis, pharmaceutical therapy options. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2015;14:Doc09.
  2. Han JK, Bachert C, Fokkens W et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021; published online April 16.
  3. Bachert C, Sousa AR, Han J et al. Mepolizumab for Chronic Rhinosinusitis With Nasal Polyps: Comorbid Asthma, NSAID Exacerbated Respiratory Disease, Eosinophil Stratification. ACAAI 2020. Poster no. P503.
  4. GlaxoSmithKline. SYNAPSE Study Data. Data on File: 2020N442969_00. REF-123390.

For more information, please refer to the prescribing information or contact GlaxoSmithKline via P.O Box 55850, Jeddah, 21544, Kingdom of Saudi Arabia. Telephone: +966 12 653 6666 or via gcc.medinfo@gsk.com
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▼ This medicine is subjected to additional monitoring. This will allow quick identification of new safety information.
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PM-SA-MPL-WCNT-240002 October 2024