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Product overview – Introducing Nucala
Nucala is in the benefits system with the following limitation: The product is only reimbursed for patients who have severe eosinophilic asthma that is inadequately controlled despite standard therapy and either oral corticosteroid therapy (OCS) at doses that cause an increased risk of adverse effects or in the presence of a contraindication to OCS therapy.
Nucala™ (mepolizumab) is the first targeted anti-interleukin (IL)-5 add-on therapy for your adult patients with severe refractory eosinophilic asthma. Information provided here can help you to determine if your patients are eligible for Nucala and learn about the safety profile of Nucala. You can also find key information about Nucala in the Top 10 facts section.
1. Nucala is the first targeted anti-IL-5 add-on therapy for your adult patients with severe refractory eosinophilic asthma
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patients.1
Nucala is a humanised monoclonal antibody that inhibits the bioactivity of IL-5. 1Nucala blocks the binding of IL-5 to the alpha chain of the IL-5 receptor complex on the eosinophil cell surface. This inhibits IL-5 signalling and reduces the production and survival of eosinophils. 23
Discover how Nucala blocks the binding of IL-5 – watch the mode of action animation
2. Identification of patients most likely to benefit from treatment with Nucala based on three criteria: 1
Current therapy – high-dose OCS* plus additional controller1
Exacerbation history – two or more exacerbations in the previous 12 months and/or daily OCS1
Blood eosinophil level – baseline blood eosinophils ≥150 cells/µL1**
Does your patient with severe asthma have severe refractory eosinophilic asthma? Click here for further information.
3. The MENSA study demonstrated that Nucala significantly reduced exacerbations by 53% compared with placebo, when both added to high dose ICS an additional maintenance treatment
Nucala added to high dose ICS and an additional maintenance treatment(s) reduced clinically significant exacerbations vs. placebo added to high dose ICS and an additional maintenance treatment(s) 4
Reduction in exacerbation frequency at Week 32 (MENSA primary endpoint) 4
Clinically significant exacerbations of asthma were defined as the worsening of asthma that required use of systemic corticosteroids or required hospitalisation and/or emergency department visits
Data from a 32-week, multicentre, randomised, double-blind, placebo-controlled, parallel group study comparing the efficacy and safety of Nucala 100mg SC vs. placebo vs. mepolizumab 75mg IV* (each added to high dose ICS and additional maintenance treatment(s), and administered once every four weeks) in patients with severe refractory eosinophilic asthma. The 75mg IV* mepolizumab treatment arm (n=191) is not represented in this graph. Nucala is licensed for SC use only. Rate of clinically significant exacerbations at Week 32 was a primary endpoint. Baseline values were similar for both treatment arms (placebo: 3.6/year, Nucala: 3.8/year). Rate of clinically significant exacerbations requiring hospitalisation (including intubation and admittance to an ICU), ED visits, change from baseline in FEV1, change from baseline in health-related quality of life (as measured by SGRQ), and patient and physician-rated global response to therapy were secondary or other study endpoints. 4
* An intravenous 75mg dose of Mepolizumab is an unlicensed investigational compound.
Learn more about exacerbation, quality of life, lung function and reduction in daily OCS use
4. Nucala significantly reduced exacerbations resulting in hospitalisation and/or emergency department (ED) visits 4
Nucala added to high dose ICS and an additional maintenance treatment(s) also significantly reduced exacerbations resulting in hospitalisations and/or emergency department (ED) visits vs. placebo added to high dose ICS and an additional maintenance treatment(s) by 61% ((0,08 vs 0,20 at week 32, pp=0,015) 4
*Unadjusted for multiple comparisons against placebo.
5. Nucala improved quality of life (SGRQ) by 7.0 units 4
Nucala added to high dose ICS and an additional maintenance treatment(s) improved* health-related quality of life (measured using St. George’s Respiratory Questionnaire [SGRQ]) vs. placebo and an additional maintenance treatment(s) 4
Improvement in SGRQ total score from baseline at Week 32 (MENSA secondary endpoint) 4
The St. George’s Respiratory Questionnaire (SGRQ) is a validated disease-specific health status assessment for use in asthma and COPD and a difference of ≥4.0 units is considered clinically meaningful. 56
*The improvement in SGRQ is clinically meaningful, however statistical significance cannot be inferred due to the hierarchical ‘gatekeeping’ approach used. The p-values provided are unadjusted for multiple comparisons.
Data from a 32-week, multicentre, randomised, double-blind, placebo-controlled, parallel group study comparing the efficacy and safety of Nucala 100mg SC vs. placebo vs. mepolizumab 75mg IV (each added to high dose ICS and additional maintenance treatment(s), and administered once every four weeks) in patients with severe refractory eosinophilic asthma. The 75mg IV† mepolizumab treatment arm (n=191) is not represented in this graph. Nucala is licensed for SC use only. Mean change from baseline in St. George’s Respiratory Questionnaire at Week 32. Mean baseline values were similar for both treatment arms (placebo: 46.9 units, Nucala: 47.9 units). 4
† An intravenous 75mg dose of Mepolizumab is an unlicensed investigational compound.
Learn more about exacerbation, quality of life, lung function and reduction in daily OCS use
6. Nucala improved lung function by 98mL (statistical significance cannot be inferred due to the hierarchical ‘gatekeeping’ approach used.) 4
Nucala added to high dose ICS and an additional maintenance treatment(s) improved lung function* (as measured by pre-bronchodilator FEV1) vs. placebo added to high dose ICS and an additional maintenance treatment(s) (placebo: 1860mL, Nucala: 1730mL ; p<0.001*). 4
Improvement in lung function from baseline at Week 32 (MENSA secondary endpoint) 4
*The improvement in lung function is clinically meaningful; The p-values provided are unadjusted for multiple comparisons.
Data from a 32-week, multicentre, randomised, double-blind, placebo-controlled, parallel group study comparing the efficacy and safety of Nucala 100mg SC vs. placebo vs. mepolizumab 75mg IV (each added to high dose ICS and additional maintenance treatment(s), and administered once every four weeks) in patients with severe refractory eosinophilic asthma. The 75mg IV† mepolizumab treatment arm (n=191) is not represented in this graph. Nucala is licensed for SC use in adult patients only. Change in pre-bronchodilator FEV1 at Week 32 was a secondary efficacy endpoint. Baseline values for 100mg SC Nucala were slightly lower at baseline (placebo: 1860mL, Nucala: 1730mL). 4
† An intravenous 75mg dose of Mepolizumab is an unlicensed investigational compound.
Learn more about exacerbation, quality of life, lung function and reduction in daily OCS use
7. In the SIRIUS study, Nucala resulted in a reduction in daily OCS dose as a primary endpoint while maintaining symptom control
Median OCS dose at baseline (during optimisation phase) was 10mg for Nucala (n=69) and 12.5mg for placebo (n=66) 7
- 54% (37/69) of Nucala patients achieved at least a 50% reduction in the daily OCS dose compared with 33% (22/66) of patients receiving placebo, when both were added to high dose ICS and an additional maintenance treatment(s) (p=0.03) 9
- 54% (37/69) of Nucala patients achieved a reduction in the daily OCS dose to ≤5mg compared with 32% (21/66) of subjects receiving placebo, when both were added to high dose ICS and an additional maintenance treatment(s) (p=0.02) 7
- The median percentage reduction in daily OCS dose was 50% in the Nucala group, compared with 0% in the placebo group (secondary endpoint, p=0.007) 7
In the Nucala group, 14% (10/69) of patients achieved a total cessation of OCS dose compared with 8% (5/66) in the placebo group. This was an additional secondary endpoint (p=ns) 7
8. Nucala reduced eosinophil levels by 84% vs. placebo
Nucala added to high dose ICS and an additional maintenance treatment(s) reduced blood eosinophil levels by 84% without complete deletion (290 cells/microl at baseline vs 40 cells/microl at week 32 (N=182)) at Week 32 compared with placebo when both were added to high dose ICS and an additional maintenance treatment(s), in patients with severe refractory eosinophilic asthma 1
Data from a 32-week, multicentre, randomised, double-blind, placebo-controlled, parallel group study comparing the efficacy and safety of Nucala 100mg SC vs. placebo vs. mepolizumab 75mg IV* (each added to high dose ICS and an additional maintenance treatment(s), and administered once every four weeks) in patients with severe refractory eosinophilic asthma. Nucala is licensed for SC use only. 4
*An intravenous 75mg dose of Mepolizumab is an unlicensed investigational compound.
9. In both efficacy studies, the incidences of adverse events and serious adverse events with Nucala were found to be similar to placebo when both were added to high dose ICS and additional maintenance treatment(s) (8% for Nucala, 3% for placebo) 1
A total of 915 subjects with severe refractory eosinophilic asthma have received either a subcutaneous or an intravenous dose of Nucala during clinical studies of 24 to 52 weeks duration. Injection site reactions were more common in the Nucala 100mg SC group compared with placebo (8% vs. 3%) 1
The most common symptoms associated with subcutaneous injections included: pain, erythema, swelling, itching, and burning sensation. Injection site reactions occurred mainly at the start of treatment and within the first 3 injections with fewer reports on subsequent injections. 1Nucala is licensed for SC use in adult patients only.
10. Nucala is administered every 4 weeks as a fixed dose SC injection 1
- Single SC injection to the upper arm, thigh or abdomen, administered once every 4 weeks
- Fixed dose of (1.0mL), independent of weight
- Administered by a healthcare professional
** (Nt council recommendation: 4 or more exacerbations/year and >300 cells/mikrol, maintenance treatment with OCS or when OCS is not considered suitable)
ICS, inhaled corticosteroid; OCS, oral corticosteroid
*For patients 6-11 taking medium- to high-dose ICS + additional controller.
†Exacerbations defined as worsening of asthma requiring OCS and/or hospitalization and/or ED visits; for patients ≥ 12 years on maintenance OCS, exacerbations defined as at least doubling the existing maintenance dose for ≥3 days.
References:
- Nucala SmPC.
- Rosenberg HF et al. J Allergy Clin Immunol 2007; 119: 1303–1310.
- Ortega H. Eur Respir J 2014; 44:239–241.
- Ortega H et al. N Engl J Med 2014; 371:1198–1207.
- Jones PW. Eur Resp J 2002; 19:398–404.
- Jones P et al. Am Rev Respir Dis 1992; 145:1321–1327.
- Bel E et al. N Engl J Med 2014; 371:1189–1197.
Nucala is a trademark of the GSK group of companies.
NUCALA (mepolizumab), 100 mg pulver till injektionsvätska, lösning, 100 mg injektionsvätska, lösning i förfylld spruta, 100 mg injektionsvätska, lösning i förfylld penna, 40 mg injektionsvätska, lösning i förfylld spruta. Medel vid obstruktiva luftvägssjukdomar, övriga systemiska medel för obstruktiva lungsjukdomar Rx (F), ATC kod: R03DX09
Terapeutiska indikationer: Nucala är indicerat som tilläggsbehandling vid svår refraktär eosinofil astma hos vuxna patienter, ungdomar och barn från 6 års ålder. Nucala är avsett som tilläggsbehandling till intranasala kortikosteroider för behandling av vuxna patienter med svår CRSwNP, som inte uppnår tillräcklig sjukdomskontroll med systemiska kortikosteroider och/eller kirurgi. Nucala är avsett som tilläggsbehandling till patienter från 6 års ålder med remitterande eller refraktär eosinofil granulomatös polyangit (EGPA). Nucala är avsett som tilläggsbehandling för vuxna patienter med otillräckligt kontrollerat hypereosinofilt syndrom (HES) utan identifierbar icke-hematologisk sekundär orsak.
Ytterligare information: I kliniska studier visades effekt hos följande subpopulation: aktuell standardbehandling som minst inkluderade högdosbehandling med inhalerade kortikosteroider (ICS) plus ytterligare en underhållsbehandling, två eller fler exacerbationer under de senaste 12 månaderna eller beroende av systemiska kortikosteroider samt blodeosinofilvärde minst 150 celler/μl vid behandlingsstart eller minst 300 celler/μl under de senaste 12 månaderna
Kontraindikationer: Överkänslighet mot den aktiva substansen eller mot något hjälpämne
Varningar och försiktighet: För att underlätta spårbarheten av biologiska läkemedel ska den administrerade produktens namn och batchnummer tydligt anges i patientjournalen. Mepolizumab ska inte användas för att behandla akuta astmaexacerbationer. Astmarelaterade biverkningar eller exacerbationer kan förekomma under behandling. Abrupt utsättning av kortikosteroider efter behandlingsstart med mepolizumab rekommenderas ej. Akuta och fördröjda systemiska reaktioner, inklusive överkänslighetsreaktioner (t.ex. anafylaxi, urtikaria, angioödem, hudutslag, bronkospasm, hypotoni), har förekommit efter administrering av mepolizumab. Patienter med befintliga maskinfektioner ska behandlas innan behandling med mepolizumab påbörjas. Om patienten blir infekterad under behandling med Nucala och inte svarar på maskmedel ska temporär utsättning av Nucala övervägas. Nucala har inte studerats hos patienter med organ- eller livshotande symtom av HES eller EGPA.
Graviditet: Som en försiktighetsåtgärd bör man undvika användningen av Nucala under graviditet. Administrering av Nucala till gravida kvinnor ska endast övervägas om den förväntade fördelen för modern är större än den eventuella risken för fostret.
Subventionsbegränsning: Subventioneras endast för patienter med svår eosinofil astma som är otillräckligt kontrollerade trots standardbehandling och antingen behandling med perorala kortikosteroider (OCS) i doser som ger ökad risk för biverkningar eller när OCS är kontraindicerat.
För fullständig förskrivningsinformation och pris, se www.fass.se.
Datum för översyn av produktresumén: 2022-10-11
GlaxoSmithKline AB, Box 516, 169 29 Solna. Tel 08-638 93 00, www.se.gsk.com.
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Om du vill rapportera en biverkning på något av våra läkemedel eller vacciner så kan du kontakta oss på följande sätt: Webformulär: se.gsk.com/biverkning. Telefon: 08-638 93 00 (be om att bli kopplad till Biverkningsenheten)
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Om du vill rapportera en biverkning på något av våra läkemedel eller vacciner så kan du kontakta oss på följande sätt: Rapportera en biverkning via webbformulär eller via telefon på 08-638 93 00 (be om att bli kopplad till Biverkningsenheten)
