About Somavert

Indicated for the treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-I concentrations or was not tolerated

Somavert normalises IGF-I in a unique way1

Somavert mechanism of action
Somavert works on cell surfaces around the body, directly targeting and blocking growth hormone receptors to inhibit IGF-I production with a high predictability1-3

 

 

Somavert can help achieve high rates of IGF-I normalisation1,3

Somavert IGF-I normalisation rates at 12 weeks and 12 months
Schematic showing proportion of patients with normal IGF-I levels progressing through pivotal clinical trials
Somavert’s tumour-independent mechanism of action may explain how it can achieve IGF-I normalisation rates of up to 97% when appropriately titrated (n=90, p<0.05)3

*p=0.02. **p<0.001. Maximum recommended dose of Somavert should not exceed 30 mg daily.1

 

Somavert seeks to minimise the impact of acromegaly on quality of life

Somavert symptom score reductions at 6 months
Bar graph showing impact of treatment on various symptoms of acromegaly
Patients on Somavert report significant reductions versus baseline in soft tissue swelling, headache, joint pain and general physical condition, and total signs and symptoms score‡1,5

‡Total signs and symptoms score reduction observed at 12 weeks (p<0.05, n=112).1

 

 

References

  1. Somavert Summary of Product Characteristics. July 2020. Available at https://www.medicines.org.uk/emc/medicine/14353 (last accessed August 2020).
  2. Sherlock M, et al. Medical therapy in acromegaly. Nat Rev Endocrinol 2011;7:291–300.
  3. van der Lely AJ, et al. Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist. Lancet 2001;24;358(9295):1754–9.
  4. Trainer PJ, et al. Treatment of acromegaly with the growth hormone-receptor antagonist pegvisomant. N Engl J Med 2000;342(16):1171–7.
  5. Schreiber I, et al. Treatment of acromegaly with the GH receptor antagonist pegvisomant in clinical practice: Safety and efficacy evaluation from the German Pegvisomant Observational Study. Eur J Endocrinol 2007;156:75–82.

PP-SOM-GBR-0631. August 2020.

Somavert has an established safety and tolerability profile1–3

Somavert safety profile
Image of body showing areas impacted by adverse events
Over 2000 patients have participated in ACROSTUDY, the global safety surveillance study for Somavert to date, giving us a wealth of information about possible adverse events1,2

 

Monitoring of liver tests

Liver function should be monitored at baseline and every 4–6 weeks on treatment, and more frequently if elevations are detected1

 

 

 

References

  1. Somavert Summary of Product Characteristics. July 2020. Available at https://www.medicines.org.uk/emc/medicine/14353 (last accessed August 2020).
  2. ACROSTUDY data on file. Final study report. November 2018.
  3. Buchfelder M, et al. Long-term treatment with pegvisomant: observations from 2090 acromegaly patients in ACROSTUDY. Eur J Endocrinol, 2018;179(6):419–27.

PP-SOM-GBR-0631. August 2020.

The majority of pituitary tumours remain stable with Somavert1

  • Although Somavert does not directly act on the pituitary tumour, 96.3% of patients experience maintained or decreased tumour size while on Somavert*1
  • Treatment-resistant tumour progression occurs in a small minority of patients with acromegaly, regardless of treatment modality2
  • When no tumour growth is observed in the first 18 months of treatment with Somavert, it is unlikely that any growth will occur subsequently3

 *As assessed by local ± central MRI analysis.

Tumour stability during ACROSTUDY1,4 
Image of purple people and blue people to denote the proportion of safety surveillance study participants who experienced tumour progression

 

 

 

References

  1. ACROSTUDY data on file. Final study report. November 2018.
  2. Besser GM et al. Predictors and rates of treatment-resistant tumor growth in acromegaly. Eur J Endocrinol 2005;153:187–93.
  3. Jiminez et al., Follow-up of pituitary tumour volume in patients with acromegaly treated with pegvisomant in clinical trials. European Journal of Endocrinology 2008: 159(5): 517–23.
  4. Buchfelder M, et al. Long-term treatment with pegvisomant: observations from 2090 acromegaly patients in ACROSTUDY. Eur J Endocrinol, 2018;179(6):419–27.

PP-SOM-GBR-0631. August 2020.

Somavert both directly and indirectly impacts common acromegaly comorbidities

Glucose homeostasis significantly improved versus baseline1,2White blood glucose monitoring icon

-1.4 mmol/L fasting plasma glucose reduction, -0.4% HbA1c reduction versus baseline at 8 months, n=52, p≤0.0011

 

CV risk significantly reduced versus baseline3White icon to describe impact on cardiovascular risk

Framingham Risk Score reduced from 13.9 at baseline to 11.3 at 12 months, n=62, p=0.0053

 

Sleep apnoea severity significantly reduced versus baseline4White icon for sleep apnoea

Apnoea–Hypopnoea index decreased from 23 at baseline to 18 at 6 months, n=12, p=0.074

 
Impact on aspects of glucose homeostasis of switching from octreotide LAR* to Somavert at 8 months
Bar graphs showing impact of treatment on glucose metabolism

 

Impact on blood pressure of Somavert-mediated IGF-I normalisation at 12 months (n=62)
Bar graph showing treatment impact on systolic blood pressure at 12 months

 

Impact of switching to Somavert (n=62) on Framingham Risk Score at 12 months3
Bar graph showing impact of treatment on CV risk score at 12 months

 

Impact on obstructive sleep apnoea (OSA) of switching to Somavert (n=12) at 6 months4
Graph showing change in sleep apnoea severity before and after treatment

 

 

 

References

  1. Barkan AL, et al. Glucose Homeostasis and Safety in Patients with Acromegaly Converted from Long-Acting Octreotide to Pegvisomant. J Clin Endocrinol Metab 2005;90(1):5684–91.
  2. Drake, et al. Insulin sensitivity and glucose tolerance improve in patients with acromegaly converted from depot octreotide to pegvisomant. Eur J Endocrinol 2003;149(6):521–7.
  3. Berg C, et al. Cardiovascular risk factors in patients with uncontrolled and long-term acromegaly: comparison with matched data from the general population and the effect of disease control. J Clin Endocrinol Metab 2010;95(8):3648–56.
  4. Berg C, et al. Influence of disease control with pegvisomant on sleep apnoea and tongue volume in patients with active acromegaly. Eur J Endocrinol 2009;161:829–35.
  5. Sandostatin® LAR® Summary of Product Characteristics. February 2020. Available at: https://www.medicines.org.uk/emc/product/1038/smpc (last accessed August 2020).
  6. Pasireotide Summary of Product Characteristics. May 2018. Available at: https://www.medicines.org.uk/emc/product/9396/smpc (last accessed August 2020).

PP-SOM-GBR-0631. August 2020.

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