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54.3% of patients achieved complete pustular clearance* at Week 11,2

With SPEVIGO®, 54.3% of patients achieved complete pustular clearance* at Week 11,2

With SPEVIGO®, 54.3% of patients achieved complete pustular clearance at Week 1.

 

*Pustular clearance defined as GPPGA pustulation subscore of 0 (no visible pustules).1 

†Data include all observed cases regardless of any other GPP medication used within the first week.2

‡Missing values or any use of other medication for GPP within the first week of the trial was regarded as non-response for the analysis of the endpoint.2

§Risk difference between placebo and SPEVIGO®: 48.7% (95% CI: 21.5, 67.2); 1-sided P=.0004.1,2

CI=confidence interval; GPP=Generalized Pustular Psoriasis; GPPGA=Generalized Pustular Psoriasis Physician Global Assessment.

SPEVIGO® delivered rapid and complete pustular clearance|| in 54.3% of patients at Week 11,3

Patient after SPEVIGO® treatment, showed pustular clearance at Week 1.

 

||Pustular clearance defined as GPPGA pustulation subscore of 0 (no visible pustules).1

IV=intravenous.

In Effisayil™ 1, pustular clearance was sustained with SPEVIGO® for the 12-week study period2

SPEVIGO® trial data for a 12 week period.

 

Pustular clearance defined as GPPGA pustulation subscore of 0 (no visible pustules).1

#Defined as an increase of ≥2 points in both the GPPGA total score and the pustulation subscore after a GPPGA total score of 0 or 1 had been reached.2

In Effisayil™ 1, flare control** was sustained with SPEVIGO® for the 12-week study period2

Flare control was sustained with SPEVIGO® for the 12 week study period.

 

**Flare control defined as GPPGA total score of ≤1 and was reported for the 12-week study period.2

††Persistent flare defined as ≥2-point GPPGA total score and ≥2-point GPPGA pustulation subscore.2

Flare control goes beyond pustular clearance1

In Effisayil™ 1, flare control‡‡ was sustained with SPEVIGO® for the 12-week study period2

Patient view of flare control was sustained with SPEVIGO® for the 12 week study period.

 

‡‡Flare control defined as GPPGA total score of ≤1 and was reported for the 12-week study period.2

In Effisayil™ 1, flare control§§ was sustained with SPEVIGO® for the 12-week study period2

Flare control was sustained with SPEVIGO® for the 12 week study period.

 

§§Flare control defined as GPPGA total score of ≤1 and reported for the 12-week study period.2 

||||Defined as an increase of ≥2 points in both the GPPGA total score and the pustulation subscore after a GPPGA total score of 0 or 1 had been reached.2

Patients reported a reduction in pain, redness, itching, and burning sensations when treated with SPEVIGO®2

Patients report clinically meaningful improvements.

 

  • Analysis included patients who have received up to 2 doses of SPEVIGO®2
  • Patients with missing values, any use of other GPP medication, or use of SPEVIGO® for a new GPP flare were excluded from analysis2 

FACIT=Functional Assessment of Chronic Illness Therapy; IQR=interquartile range; PSS=Psoriasis Symptom Scale; VAS=Visual Analogue Scale.

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References

  1. SPEVIGO® Summary of Product Characteristics. Boehringer Ingelheim Pharmaceuticals, Inc; 2022.

  2. Bachelez H, Choon SE, Marrakchi S, et al; for the Effisayil 1 Trial Investigators. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385(26):2431-2440. doi:10.1056/NEJMoa2111563

  3. Strober B, Kotowsky N, Medeiros R, et al. Unmet medical needs in the treatment and management of generalized pustular psoriasis flares: evidence from a survey of Corrona registry dermatologists. Dermatol Ther (Heidelb). 2021;11(2):529-541. doi:10.1007/s13555-021-00493-0

  4. Data on File. Boehringer Ingelheim Pharmaceuticals, Inc. 

  5. Bachelez H, Barker J, Ghoreschi K, et al. Efficacy of spesolimab for the rapid control of generalized pustular psoriasis flares: results from the placebo-controlled Effisayil™ 1 study. Oral presentation at: European Academy of Dermatology and Venereology 30th Congress; September 29-October 2, 2021; Virtual. Abstract #345. Accessed September 30, 2022. https://www.globalmedcomms.com/immunology/EADV2021/Bachelez_oral/oral-presentation

  6. Rentz AM, Skalicky AM, Dirk Esser D, et al. Reliability, validity, and the ability to detect change of the Psoriasis Symptom Scale (PSS) in patients with plaque psoriasis. J Dermatolog Treat. 2020;31(5):460-469. doi:10.1080/09546634.2019.1709612

  7. Gould D, Kelly D, Goldstone L, Gammon J. Examining the validity of pressure ulcer risk assessment scales: developing and using illustrated patient simulations to collect the data. J Clin Nurs. 2001;10(5):697-706. doi:10.1046/j.1365-2702.2001.00525.x