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SPEVIGO® safety profile

SPEVIGO® has a favourable benefit-risk profile1,2

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*All AEs occurring between the start of treatment and end of the residual effect period (16 weeks after the placebo dose or last dose of SPEVIGO®). AEs were coded using the MedDRA v23.1. AE severity was graded according to the RCTC v2.0. Pustular psoriasis was excluded as an AE from this safety analysis.2 

†Data set at Week 12 included patients randomised to SPEVIGO® who received up to 3 doses of SPEVIGO® and patients randomised to the placebo group who received OL SPEVIGO® at or after Day 8. All AEs in the residual effect period are included but censored at the day rescue treatment with SPEVIGO® was administered.2

‡Common AEs are reported in ≥10% of patients in any treatment group.2

No AEs led to treatment 
discontinuation2

Safety through Week 122

The time-adjusted incidence rates of adverse events in patients who received at least 1 dose of SPEVIGO® decreased from Week 1 to Week 12.

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§Not reported in Effisayil™ 1.1 

Injection site reactions1 

Injection site reactions include injection site erythema, injection site swelling, injection site pain, injection site induration, and injection site warmth. Injection site reactions were typically mild to moderate in severity.

SPEVIGO® may increase the risk of infections. During the 1-week placebo-controlled period in Effisayil™ 1, infections were reported in 17.1% of patients treated with SPEVIGO® compared with 5.6% of patients treated with placebo.1

GPP=Generalized Pustular Psoriasis; OL=open-label; RCTC=Rheumatology Common Toxicity Criteria.

SPEVIGO® has a favourable benefit-risk profile1,2

No AEs led to treatment discontinuation2

SPEVIGO® has a favourable benefit-risk profile1,2
SPEVIGO® has a favourable benefit-risk profile_2

Injection site reactions were typically mild-to-moderate in severity1

*All AEs occurring between the start of treatment and end of the residual effect period (16 weeks after the placebo dose or last dose of SPEVIGO). AEs were coded using the MedDRA v23.1. AE severity was graded according to the RCTC v2.0. Pustular psoriasis was excluded as an AE from this safety analysis.2 

†Data set at Week 12 included patients randomised to SPEVIGO® who received up to 3 doses of SPEVIGO® and patients randomised to the placebo group who received OL SPEVIGO® at or after Day 8. All AEs in the residual effect period are included but censored at the day rescue treatment with SPEVIGO® was administered.2

‡Common AEs are reported in ≥10% of patients in any treatment group.2


MedDRA=Medical Dictionary for Regulatory Activities; OL=open-label; RCTC=Rheumatology Common Toxicity Criteria.

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