Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up

Abstract

Background: Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time.

Objectives: To evaluate the long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis.

Methods: LIMMitless is an ongoing, phase III, open-label extension study evaluating the long-term efficacy and safety of RZB in adults with moderate-to-severe plaque psoriasis following multiple phase II/III studies. This analysis assessed efficacy through 172 weeks of continuous RZB treatment by examining the proportion of patients achieving ≥ 90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90 and PASI 100), static Physician's Global Assessment of clear or almost clear (sPGA 0/1) and Dermatology Life Quality Index of no effect on quality of life (DLQI 0/1). Safety was assessed by recording adverse events (AEs) through the data cutoff date. The study is registered at ClinicalTrials.gov (identifier: NCT03047395).

Results: Of 955 patients randomized to RZB 150 mg in the base studies, 897 patients continued into LIMMitless; 799 patients were still receiving treatment in LIMMitless at the time of data cutoff for this analysis. After 172 weeks of continuous RZB treatment, 85·5% of patients achieved PASI 90, 54·4% achieved PASI 100, 85·2% achieved sPGA 0/1, and 78·4% achieved DLQI 0/1 using modified nonresponder imputation. Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable with those identified in the base studies.

Conclusions: Overall, long-term continuous RZB was well tolerated and showed high and durable efficacy over 172 weeks.

© 2021 AbbVie Inc. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Figures

Figure 1

Patient disposition. RZB, risankizumab.

Figure 2

Patients achieving improvement in Psoriasis Area and Severity Index (PASI). Proportions of patients achieving (a) ≥ 90% improvement in PASI and (b) 100% improvement in PASI. aBecause of differences in base study lengths, some patients enrolled in LIMMitless earlier than 52 weeks. b675 of the 722 ongoing patients completed the assessment visit at week 172; 47 ongoing patients have reached the assessment window but have not yet completed the assessment visit at week 172. CI, confidence interval; LOCF, last observation carried forward; mNRI, modified nonresponder imputation; OC, observed cases.

Figure 3

Patients achieving static Physician’s Global assessment of clear or almost clear (0 or 1). aBecause of differences in base study lengths, some patients enrolled in the LIMMitless study earlier than 52 weeks. b675 of the 722 ongoing patients completed the assessment visit at week 172; 47 ongoing patients have reached the assessment window but have not yet completed the assessment visit at week 172. CI, confidence interval; LOCF, last observation carried forward; mNRI, modified nonresponder imputation; OC, observed cases.

Figure 4

Patients maintaining Psoriasis Area and Severity Index (PASI) response from 52 to 172 weeks of continuous risankizumab treatment. Proportions of patients maintaining (a) ≥ 90% improvement in PASI and (b) 100% improvement in PASI. CI, confidence interval; LOCF, last observation carried forward; mNRI, modified nonresponder imputation; OC, observed cases.

Figure 5

Patients achieving a Dermatology Life Quality Index score of 0 or 1 (no effect on quality of life). aBecause of differences in base study lengths, some patients enrolled in the LIMMitless study earlier than 52 weeks. b697 of the 722 ongoing patients completed the assessment visit at week 172; 25 ongoing patients have reached the assessment window but have not yet completed the assessment visit at week 172. CI, confidence interval; LOCF, last observation carried forward; mNRI, modified nonresponder imputation; OC, observed cases.

Figure 6

Patients achieving both ≥ 90% improvement in Psoriasis Area and Severity Index and Dermatology Life Quality Index score of 0 or 1 (no effect on quality of life). aBecause of differences in base study lengths, some patients enrolled in the LIMMitless study earlier than 52 weeks. b674 of the 722 ongoing patients completed the assessment visit at week 172; 48 ongoing patients have reached the assessment window but have not yet completed the assessment visit at week 172. CI, confidence interval; LOCF, last observation carried forward; mNRI, modified nonresponder imputation; OC, observed case.