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.

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.