Sustained High Efficacy and Favorable Safety Over Five Years in Patients With Burdensome Psoriasis (UNCOVER-1/UNCOVER-2)

August 2021 | Volume 20 | Issue 8 | Original Article | 880 | Copyright © August 2021


Published online August 1, 2021

Kim A. Papp MD PhD FRCPC,a Sascha Gerdes MD,b Craig L. Leonardi MD,c Hany Elmaraghy MD,d Kyoungah See MS,d Missy McKean-Matthews MS,d Bruce W. Konicek MS,d Heidi M. Crane MD,d William Eastman MDd

aProbity Medical Research and K. Papp Clinical Research, Waterloo, Ontario, Canada
bPsoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany
cCentral Dermatology, St Louis, MO DEli Lilly and Company, Indianapolis, IN
dEli Lily and Company, Indianapolis, IN

Considering that PASI does not include nail assessment, it is possible that patients with PASI 100, or complete clearance, may have residual nail involvement. In patients with moderateto- severe psoriasis, significant reductions in NAPSI scores in patients treated with IXE were seen as early as 2 weeks and maintained through 5 years.7,17 Additionally, IXE was superior to ustekinumab in providing earlier complete clearance of nail psoriasis, with continued improvement through 52 weeks.20

Moderate-to-severe palmoplantar psoriasis is ill-defined. However, palmoplantar plaque psoriasis can be more debilitating than generalized plaque psoriasis. Patients with palmoplantar psoriasis experience significant functional impairment from the plaques on their palms and soles, which negatively affects their QoL.21 Our data suggest that high levels of response have been achieved with IXE in a large percentage of patients with palmoplantar psoriasis through 5 years, which is consistent with what has been reported previously.3 We also show here that high response rates were indicative of improved DLQI response throughout 5 years of treatment with IXE.

Taken together, long-term IXE treatment positively impacts QoL in patients with burdensome psoriasis. Clinical improvements in symptoms and QoL in patients with burdensome psoriasis with other biologics, specifically IL-17 inhibitors, up to week 80 have also been reported.9,11,12,19,22,23 Specifically, more than 74% of patients with nail psoriasis reported at least a moderate benefit and significant improvement with secukinumab at week 80.12 About 33% of patients with palmoplantar psoriasis achieved complete/almost complete clearance and improved QoL at 4 months with secukinumab.11

No new safety signals were reported over 5 years of IXE treatment in patients with burdensome psoriasis. The number of patients with either scalp, nail, or palmoplantar involvement reporting TEAEs generally decreased each year, which is consistent with what has been previously reported in IXE-treated patients with moderate-to-severe psoriasis up to 3 years24 and 5 years.16

While advances in psoriasis treatment have improved skin clearance, burdensome areas remain a challenge for patients. Long-term treatment recommendations and algorithms to guide prescribing decisions are lacking. Our study confirms that most patients present with psoriasis lesions in more than one burdensome area at baseline. Healthcare professionals should consider full skin clearance, including psoriasis in these burdensome locations that often go overlooked, as a primary goal for treatment.25 These data are relevant to dermatologists and healthcare professionals in terms of treatment selection for long-term management of scalp, nail, and palmoplantar psoriasis.

Our analyses included small numbers of patients presenting with one or multiple burdensome psoriasis areas at baseline, which was a limiting factor. Additionally, we were unable to separate the effects on QOL or function based on psoriasis location and disease severity at that location. Because the assessment of disease severity in burdensome psoriasis conditions is generally lacking, making comparisons among treatment options was not feasible.

CONCLUSION

Management of patients with burdensome psoriasis requires long-term treatment strategies that are effective without substantially increasing the risk of adverse events. Patients receiving IXE for 5 years sustained high rates of improvement in baseline scalp, nail, and palmoplantar psoriasis. Overall, QoL benefit was sustained with no unexpected safety signals. IXE is effective for long-term management of patients with baseline burdensome psoriasis.

DISCLOSURES

This study was sponsored by Eli Lilly and Company.

KAP is a consultant, speaker, investigator, scientific officer, steering committee member, and/or advisory board member for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/ Valeant Baxalt.

SG has been an adviser for and/or received speakers’ honoraria and/or received grants from, and/or participated in clinical trials for AbbVie, Affibody AB, Akari Therapeutics Plc, Almirall-Hermal, Amgen, Anaptys Bio, AstraZeneca AB, Biogen Idec, Bioskin, Boehringer-Ingelheim, Celgene, Dermira, Eli Lilly, Foamix, Forward Pharma, Galderma, Hexal AG, Incyte Inc., Janssen- Cilag, Johnson & Johnson, Kymab, Leo Pharma, Medac, MSD, Neubourg Skin Care GmbH, Novartis, Pfizer, Principia Biopharma, Regeneron Pharmaceutical, Sandoz Biopharmaceuticals, Sanofi- Aventis, Sienna Biopharmaceuticals, Takeda, Trevi Therapeutics, UCB Pharma, Vascular Biogenics. CLL is a consultant/Advisory Board member for Abbvie, Amgen, Boehringer Ingelheim, Dermira, Eli Lilly, Janssen, Leo, Pfizer, Sandoz, UCB and Vitae; an investigator for Actavis, Abbvie, Allergan, Amgen, Boehringer Ingelheim, Celgene, Coherus, Cellceutix, Corrona, Dermira, Eli Lilly, Galderma, Glenmark, Janssen, Leo Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Sienna, Stiefel, UCB and Wyeth; and on the speaker bureau for Abbvie, Celgene, Novartis, Sun Pharmaceuticals, Eli Lilly and UCB. HE, KS, BWK, HC and WE are all employees and shareholders of Eli Lilly and Company. MM-M is an employee of Syneos Health.

ACKNOWLEDGMENT

The authors would like to thank Gina Moore, MS, Syneos Health, for her editorial support.