Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS)

Abstract

Background: SDZ-ADL (GP2017; Sandoz GmbH, Austria) is an EMA-/FDA-approved adalimumab biosimilar. The effect of SDZ-ADL on quality of life (QoL) and patient-reported outcomes (PROs) was assessed as part of two phase III studies, one in patients with moderate-to-severe chronic plaque psoriasis (PsO; ADACCESS) and the other in patients with rheumatoid arthritis (RA; ADMYRA). Additionally, ADACCESS included patients with psoriatic arthritis (PsA).

Methods: ADACCESS included 465 patients with PsO, whereas ADMYRA included 353 patients with RA. Both studies evaluated and confirmed equivalent efficacy, similar safety, and immunogenicity of SDZ-ADL with reference adalimumab (ref-ADL). A third of patients underwent multiple (four) treatment switches between study treatments starting at Week 17 (ADACCESS); all patients switched from ref-ADL to SDZ-ADL at Week 24 (ADMYRA). Assessed PROs included Dermatology Life Quality Index (DLQI) and EuroQol five-dimension health status questionnaire (EQ-5D-5L) in ADACCESS, Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) score in ADMYRA, and Health Assessment Questionnaire-Disability Index (HAQ-DI) in both studies.

Results: In both studies, baseline scores for all PRO assessments were comparable between the two treatment groups. In ADACCESS, mean DLQI decreased from baseline in both groups, and the mean (standard deviation [SD]) percent reductions from baseline in DLQI were comparable between groups at Week 17 (SDZ-ADL, - 64.5 [80.3]; ref-ADL, - 70.6 [41.7]), which were sustained after the switch at Week 51 ('continued SDZ-ADL,' - 79.7 [36.2]; 'continued ref-ADL,' - 80.8 [44.6]; 'switched to SDZ-ADL,' - 70.7 [32.2]; 'switched to ref-ADL,' - 69.3 [49.6]). In ADACCESS, the proportion of patients with an EQ-5D-5L score of 1 (no problems) increased from baseline for all five dimensions in all treatment groups and was comparable between treatment groups at Week 51. In ADACCESS, in patients with PsA at baseline, mean (SD) HAQ-DI scores decreased from baseline in both treatment groups, and scores were comparable between groups at Week 17 (SDZ-ADL, 0.5 [0.6]; ref-ADL, 0.5 [0.6]) and after switching at Week 51 ('continued SDZ-ADL,' 0.4 [0.5]; 'continued ref-ADL,' 0.4 [0.6]; 'switched to SDZ-ADL,' 0.5 [0.8]; 'switched to ref-ADL,' 0.7 [0.6]). In ADMYRA, proportion of patients achieving HAQ-DI in the normal range (≤ 0.5) was comparable between treatment groups at Week 24 (SDZ-ADL, 37.8%; ref-ADL, 36.3%) and after switching at Week 48 ('SDZ-ADL,' 41.6%; 'ref-ADL/switched to SDZ-ADL,' 40.0%). In ADMYRA, mean FACIT-Fatigue scores increased from baseline in both treatment groups. At Week 24, mean (SD) percent change from baseline in the FACIT-Fatigue scores was 75.4 (135.5) in SDZ-ADL and 73.0 (96.3) in ref-ADL groups; the scores were sustained after switching at Week 48.

Conclusion: Treatment with SDZ-ADL and ref-ADL resulted in comparable improvements in PROs as well as QoL scores across the three diseases, PsO, PsA, and RA. Switching between SDZ-ADL and ref-ADL had no negative impact on PROs across the reported period. CLINICAL TRIALS.

Gov identifier: NCT02744755, NCT02016105.

Conflict of interest statement

Andrew Blauvelt: Received honoraria from Sandoz for scientific consulting. His company, Oregon Medical Research Center, received funds to conduct the clinical study reported herein. Also, he has served as a scientific adviser and/or clinical study investigator for Sandoz, AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte, Janssen, Leo, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma. Craig L. Leonardi: Consultant and/or advisory board member for AbbVie, Amgen, Boehringer-Ingelheim, Dermira, Eli Lilly, Janssen, Leo, Pfizer, Sandoz, UCB and Vitae; Speaker bureau for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Ortho Dermatologies, Sun Pharmaceuticals, and UCB; 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; writing assistance received from Sandoz. Norman Gaylis: None declared. Julia Jauch Lembach: Employee of Sandoz. Alison Balfour: Employee of Sandoz. Lena Lemke: Employee of Sandoz. Sohaib Hachaichi: Employee of Sandoz. Ines Brueckmann: Employee of Sandoz. Teodora Festini: Employee of Sandoz; stock/stock options as Sandoz employee, not related to publication. Piotr Wiland: Participation in clinical trial ‘ADMYRA’, received the fee as principal investigator in his center.

Figures

Fig. 1

Percent change in DLQI from baseline to Week 51 in patients with moderate‐to‐severe plaque PsO (ADACCESS study; TP2 + EP FAS). The vertical bars represent SD. TP2 + EP FAS consists of all patients who were re-randomized into TP2. Patients were analyzed according to the treatment assigned at re-randomization. DLQI scores range from 0 to 30, with higher scores indicating greater impairment in the health-related quality of life. DLQI Dermatology Life Quality Index, EP extension phase, FAS full analysis set, PsO psoriasis, ref-ADL reference adalimumab, SD standard deviation, SDZ-ADL Sandoz biosimilar adalimumab, TP2 treatment period 2

Fig. 2

Mean EQ-5D-5L scores up to Week 51 in patients with moderate‐to‐severe plaque PsO (ADACCESS study; TP2 + EP FAS). TP2 + EP FAS consists of all patients who were re-randomized into TP2. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned at re-randomization. EQ-5D-5L visual analog scores range from 0 to 100, with lower scores indicating greater impairment in the health-related quality of life. BL baseline, EP extension phase, EQ-5D-5L EuroQol five-dimension health status questionnaire, FAS full analysis set, PsO psoriasis, ref-ADL reference adalimumab, SD standard deviation, SDZ-ADL Sandoz biosimilar adalimumab, TP2 treatment period 2

Fig. 3

Mean percent change from baseline in HAQ-DI total scores up to Week 51 in patients with PsA (ADACCESS study; TP2 + EP FAS). TP2 + EP FAS consists of all patients who were re-randomized into TP2. Patients were analyzed according to the treatment assigned at re-randomization. Each item in HAQ-DI is scored on a four-point scale from 0 to 3, representing ‘without any difficulty’ (0), ‘with some difficulty’ (1), ‘with much difficulty’ (2), and ‘unable to do’ (3). EP extension phase, FAS full analysis set, HAQ-DI Health Assessment Questionnaire Disability Index, PsA psoriatic arthritis, ref-ADL reference adalimumab, SD standard deviation, SDZ-ADL Sandoz biosimilar adalimumab, TP2 treatment period 2