SARIL-RA-MONARCH Trial Reveals Sarilumab's Superiority to Adalimumab Through PROs

Patient-reported outcomes (PROs) have proved to be a vital tool in evaluating rheumatoid arthritis (RA) treatments. The SARIL-RA-MONARCH trial has shown that sarilumab has greater impact on many PROs than adalimumab does.

A debilitating disease, RA has a significant physical, psychological, and social impact on a patient’s daily life. Treatment starts with conventional disease-modifying therapies such as methotrexate but progresses toward biologic disease-modifying therapies due to the drug’s adverse events or disease progression. Sarilumab is a human immunoglobulin G1 monoclonal antibody that inhibits IL-6Rα. In a previous clinical trial, MONARCH, sarilumab monotherapy was superior in reducing disease activity and signs of RA compared with adalimumab, a tumor necrosis factor α inhibitor. The purpose of the trial, SARIL-RA-MONARCH, is to build upon the MONARCH trial and compare sarilumab to adalimumab through PROs.

Patients were randomized to receive either sarilumab 200 mg and placebo every 2 weeks or adalimumab 40 mg and placebo every 2 weeks for 24 weeks. PROs included multiple questionnaires and assessments that patients completed based on RA. These documents included:

• Patient Global Assessment of Disease Activity (PtGA)
• The 0- to 100-mm visual analogue scale (VAS) to evaluate pain and morning stiffness
• Health Assessment Questionnaire Disability Index (HAQ-DI) to evaluate physical functioning
• Short Form Health Survey (SF-36) assessing 8 health statuses, physical component summary (PCS), and mental component summary (MCS) scores
• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale to assess function
• Rheumatoid Arthritis Impact of Disease (RAID) questionnaire, a measurement of pain, disability, fatigue, physical/emotional well-being, sleep, and coping
• RA-specific Work Productivity Survey (WPS-RA), a 9-item assessment on employment status, absenteeism, presenteeism, and social and work interference

All PROs were reviewed at baseline, week 12, and week 24.

At week 24, both sarilumab and adalimumab improved all PROs. PtGA (P <.001), pain VAS (P <.001), HAQ-DI (P <.005), and SF-36 PCS (P <.001) scores were all significantly greater for sarilumab than adalimumab. Improvements in 4 of the 8 SF-36 domains—physical functioning and bodily pain (both P <.005), and role physical and social functioning (both P <.05), were also significantly greater with sarilumab than adalimumab. For morning stiffness, VAS (P <.05), RAID score (P <.001), and WPS-RA (P <.005) scores showed significant overall greater improvements in sarilumab compared with adalimumab. SF-36 MCS (P = .332) and FACIT-F (P = .069) scores did not show significant differences between the 2 treatment groups.

The proportion of patients meeting the minimum clinically important difference (MCID), also known as responders, was analyzed at week 24. Improvements greater than or equal to the MCID were higher for the sarilumab group compared with the adalimumab group for HAQ-DI (67.4% vs 54.1%; P <.01 [≥0.22 units] and 62.0% vs 47.6%; P <.01 [≥0.3 units]), SF-36 PCS (68.5% vs 54.1%; P <.005), RAID (43.5% vs 29.7%; P <.01), and morning stiffness (73.9% vs 62.2%; P <.05).

PROs are an important assessment because they allow the patient to report how the drug is working in a personal and clinical way. In this trial’s findings, sarilumab was shown to be superior to adalimumab in multiple patient-reported end points. For patients who have an intolerable or inadequate response to methotrexate, sarilumab monotherapy may be a suitable treatment option to help relieve the effects of RA and improve patient lives.

Reference

Strand V, Gossec L, Proudfoot CW, et al. Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis. Arthritis Res Ther. 2018;20(1):129. doi:10.1186/s13075-018-1614-z.