Background/Purpose: Targeted immunomodulators (TIMs) have revolutionized the therapy of RA and made low disease activity (LDA) a realistic goal for patients. Given the multiple therapy options available, our goal was to quantify and describe the current state of unmet need by examining the proportion and characteristics of patients with moderate/high disease activity using real world registry data.

Methods: We identified patients in the Corrona RA registry ≥18 years old with ≥1‑year follow-up from 01/2012 to 06/2017. In a cross-sectional cut, we evaluated the percentage of patients with moderate or high disease activity (Clinical Disease Activity Index [CDAI] >10) at the last registry visit. Then, we estimated the number of patients on continuous therapy (no interruption in therapy >30 days) with a TIM ≥6 months before the last registry visit. Demographic/disease characteristics and treatment history were described. Patient reported outcomes (PROs) and disease activity in the 12 months before the last visit were assessed. PROs included mHAQ, pain, fatigue, Patient Global Assessment (PtGA), and morning (AM) stiffness duration. Percentages of patients with improvement ≥ minimum clinically important difference (MCID) from index visit to last registry visit were estimated.

Results: Of 30,100 patients with ≥1 year of follow-up, 10,400 (35%) had CDAI >10 at the last registry visit. Of these 5,090 were on continuous therapy with a TIM ≥6 months. In this cohort, mean age was 61 years, 81% were female, 87% were white, mean duration of RA was 14 years, 69% and 58% were seropositive for RF and CCP, respectively. Mean CDAI was 21.2, mean mHAQ was 1.2; 35% of patients had high disease activity (CDAI >22), 88% reported having AM stiffness and in 56% its duration was >1 hr. Approximately 39%, 26%, and 16% of patients were treated with their first, second, and third TIM, respectively; 85% were on the same TIM for ≥12 months. Out of 5,090 patients, 3,625 patients had a registry visit within 12 months prior to their most recent visit (index visit). Mean PRO scores at index and last registry visits are shown in Table 1; <25% reported improvements ≥ MCID in CDAI or PRO scores (Table 2).

Conclusion: For 35% of patients followed in the Corrona RA registry, LDA was not achieved. Half had been on a TIM >6 months. In most of these patients, disease activity remained high and patients had significant pain, fatigue, AM stiffness, and reduced physical function. These data clearly indicate that there is an unmet need for new effective therapies to help patients meet treat-to-target goals.

Medical writing services provided by Joann Hettasch (Fishawack Group, US) and funded by AbbVie.