2113: Impact of Sociodemographic Factors on Efficacy and Safety of Tofacitinib in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of Phase 2/3/3b/4 Studies

Grace Wright¹, Eduardo Mysler², Kevin Roberts³, Lindsay Sweet⁴ and Ahmed Shelbaya⁵, ¹Grace C Wright MD PC, New York, NY, ²Organizacion Medica de Investigacion, Buenos Aires, Argentina, ³Pfizer Inc., Cambridge, MA, ⁴Pfizer Inc., Collegeville, PA, ⁵Pfizer Inc., New York, NY

Background/Purpose: Sociodemographic factors can impact treatment response and safety outcomes in patients (pts) with RA. Here, we explore the impact of sociodemographic index (SDI) on the efficacy and safety of tofacitinib and adalimumab in pts with RA.

Methods: This post hoc analysis used pooled data from Phase 2/3/3b/4 studies of pts with RA receiving tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg every 2 weeks, or placebo (PBO). At a country level, pts were stratified into low, medium, or high SDI tertiles, defined as scores of ≤ 0.708, > 0.708 to ≤ 0.803, or > 0.803, respectively, using the Global Burden of Disease 2010 criteria. Efficacy outcomes assessed at Month (M)3 included ACR20/50/70 responses (odds ratios for active treatment vs PBO calculated via logistic regression models, by SDI tertile) and change from baseline (∆) for DAS in 28 joints, ESR (DAS28-4[ESR]; PBO‑adjusted, assessed for active treatments via a mixed model of repeated measures, by SDI tertile). Incidence rates (IRs; pts with first events/100 pt-years) for safety outcomes to M24 were calculated for each treatment group, by SDI tertile.

Results: Of pts included (low SDI, N=1,969; medium SDI, N=1,538; high SDI, N=3,071), there was a higher percentage aged > 50 years, located in North America, of ever smokers and prior biologic DMARD users, and RA duration was longer, in the high vs low/medium SDI tertiles (Table 1). Across SDI tertiles, efficacy at M3 was generally greater with tofacitinib and adalimumab vs PBO (Fig 1). Odds ratios vs PBO showed that ACR20/50/70 responses at M3 for tofacitinib and adalimumab were generally numerically greatest in the high SDI tertile, but 95% confidence intervals (CIs) overlapped between tertiles (Fig 1a). PBO‑adjusted ∆DAS28-4(ESR) at M3 was numerically greater in the high vs medium/low SDI tertile with tofacitinib and adalimumab (Fig 1b). In the PBO group at M3, fewer pts in the high vs low SDI tertile achieved ACR20/50/70 (ACR20: 25.3% [113/447] vs 35.1% [71/202]); similarly, mean ∆DAS28-4(ESR) was smaller in pts with high vs low SDI (-0.58 [N=406] vs -1.17 [N=173]). Across treatments,IRs for safety outcomes were generally numerically greatest in the high SDI tertile, but 95% CIs overlapped between tertiles (Table 2).

Conclusion: Pts with RA responded better to active treatment vs PBO at M3, regardless of SDI. Across efficacy outcomes, PBO-adjusted treatment responses were generally numerically greatest in the high SDI tertile; PBO responses were lowest in this tertile. IRs of adverse events were generally numerically highest in the high SDI tertile, in all treatment groups. 95% CIs overlapped for numerical differences between tertiles. Results were confounded by differences in baseline smoking status, prior biologic DMARD use, concomitant medications, and RA duration between SDI tertiles. Data represent SDI at country level, which does not account for within-country variation.


Study sponsored by Pfizer. C Kinch, Pfizer, was involved in the conception/development of these analyses. G Schroeder, Syneos Health (paid contractors of Pfizer), was involved in data collection/analysis/interpretation. Medical writing support provided by L Hogarth, CMC Connect; funded by Pfizer.








G. Wright: AbbVie, 2, 6, Amgen, 2, 6, Association of Women in Rheumatology, 4, AstraZeneca, 2, 6, Bristol Myers Squibb, 5, Eli Lilly, 2, 6, Gilead Sciences, 5, GSK, 2, 6, Janssen, 2, 5, 6, Novartis, 2, 6, Pfizer Inc, 2, 5, 6, UCB, 2, 6; E. Mysler: AbbVie, 1, 2, 6, Amgen, 6, AstraZeneca, 1, 5, 6, Bristol Myers Squibb, 5, GSK, 2, 5, Janssen, 1, 5, 6, Lilly, 5, 6, Novartis, 5, Pfizer, 1, 2, 6, Roche, 5, Sandoz, 6; K. Roberts: Pfizer Inc, 3, 11; L. Sweet: Pfizer Inc, 3, 11; A. Shelbaya: Pfizer Inc, 3, 11.