ArticleRheumatology and therapy2026
Impact of the Sociodemographic Index on Efficacy/Safety of Tofacitinib in Patients with Rheumatoid Arthritis: Post Hoc Analysis of Phase 2/3/3b/4 Studies.
Article in Rheumatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 15 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone
A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis
Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors
An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis
Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis
An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis
A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate
A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis
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Authors and funding
6 authors.
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Abstract
introductionWe explored the impact of the Sociodemographic Index (SDI) on the efficacy/safety of tofacitinib and adalimumab in patients with rheumatoid arthritis (RA).
methodsThis post hoc analysis used data from phase 2/3/3b/4 studies of patients with RA receiving tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg every 2 weeks, or placebo. Patients were stratified into country-level SDI tertiles (low/medium/high; defined as Global Burden of Disease 2010 scores of ≤ 0.708/> 0.708-≤ 0.803/> 0.803). Efficacy/patient-reported outcomes were evaluated to month (M)3. We calculated incidence rates (IRs) for safety outcomes through M24. Pooled data are reported for tofacitinib 5 and 10 mg BID.
resultsPatients: low SDI, N = 1969; medium SDI, N = 1538; high SDI, N = 3071. There was a higher percentage of patients aged ≥ 50 years, ever smokers, and prior biologic disease-modifying antirheumatic drug users, and RA duration was longer, in the high vs low/medium SDI tertiles. Across SDI tertiles, efficacy at M3 was generally greater with tofacitinib or adalimumab vs placebo. Odds ratios vs placebo showed that American College of Rheumatology 20/70 responses at M3 for tofacitinib or adalimumab were numerically greatest (i.e., 95% confidence intervals [CIs] overlapped) in the high SDI tertile. Placebo-adjusted least squares mean change from baseline in Disease Activity Score in 28 joints with C-reactive protein/erythrocyte sedimentation rate and Clinical Disease Activity Index at M3 was greater in the high vs low/medium SDI tertile (95% CIs overlapped) with tofacitinib or adalimumab. For tofacitinib or adalimumab, IRs for adverse events/serious adverse events were numerically greatest in the high SDI tertile.
conclusionsEfficacy at M3 was at least numerically greater with tofacitinib or adalimumab vs placebo, regardless of SDI. Placebo-adjusted efficacy responses were at least numerically greater in patients from high SDI countries. Safety IRs were also generally numerically greatest in the high SDI tertile with tofacitinib or adalimumab. Results were confounded by differences in demographics/baseline characteristics and associated lifestyle factors between SDI tertiles.
trial registrationClinicalTrials.gov: NCT00147498, NCT00413660, NCT00960440, NCT00550446, NCT00603512, NCT00687193, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01164579, NCT01039688, NCT00976599, NCT01359150, and NCT02187055.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.