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Background: Disease activity, structural damage and progression impacts rheumatoid arthritis (RA) patients’ lives and therefore results in additional psychosocial distress. While inhibition of inflammation and structural changes have improved significantly following advances in pharmacological treatment of RA, the observed impact of disease modifying anti-rheumatic drugs (DMARDs) on important psychosocial outcomes is limited [1]. reclarit is an internet-based therapeutic digital health application designed for patients with RA. The application provides methods and exercises, particularly from cognitive-behavioural therapy, and follows a holistic approach to enhance mental quality of life.
Objectives: To evaluate the effectiveness and safety of the digital health application reclarit in adult patients with rheumatoid arthritis.
Methods: In this two-armed RCT conducted in Germany (DRKS00025256) patients (age > 18 years with RA) were randomized either to the intervention group (IG; reclarit in addition to standard of care/ SOC) or to the control group (CG; SOC only). Primary endpoint was the change in health-related quality of life (HRQoL) from baseline to month 3, as measured by the SF-36 mental component summary (MCS) score. Secondary endpoints included depression (PHQ-9), anxiety (GAD-7), fatigue (BRAF-MDQ), social work-related functioning (WSAS), pain (numerical rating scale 0-10), physical function (HAQ-DI) and safety.
Results: In total, 354 subjects were included and randomized, 170 to the IG, and 184 to the CG. At 3 months, HRQoL as assessed by SF-36 MCS was significantly higher in the IG as compared to the CG. In the ITT population, SF-36 MCS improved from 33.6 to 38.6 and from 34.2 to 35.7 in IG and CG, respectively. The effect was maintained at 6 months with an overall effect size of d =0.23 (Table 1). No difference was noted in the SF-36 physical component summary (PCS) score. Secondary endpoints related to psychosocial HRQoL also showed significant improvement in the IG. Fatigue improved from 33.8 to 27.67 vs. 31.1 to 30.7 ( d =0.21, p =0.003) in the IG vs. CG, respectively. The effect remained stable at month 6. Depression ( d =0.30, p <0.001), anxiety ( d =0.23, p =0.003), and social and work-related function ( d =0.06, p =0.028) improved significantly at month 3. No significant differences were observed regarding pain or physical function.
Results of the of the primary endpoint psychological health-related quality of life (SF-36 MCS)
| ITT | Time | CG | IG | ANCOVA | ||||
|---|---|---|---|---|---|---|---|---|
| mean | SD | mean | SD | Treatment effect (95% CI) | p-value | Cohen’s
d
|
||
| T0 | 34.2 | 9.7 | 33.6 | 9.8 | - | - | - | |
| T1 | 35.7 | 12.6 | 38.6 | 12.8 | 3.3 (0.7, 5.9) | 0.014 | 0.23 (0.001, 0.046) | |
| T2 | 36.4 | 13.5 | 39.4 | 12.6 | 3.3 (0.5, 6.2) | 0.020 | 0.23 (-0.007, 0.46) | |
(ITT = intention to treat), T1= 3 months, T2= 6 months), IG= intervention group, CG = control group
Conclusion: In this RCT the digital health application significantly improved psychological HRQoL after 3 months. The effect was stable at the 6-month follow-up.
REFERENCES: [1] F. Matcham et al. , “The impact of targeted rheumatoid arthritis pharmacologic treatment on mental health: a systematic review and network meta-analysis,” Arthritis Rheumatol. , vol. 70, no. 9, pp. 1377–1391, 2018.
Acknowledgements: NIL.
Disclosure of Interests: Gitta Jacob GAIA AG, Hamburg, Germany, Oliver Bültmann GAIA AG Hamburg, Michaela Köhm Abbvie, Pfizer, Roche, Chugai, UCB, BMS, Amgen, Celgene, MSD, Novartis, Janssen, Lilly, Sanofi, Biogen, Abbvie, Pfizer, UCB, BMS, Celgene, Amgen, Novartis, Janssen, Lilly, MSD, Sanofi, Abbvie, Pfizer, Roche, Chugai, Prophylix, Rallybio, BMS, Novartis, Amgen, Janssen, Frank Behrens Abbvie, Pfizer, Roche, Chugai, UCB, BMS, Amgen, Celgene, MSD, Novartis, Janssen, Lilly, Sanofi, Biogen, Abbvie, Pfizer, UCB, BMS, Celgene, Amgen, Novartis, Janssen, Lilly, MSD, Sanofi, Abbvie, Pfizer, UCB, BMS, Celgene, Amgen, Novartis, Janssen, Lilly, MSD, Sanofi, Linda Betz GAIA AG, Hamburg, Germany.