Table 1.
Characteristics of clinical trials included in the mega-analysis. Placebo-controlled, randomized clinical trials of immunomodulatory drugs for treatment of inflammatory or oncological disorders were included if SF-36 or HADS data on depressive symptoms were available at baseline and a follow-up visit 4–16 weeks after randomization
| Clinical Trial ID | Study Drug | Number of Subjects (% high depressive) | Depressive Symptom Scale | Primary Disease | Primary Disease Symptom Scale | Treatment Arms | Follow-up Visit‡ | |
|---|---|---|---|---|---|---|---|---|
| Janssen Trials | ||||||||
| TNF-α | C0168T37*# | Infliximab | 358 (20%) | SF-36 v1.0 | Ulcerative Colitis | MAYO | Placebo (119:90) 5 mg (119:111), 10 mg (120:108) | 8 wk |
| C0168T41*# | Infliximab | 1025 (23%) | SF-36 v1.0 | Rheumatoid Arthritis | DAS28-CRP | Placebo (345:306) 3 mg (341:282), 10 mg (339:274) | 6 wk | |
| C0168T44# | Infliximab | 832 (13%) | SF-36 v1.0 | Psoriasis | PASI | Placebo (208:188) 3 mg (310:302), 5 mg (314:306) | 10 wk | |
| C0524T03# | Golimumab | 303 (10%) | SF-36 v1.0 | Asthma | FEV1 | Placebo (77:70) 50 mg (72:59), 100 mg (76:68), 200 mg (78:66) | 12 wk | |
| C0524T09* | Golimumab | 350 (18%) | SF-36 v1.0 | Ankylosing Spondylitis | ASAS20 | Placebo (76:76) 50 mg (136:131), 100 mg (138:135) | 14 wk | |
| IL-12/23 | C0743T08*# | Ustekinumab | 763 (8%) | SF-36 v2.0 | Psoriasis | PASI | Placebo (254:252) 45 mg (255:255), 90 mg (254:248) | 12 wk |
| C0743T09# | Ustekinumab | 1219 (27%) | HADS | Psoriasis | PASI | Placebo (405:396) 45 mg (405:401), 90 mg (409:404) | 12 wk | |
| IL-6 | C1377T04*# | Sirukumab | 176 (26%) | SF-36 v2.0 | Rheumatoid Arthritis | DAS28-CRP | Placebo (45:40) 100 mg/2wk (45:44), 25 mg/4wk (27:27) 50 mg/4wk (29:27), 100 mg/4wk (30:28) | 12 wk |
| MCD2001*# | Siltuximab | 77 (20%) | SF-36 v2.0 | Multicentric Castleman’s Disease | MCDOS | Placebo (26:25) 11 mg/kg /3wk (51:49) | 6 wk | |
| GlaxoSmithKline Trials | ||||||||
| CD20 | OFA110634* | Ofatumumab | 161 (34%) | SF-36 v2.0 | Rheumatoid Arthritis | DAS28-CRP | Placebo (79:65) 700 mg (82:57) | 16 wk |
| OFA110635* | Ofatumumab | 244 (29%) | SF-36 v2.0 | Rheumatoid Arthritis | DAS28-CRP | Placebo (122:112) 700 mg (122:105) | 16 wk | |
| Cox2 | CXA30007 | GW406381 | 1101 (10%) | SF-36 v2.0 | Osteoarthritis-Knee | WOMAC | Placebo (184:133) 1 mg (186:133), 5 mg (186:130), 10 mg (184:131), 25 mg (179:133), 50 mg (181:137) | 12 wk |
| CXA30009 | GW406381 | 1711 (20%) | SF-36 v2.0 | Rheumatoid Arthritis | DAS28CRP | Placebo (341:245) 5 mg (348:266), 10 mg (348:273), 25 mg (344:250), 50 mg (330:244) | 12 wk | |
| BlγS | BEL110751*# | Belimumab | 812 (16%) | SF-36 v2.0 | Lupus (SLE) | SELENA SLEDAI | Placebo (273:246), 1 mg (269:248), 10 mg (270:252) | 12 wk |
| BEL110752* | Belimumab | 860 (17%) | SF-36 v2.0 | Lupus (SLE) | SELENA SLEDAI | Placebo (288:277) 1 mg (285:274), 10 mg (287:276) | 12 wk | |
| LBS02*# | Belimumab | 445 (12%) | SF-36 v2.0 | Lupus (SLE) | SELENA SLEDAI | Placebo (113:103), 1 mg (114:104), 4 mg (111:104), 10 mg (107:100) | 12 wk | |
| P38 | KIP112967 | Losmapimod | 167 (17%) | SF-36 v2.0 | Neuropathic Pain | PI-NRS | Placebo (80:67), 7.5 mg (87:72) | 4 wk |
| KIP113049 | Losmapimod | 139 (12%) | SF-36 v2.0 | Neuropathic Pain | PI-NRS | Placebo (71:68), 7.5 mg (68:65) | 4 wk |
Annotations: *indicates inclusion in non-responder analysis, #indicates studies with significant treatment effect on primary endpoint (physical disease symptom severity scale), ‡follow-up visit indicates the week at which depression improvement was assessed in this study, and not the final endpoint for the study. MAYO Mayo Score for Ulcerative Colitis, DAS28-CRP Disease Activity Score using C-Reactive Protein, PASI Psoriasis Area Severity Index, FEV1 Forced Expiratory Volume 1, ASAS20 Assessment In Ankylosing Spondylitis Response Criteria, MCDOS Multicentric Castleman’s Disease Overall Score, WOMAC Western Ontario and McMaster Universities Arthritis Index, SELENA SLEDAI Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) modification of the SLE (Systemic Lupus Erythematosus) Disease Activity Index (SLEDAI) Score, PI-NRS Pain Intensity Numeric Rating Scale. Within the treatment arms column, the number of patients at the baseline line and follow-up visits are indicated in parenthesis as (Nbaseline:Nfollowup)